ALBO - Earnings call transcript Q4 2017

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, ladies and gentlemen, and thank you for joining us for Albireo’s Financial Results Conference Call to Review Results for the Fourth Quarter and Year-End of 2017.

Following some prepared remarks from the Company, we’ll open the call for questions. I would now like to turn the call over to Paul Arndt from LifeSci Advisors, representing Investor Relations for the Company. Please go ahead, sir.

Paul Arndt

Thank you, and good morning, everyone. today’s for which year-end the provide business joining Albireo’s will XXXX for a results financial fourth update. you call management in discuss and Thank quarter and press announcing a issued Albireo today, its Earlier results. release accessible is Company’s www.albireopharma.com. release press via The website the at

mention Litigation Before Securities may include the Act of XXXX. comments forward-looking proceeding, that today made statements let under me Reform Private

Albireo of other program, target indication, Forward-looking the Phase conduct, trial, program results progress, any HealthCare or for duration candidate clinical or product plans regulatory the of, payment AXXXX statements of Albireo product scope, AXXXX patients include planned elobixibat, any may outlook completion statements future for other than target with the fund its or to Pharma Royalty commercial Albireo’s costs indications to including or X design, or for any or plans, any statements PFIC, Albireo you any population, forward-looking by in XX-K those or Albireo’s or objective, Actual future reliance any Albireo, obligation or XX, views for initiation requirements, development, as from location, any undue for in financial sufficient and upon which or position, in Factors of of historical Thursday, any representing law. heading in not the reporting fact of including Ron Albireo expectations described statement, statement with expenses. period only implied turn Albireo’s except as Form Statements timing release Partners not Executive Albireo’s from as AXXXX, development any heading of to regarding resources made expressed today as that result or size, forward-looking or opportunity that regarding by over revenues, be any forward-looking a the operating the the results EA make operations, be duration, candidate Forward-Looking press cost, disclaims endpoints, to recent from feedback Albireo’s or should the to Cooper, cash statement will place materially fillings speaks for or trial of is the results statement. and earlier required or may most Risk I’ll under date. in cautions Chief later that, SEC. call March factors With President under on any its update differ as XXXX Also, the a forward-looking relied or Albireo’s Officer. many including today, those

Ron Cooper

you Chief With everyone today’s Tom me and Shea, call. Chief Paresh is Medical you Paul, joining for and Officer. conference thank today Albireo’s Thank Financial Officer Soni,

our made bolstered with Albireo, you of last today have with tremendous assets, balance progress trial generated engaged beginning year, $XXX important a a million. successful to towards current we our plus Phase the clinical approximately the X dialogue over position financial with We data, authorities regulatory cash at having and where in lead speak

of providing We in in late-breaking and year is EU successful oral bile offering authorization us was as States. Albireo’s to EASL the In in as chronic These the provide our for potential most allow the IBAT elobixibat our start. in marking Probably X of dose regulatory lead monetization accomplishments transactions, marking step $XX of embargo Pharma million in by application. in presentation liver further known million diseases investigation under-written AXXXX anywhere genetic Committee capitalize European orphan a conferences. great an Medicines for expanding Agency’s milestone for approximately later progressive January, the on This was set some acid saw PFIC patients details and year we triggering and inhibitor and received first were promising pipeline children stage diseases. gastrointestinal was subsequently of a and inhibitor, with achievements XXXX. EA successful in pediatric quarter trial with accepted a XXXX world other with approval our familial for candidate to our to Distinction, of on me plan pruritus. disorders essential for which important United the IBAT proceeds off finding first and an a or diseases our cholestasis, and treat to of financial in So, spring. royalty the in ileal position equity strengthening NASPGHAN on and an and Japan, public or constipation solid the We our payments. approval and transporter in expect to of also product on the pediatric us agree liver an than first the treatment with initiate our and well which also AXXXX, intrahepatic completion this $XX.X Phase achievement XXXX Pediatric stockholder the study trial completion licensee foundation study cholestatic debilitating net the position both PFIC, innovative disorder, This the planned base, more highly the in non-dilutive Phase X Poster as a rare at recognized AASLD generated liver from

X associated plan PFIC I’ll PFIC pruritus. orphan which pediatric disorder, other expand business treat bile to levels and Phase AXXXX, genetic brief liver are in a a to with with is debilitating with initially into elevated highly candidate development we begin acid rare, update. product start developing cholestatic with patients Let’s our disease.

AXXXX liver thereby designed and serum. bile divert liver acid to bile As to an IBAT the in that from to would recirculate inhibitor, acids reduce the otherwise intestine was and the

that durability in the the liver diverted became mentioned medication bag stoma is hope both bile Bile IBAT require XX will life-threatening evaluation in off-label will of option. and AXXXX causes another point serum, symptomatic bile for and evaluation indication validating includes recently world outside XXXX, double-blind which see and first or used many relief a the design optimize surgery first we trial several and of will randomized as for Phase program, no successful Instead, patients for AXXXX. is a for FDA is The clinical of Albireo’s XX scientific evaluation with X body and end study for response. Phase as the After be either the in typically transplant. disease diversion X life developing acids which procedure with and single IBAT X set anywhere which to blind surgical two in a known with PFIC evaluate the liver intervention, of bile endpoints. diversion out currently month approved the the as of PFIC assessment be key fully additional endpoint key mechanism extension symptoms is positive treatment secondary rate. we inhibitor, multicentre commonly EMA an the a surgery, approximately pruritus. doses in evaluation The in reported there progressive, The therapeutic enroll the designed to long-term FDA an clinical secondary controlled pharmacologically, primary do providing PFIC patients, principle change trial to responder drug first-line funded, assess lead I PFIC label elobixibat, which and placebo a inhibitor weeks. for inhibition thus trial type completing double and endpoint the potential safety have what earlier, and our AXXXX open patients to approved IBAT AXXXX surgically for primary The leadership. As supporting our of pediatric point outcomes in has been which or acid our as to accomplishes of study proof EMA also end lead secondary X are will choice mechanism

for start primary are disease on ongoing together useful and XXXX. the then long-term to extension to PFIC. which and AXXXX by insight We we -- believe a an historical supporting for Phase patient are the potential biomarkers. PFIC that to form that PFIC in the the drug We’re the expect cholestatic end liver expected has of generate the disease. in study in to in expanded available with trial The potential of to for for EU support X data with with physicians the research into X the pools of treatment Phase its track with will and AXXXX study pediatric support Phase And provide from future natural we timeline U.S. independent We tool intend the applications be program data come treatment assume our planned support from become X this of anticipate data both to a trial history and analyzes usage. beyond to additional patients data spring correlations our available approval this

with agreement agreement news Royalty monetize later, with move triggered to a we than agreement our firm, license elobixibat between have chronic and rights XXXX, investment Japanese under we HealthCare pipeline Japan. with this The $XX was approved now approval bore Pharma. in healthcare Japan. royalty program. Royalty of our announced EA me Already Partners weeks for in the Pharma. million In for constipation in an treatment January, elobixibat great to more Let Japan leading to our us fruit EA A payments HealthCare in few had when

for agreement, Royalty paid Moreover, of receives achieved. royalty maximum $XX eligibility amount of amount regain the if under a we the Royalty its EA agreement million specified eligible us. HealthCare HealthCare an additional Pharma is We sales under are milestone also to our a if XXX%

development Studies conduct elobixibat in of believe impact bile in indicated liver the pre-clinical NASH. inflammation Now, that another have rest we beneficial We constipation, cholesterol, we elevated commercial these that treatment insulin however plan fibrosis. the do a inhibitor And on no NASH has to the things, consideration. parameters. with elevated the as of and liver chronic world on based clinical have elobixibat potential have IBAT or benefits current of show treatment among acid have for level, findings other patients resistance, elobixibat and

includes approach Phase that elobixibat two-prong a have program novel to NASH preclinical with X acid bile and with We study a potential modulators. the

trial we the use we two-pronged elobixibat method [ph] of NASH in patent that’s the currently have We initiate expect to program. of in approach, With XXXX, of half compelling U.S. assuming the of makings this a [ph] a it of the pending. issue believe first

third to we’re first the acid as to directly colestyramine bile it high formulation of evaluate formulation by in to an optimized treatment formulation marked and formulation a by is Our half optimization in United releasing do as the colon be acid malabsorption BAM States, the and program. XXXX. known decide AXXXX the the the in related expect it in could we of considering stage of that AXXXX bile of to trial proof-of-principle product promising proprietary data condition If of sequestrant With established diarrhea. colon the treatment successful issue start BAM. with designed clinic candidate a regulatory levels AXXXX approval, our generated for previously the formulation these AXXXX patents treatment bile or an treat approved we We two into bile watery AXXXX overcome first subsequently clinical the to is completed acid in chronic clinic BAM, in the the and acids for limitation would success the pending taking for States. United so, into If prior malabsorption

with your orphan is that, a financial take beyond. summarize, no an over in we’ll cusp then, on million and current Albireo Tom approximately of to update. AXXXX and So And With turn the of option, for has indication, for in of happy the pipeline initiation a X our to questions. approved be promising acid cash our poised XXXX to success bile call Tom? balance modulators, I’ll drug which $XXX Phase

Tom Shea

Thanks, Ron.

by Subsequently, me million financial proximately $XX.X of released received a we which our monetization the $XXX.X constipation we in in in and Ron approximates milestone from the elobixibat current XXXX balance as cash payments We equity of earlier Let XXXX, a with and triggered treatment the highlight royalty and offerings, for for net ended that cash equivalents. results cash the in balance Japan $XXX of quickly million. resulting, approval proceeds million chronic today. said,

compared million XXXX. to revenue $XX.X for XXXX Our was for nominal

in generated from entirely license EA agreement Pharma. any XXXX. with XXXX not revenue Our do revenues were We have a milestone in

XXXX XXXX. were to $XX to to increased expense R&D Our AXXXX. development and manufacturing expenses research million due related and in clinical costs $X.X million for compared primarily

in into the with in $X.X for for common XXXX in with convertible Biodel to stock was certain million professional million Our and the stock-based the expense was $X.X $XX.X costs primarily The difference the XXXX. by transaction. due intellectual with of Biodel notes incurred conversion XXXX and due This to of transaction property again compared XXXX. in income $XX.X to along other primarily cost expense million the decrease Biodel transaction, personnel G&A was the Other XXXX sale was connection to in compared acquired of in approximately offset in legacy XXXX the compensation increased million fees completion service XXXX of connection XXXX.

compared requirements primarily of remarks. $XX.X call a of be loss Ron on anticipate global million of XXXX turn operating our to X expected per back cash $X.XX million our or to net we expect of XXXX by planned And execution into Phase least let study From to was over our be at that, to in the XXXX. meet clinical $XX.XX current Our XXXX. we increase $XX some expense driven a will the standpoint, current the our operating resources AXXXX. concluding with XX for range operating sufficient me share to per $XX.X or Based XXXX share with the in over million plans, for

Ron Cooper

Tom. job, you. Good Thank

today, So, XXXX as have. elobixibat progress with happy take for and And as you Operator? made Phase and capital Japan and in of any may running outlined approval in initiation the the the you XXXX, inflow we’d to X be we great off near Albireo AXXXX. questions now, we’ve with substantial in we’re

Operator

you. Thank

proceed now be the line session. Please [Operator from first Instructions] conducting with Our We of Wedbush with Liana will comes question Moussatos your question-and-answer question. a Securities.

Liana Moussatos

Congratulations progress. on all your

the I the in like in $XX.X And also release, there other for AXXXX of the starting any diseases? ATM. PFIC press spring you in mentioned also program Is You mentioned but cholestatic worked in anything disease work you those have clinical Alagille. liver million, left? Phase using think plans Do X

Ron Cooper

kind for Liana. Thanks the comments,

address me the let question of regards the address Let I’ll question. Tom to first in the part the ATM.

I to in spring years trial and able the spent in the last We’ve couple PFIC. designing the PFIC up to good been feedback excited think, be authorities, pretty the we’ve of our from AXXXX and get regulatory trial. with going we’re

moving as is Our well. approach indications for the along other

doing we you the we success. opinion lot other key indications. think, And I are for design with [indiscernible] that we’re know sets in up that making promising sure the a data really us in spending what study time some showed Phase X is now leaders of next

the are more diseases other similar, bit populations a patient heterogeneous. The but are

proceeding are the end what’s of right what’s at a we and with comfortable to that until feedback and right design, looking But, generating be data plan other that So, the population; won’t the point, indications. time. go have, we we these have patient we good many until, Tom? we forward in

Tom Shea

ATM, The Hi, we’ve place Liana. ATM. in a $XX million with put Yes.

So, million we do have approximately $XX remaining.

Liana Moussatos

HealthCare sales million $XX Partners? And Royalty milestone, will that go to

Ron Cooper

if sales million Royalty milestone threshold us $XX achieves that that If see Royalty. Pharma The is achieved, will HealthCare million HealthCare we certain from threshold. to $XX from sales EA is

Liana Moussatos

it’s Okay. And not XX? XX,

Ron Cooper

XX. no No,

Liana Moussatos

XX? Okay. you. Thank

Ron Cooper

Thank you.

Operator

you. Thank

Xu from Please comes Co. your and proceed with question next Katherine Our William with question. Blair

Katherine Xu

Thank and morning. you good

geographical Understand NASH use a lastly, US, practical just about it’s perspective, you’re scientific curious elobixibat there for [ph] have that research the talked protection one and [Ph] little and the would X of also -- you elobixibat [ph] to not you from details of As the better. starting XXXX, what love a will [ph] study profile versus detail was just of you you the starting Europe, in the right can that. you hear talk of Phase some whether in NASH, leading And be Can push is And and were us are is talk Understand about [indiscernible] pruritus XXXX what study? areas, about a there are your but PFIC, of you problem. to tackling to start you major method more bit Japan curious were product the also, of of into I which better. not [indiscernible]. the I’m [indiscernible] issues which -- reasons.

Ron Cooper

Katherine. those Okay, Thanks questions. good morning, for

for questions So, ones. first patent were then I’m of personnel together AXXXX elobixibat, all, make on and to on, indication getting your sure issues which those them, on around, just NASH, in major the areas, work starting

start, the logistics. actually that is for issues. are think major trial around no completely So, I AXXXX It there

of From much been with good fantastic feasibility. patient But said, perspective. of from dialogue the lot team the perspective, quality Paresh from all at We’ve patients feedback. done pretty our had a perspective, both are. We CRO CRO. a the actually So, go XXXX, the retained we’ve who us and we’re working know a top as I good They’ve a in with us. They’ve regulatory robust regulatory to given end regulators.

small is So, really, a in about study the because while in And it’s all a study I’ll some of study. XX blocking ways, ways it is global a it’s you, and remind other tackling. study; patients large

regulatory through. in countries, place multiple in have and in are multiple each sites. get And contract countries, those we to We

And through. the to personally that up top a hired effort quality We’ve for actually so, following person lead that’s to what we’re clean us effort.

well we’re So, track. on

this covered So, Paresh? we’re Anything start about add that, our it? on else to spring pretty of in the confident I year. Have

Paresh Soni

Yes.

You covered it.

Ron Cooper

Okay.

So, NASH. let’s about then talk

about in excited we’re our IBAT think, I NASH. potential the inhibition of

the I something publications, think think could that liver even but think, problems, transport very appreciated NASH, not when I we in you fully glucose in patients, that NASH in about hallmarks it be liver and comments of think NASH is of is we fibrosis, yet, cholesterol recent bile elevated interesting. inflammation, acids problems,

elobixibat, I patent in into AXXXX. that well-characterized preclinical assets. a as that NASH exposures and method already be it’s for patent of comment. issued We use this over X,XXX in NASH. two-pronged to the So, we my a From taking patent expect drug, perspective Elobixibat, for year the approach, mentioned have

Japan to from maybe talk that So, Paresh, over area. Pharma. rights, and countries you five we’re have patent we have world NASH? for want the except a will as about in all for then, right hopeful the They EA all compounds receive two for And well. of we that in perspective, that elobixibat the other rights

Paresh Soni

Katherine. Thanks Yes.

NASH the elobixibat with mentioned in possibility diarrhea of patients. You

database large a a large efficacy of multiple and in elobixibat. trials. safety have database X,XXX exceeded more We clinical than a we So, patients

a we and And in And safety of doses doses, chronic higher this including constipation. have large So, data goes dose efficacy we the doses right and of Japan. that range quite you can body therapeutic a based a first to at the of is the in very diarrhea range from rate a index of for look -- window you low [ph] with parameters it’s gives think doses with much data efficacy, approved discontinuation and across we therapeutic transient at very get low it starts we’ve elobixibat, that not incidence and high and the diarrhea. when and Also, with the -- diarrhea looked the the few elobixibat. days on

So, when X of we’ve parameters metabolic we studies at and at our that, [ph] LDL look cholesterol also effect showed data including looked good lowering. from Phase

As you incidence improvements cholesterol molecules these also that seen lowering. in sensitivity. know, for improvement [indiscernible] we’ve there is which indicates in And GLP-X, develop

a is us. it’s efficacy think for we good profile of So, and profile the not rationale a elobixibat. have concern safety good We to

adverse Phase like thus a related to and to know keep liver in In that we’ve tolerability good even potent, these as And and efficacy terms AXXXX any of a in elobixibat, again Phase X far and profile is and done. in shown both good a them we’d study spent that looking versus more the study. studies studies pediatric event bit two two the you particularly in of quite which other have molecules, we’ve AXXXX Phase X our profiling molecules, effect, X very diseases time, cholestatic at very

study large other disease. do has X like X is behind work tox NASH because think preclinical a a a NASH into body we less of a for of any pediatric elobixibat, We have can Phase cholestatic we go probably potent safety profile, data a without that better has lot Phase or clinical actually to which for it. work, having good is suited work liver with bit data. So, and profile a

NASH think in So, a will we better that patients. be molecular study

Operator

Thank you.

with Our comes your Alan proceed from Needham next with Carr Company. question & Please questions.

Alan Carr

first comes X might AXXXX, be the taking start I half not being still may Alagille and also out for that what’s biliary that thanks to year? A worked the it And that past this the for as just clarify when it XXXX. be what’s your PFIC to and Phase in Thanks. you NDA need What then, you’ll atresia XXXX? on couple, that Why ‘XX guess, push XXXX, malabsorption point? no from anything for questions. and the opposed submission for happen -- might of needed -- acid my Hi, to and in AXXXX bile else in data might you substantially, else ‘XX. NDA one mentioned might end Last of submission, is, plans

Ron Cooper

Thanks questions, Alan. for your

-- is opportunity of we sure let the I answer prioritization around are first operational of a questions by think, organization there two believe me have question the your excellence. tremendous AXXXX. and We really that making

to And indication as and really we want as that we so -- make get possible. sure quickly first

is the for and enrolled to it going possible. as organization get priority that the as quickly PFIC up and So, trial

Both where going first majority in And to things important are the so, other initiation indication the But that’s that of we to our be secondary resources we’re that spending doing. time. objective. are AXXXX, and are in they

make [Ph] you, indication second or comfortable key a assure we’re study of with starting really of it either right. gated game dialogue a I got add We’ve Alagille having boards. get a opinion in something design, dialogue. else is sure biliary we’re that just the want want the against to leaders. we having a We active so, very being number to atresia, with And

And So, guided sure the ‘XX. to right. it a to for get be start regards same in first thing part then, honest, we of making it about But in the we’ve really AXXXX. is

development are on working We program. the

that -- we the the in on going XXXX. working regulatory And perspective, to we question they’re well. of start to data as The XXXX look trial, AXXXX; we first engage at data. to we that of said the top-line then, we is after to regulators sure to half they making guided we’ve AXXXX get totality trial. the the have And your with PFIC have AXXXX, from up But we guided we’ve will with are what for the need We that for expect the regulators. to end have design the of secondary us there a should a PFIC by regards plan good

XX third So, what’s study, have a at label is will patients -- they’ve going we to study, data is we’ll of long-term open all us the to XX that in the that into approximately which patients we history be important, roll Whatever asked independent so Phase that what X thing they’ll need those the natural data. some have And for generating time, study. support submit. data. is an And observation group,

things those line for should of ready for all on data being be track So, once submission we top have the time. on

Operator

Thank you.

comes Our Cowen Please Baral proceed with Ritu with your next question from question.

Ritu Baral

or do [ph]? PFS in you safety time? you work an then, safety end profile question. for of NASH you elobixibat in of are And Good you and to guys. enough look not would to into structure Thanks X Phase anticipate program, consider morning, your emerging taking to the do straight [indiscernible], patients taking point any wise at On what [ph] a confident do the into biopsy ahead trial first say

Ron Cooper

start second I’ll the comment. think, I with

years profile. signal I And modulators, data team think we’ve think you safety of seen any the elobixibat theoretically in But, mechanism then, both think great clinical history in really we working are if of AXXXX, look that extremely XX if confers about with the our acid I that beauty are profile. been into our general, any non-systemic, sort. the fact they never you bile the safety across has and confident of these the about

a a with have at over elobixibat also long-term we look have exposures. X,XXX year; data we data the with you elobixibat, If over

on things. we’re let it’s still is think that design confident the aspects I shorter progress. But the answer comment work very part, regards to about In that. to of me that in Paresh to safety So, the

Paresh Soni

Yes.

NASH design and We’ve and we’re summarizes group of trial external started that in experts. to to looking elobixibat just think starting talk Ron. thinking I at it, and

it will So, kind what markers biopsy It we kind it, -- or as study whether that’s design a a of decision be not, what still be haven’t will will include it’s obviously [Ph] But likely of [ph] other and made discussion. imaging yet the markers. of the include lot a whether something will under to endpoint.

Ritu Baral

utility [ph] could [ph] would What FX whether stage, better whether is provide paradigm, patients? the on fall this your inclination or current [ph] where patients earlier sort of the mechanism in and

Ron Cooper

Yes.

really that’s think question, I a Ritu. great

the me, I we’re think excited I when leaders, for and their is about talk key me to let us. to comments opinion we what think reflect

us believe that of I are leaders to treatment They key think, there’s there’s medications, across patients, in as have So, general, a of opinion be multiple they’re in being changes something have right? going monotherapy lot else the NASH. to they’re the the excited, things combination that compounds co-morbidities. ability they have in are developed bile And you a mechanism other high a saying either lot are they look them as is will excited So, of the well, or mechanism various pressure, with acid sure, many when the utility fact makes think paradigm on What cholesterol, from them. blood And intrigues that perspective. which non-systemic. I stages overall. going to NASH is They our they’re sense. not medicine general perspective, most modulator on And high diabetes, at exactly pretty use patient look is in in that a they from a the about at

your comment about they’re the that non-systematic, -- earlier plus think key back our safety had leaders, when about that opinion intrigued in fact that the much we’ve So your getting the perceived approach. to profile we talk we’re to we’ve that I data now, very

Operator

Thank you.

proceed your from with Capital Our Rahimi line next Yasmeen with question Please Roth comes question. of Partners. the

Yasmeen Rahimi

different on questions. questions. for on acids and taking that morning Question my thank bile published of effect you NASH. pathogenesis the is one Good recently paper showed [indiscernible] Two that have compositions different

inhibitor So, the of according what the enrollment, on IBAT planning but officially an it [ph] is, in a the don’t clinicaltrials.gov, as with question thought they patients. are has study bile second [ph] process if then although that fact, do acid? started we mid, XXX composition your to And know is changing to given in

of So, taking in of do you given they’re questions. enrollment, of you upcoming any Thank is there study, XXX patients? that if that in believe the completion would next for that potential initiated your delay be to it sort the fact trying that months the enroll with timeline

Ron Cooper

you, Thank questions. appreciate I Yasmeen. your

a lot approach We our have around of excitement NASH. about

elobixibat remind and we’re of AXXXX comments. do trying address and would that getting I goes in right get toward to the it our Paresh, preclinical NASH everybody trial maybe be formative both and you the any that to that used consider Just and could across then as its other work indications. can the is data will stages if year but going But in In general, some we so now that up on. have the what PFIC generate to PFIC in you work

Paresh Soni

So, thanks, Yasmeen.

by excited paper very to and in that see NAFL as which of comes bile acids with actually the thinking NASH. NASH group may actually paper very in much our especially line hypothesis progressing seen you We’re have in Arun role is and Sanyal’s controls, what’s from to of the our to

and acids load in enterohepatic by are You you effectively the bile I see the in as the and greater -- basically and changes in a -- more even of reduce which more telling you designed see bile of blocking you a bile fibrosis, levels the in to bile quantity circulation. acid acids, liver acid the change the is significant see you composition disease in change to the get bet inhibitors severe

with serum our beneficial composition. elobixibat acid controlled XXXX with will designed and a And So, studies, in have changes And releases it shown bile see in to obviously bile posterior we levels. a acid But, needs that both in inhibitors the bile be reductions and in NASH. it actually adequately using in beneficial we well see the acid trial. have effect we that IBAT hypothesis proven using - earlier

obviously. levels liver of NASH. bile measured IBAT of us well inhibition in But, haven’t in terms this for acid the studying bodes rationale We

Operator

question line Our next [Operator Instructions] comes Ed with questions. proceed Please Arce the H.C. from of Wainwright. your with

Ed Arce

the the how a to really probably I program, Hi, this your Thanks bile and an talk the reductions But, for on recent Congrats focus you Ron, to how to and Tom of you progress. before. specifically all this just asked ways and NASH NASH, and of your see taking I of or perhaps effects fit? more good non-systemic mean, I antifibrotic IBAT the elements you. one to you anti-steatosis that the acid drug, wanted been my I around see it’s do focus of had Paresh. direct questions in nature expect see do expect kind around couple see and question the sort to of with co-morbidities But rationale with anti-inflammatory activity. as inhibition understand and you safety. a of on

as directly trying your Thank at the in how you effect NASH. gauge understanding do moment you. see to Just

Ron Cooper

talked facts. full Paresh like clinical I we’ve that I agents. said, look the originally what NASH if think as parameters the back, step obviously you think within NASH. we inhibitors generate want IBAT at share we’d some data of I think -- have to cholesterol, When you But, about, to we as developed and we are what cholesterol with were lowering the

Again issues promising promising with the that GLP-X. data at with improvement shows associated clinic We looks data we elobixibat, NASH of transport. have cholesterol some elobixibat glucose level. some with that in is have an in

And encouraged with by is NASH inflammation so, liver associated and liver fibrosis. that. we’re

some NASH thing, interesting control looks see taken to bile and And last from been effect to that. the we’ve mentioned, perspective, recent has interested and the with then publication STAM in AXXXX data shown model we with have pre-clinically acids mouse that AXXXX NASH on patients the NAFL, that’s patients as into at interesting Paresh levels some Here, increased. with of the

good could that the our go brings data generate to So, interesting us. we in a forward be in need we have in and and that us that’s our hypothesis and NASH plan. that’s into mechanism front That the clinic, and of believe fact that we exciting

Ed Arce

laying out. had was you only That’s X. I Thank helpful. the Phase question other of your initiation planned great. that for around The Okay,

you’re design else just obviously mentioned potential besides a that of the floor with working and start And of But through early method things patent, Thanks. to pending. that you’re on -- You the that the that I if just use is factor it is patent KOLs sort wondering, other different others. aspects was recognize still still of working already said gating there pending as you’ve know trial? I anything

Ron Cooper

I full think is our ahead. So, speed planning

terms We’ve trial with the design. opinion advisors So, interacting key are Paresh retained and of team leaders. in

[ph] NASH, hopeful out. anticipate we’re trying figure patent going So, receive, of in timeframe, that’s confident we’re and going to up that we’re We the occur. we and involved to will it’s method in that this during fairly and receiving of use

what as as occurs of that to line Phase our as and So, should better sight a then we we on trial. execute have would X be, our development able be to planned

shape aware able to as nothing we’re in for from specific. to financial pay there’s perspective, you trial. the a So, else well be good are resourcing as And

Operator

you. Thank

Patrick from next Please question. the with LifeSci comes Capital. your question of Our Dolezal proceed line with

Patrick Dolezal

taking X my for a have on Phase the I do and couple XXXX Thanks Hi. questions. program.

FDA more start, X? we’ve I on And granularity credit prior if measurements bit you’ll if could to using curious just the seen which that be briefly compare So, with you in endpoint? measurements that some provide pruritus just of then, a you Phase for was could the

Ron Cooper

Thanks for the Patrick. question,

talk and you time get Paresh, know, this area you to to want that we’ve that? sure about is As a make it of we an little try maybe right. a spent lot bit that

Paresh Soni

that very this we FDA mentioned, on are quite on input work So, as to closely established it since the which study tool proprietary And we’ve with been and some close pruritus later are and the Ron we PFIC. a we’ve tool guidance experienced while disclosing designed, vendor working a accepted, now, very We a schedule. from developed have hopefully. of that and it’s we and abstracts who tool. a for different to in So, PRO Its shows [Ph] EMA. proprietary decided a AXXXX tool appointed year with a working --

an studies. be they question and And to are used study, understand very proprietary in caregivers. of at of and adult worked easy off patients patients they they we’ll the used and scale. and develop novel the scientific which disclose on tested in pruritus hope using study. children we’ve that a scale, with three the it’s the to to that a we basis X that the and were tool terms more existing And the developed with meeting those used very an we at And which simple out scales we But and look families as and scales upcoming Phase In shelf comfortable it, filling use. their scales; best the it

Ron Cooper

Paresh. you, Thank

Patrick, about for impact FDA insists is on proprietary think in we think on tool. X. tremendous the showed summarize, pruritus this tool Phase I using way to Phase to X, general blunt The a relatively

Thanks As taken that tool excited And caregivers. kids a we’re Paresh pretty that just have will question. X. with Phase that we’ll we’ve in effective and Paresh we And be those of their as I through. details the share more able best the in hopeful of with think as said, our to said, kind that rolls we’re for the you be of year

Patrick Dolezal

have Great, the one similar acid rate. of serum thank you. for I responder endpoint bile then, And a EMA

curios, any such exactly on And seen responder this Just kind how metric be Thank will on acid reductions we’ve then, compares of details bile to the of kind you. again, as you how if defined. provide could obviously rate? the that

Ron Cooper

that for question well. as Thanks

is X X in state, and think The able design thing about lot overall, both we’ll that refined I we we’ve X the FDA when about to been but the what think, for excited think with your Phase both design pretty Phase the the in Phase to pruritus in X to EMA. nice Phase done study again elements acids. almost bile I serum we’ve we’re a more and the question a in about agree of

endpoint in remind difference is treated just to and responder placebo the between group -- So, to bile the everybody primary response acid the for growth. measure the the serum EMA that

expectation of sort that a a we’ve either/or. but If of accounted the is The hard of decrease of variability. in see acids disease, at bile natural response you sort it’s as look of patients to our placebo group, any two sort definition the getting history of during timeframe, for

serum And either XX% a to of of so, would the two. those bile definition. a X back data, XX and one met below XXX, level reaching acids acids go reduction between serum we So, have in bile that patients majority of our or if Phase

Operator

Cooper are any this There to you. to no turn closing Thank I questions the time. would further back remarks. call like for at Mr. over

Ron Cooper

Well, thank you, operator.

got we’ve great think, at to a XXXX I Albireo. start

on executing AXXXX the We’re in thank of their and with And trial excited everybody about for Phase X dialing and rest want interest starting the we our plan. today. for to

Operator

Thank teleconference. concludes you. This today’s

your You a lines and you time. Thank participation may for your at have wonderful day. this disconnect

Albireo Pharma (ALBO) 15 Mar 182017 Q4 Earnings call transcript