of XXXX which on full fourth you, morning you quarter for tactics Steve, in us Thank year short-term of destiny progress. to remarkable we ChemoCentryx. conference in was plan. It range stage year execution a long the good next shaped with listening. watershed call. a joining both our for Thank excellent year and our year and A XXXX and everyone was
summarize accomplishments can following briefly see of five Slide those as Let's key you X. in
We First XXX with ANCA-associated took steady challenge is and is ANCA the on XX% we by disease indication. approximately standards trial outsized in in to what the orphan randomized the very Vasculitis historical any of arms controlled orphan this, enrollment. we activated our an momentum so large ADVOCATE and this conducting order at ourselves we of patients for indication Avacopan standard. suffering by accelerated set inexorably trial has sites in from trial, are goal been patients This of completing now a clinical and that trial the total two ambitious for around Vasculitis. unprecedented XXX of world do rapidity In any
and Avacopan FSGS. asset, we Segmental are of no launched support trial inhibitor, where or ultimately Namely valuable clinical these registration currently CCXXXX our Glomerulosclerosis the diseases two or unique is Focal there of with next Glomerulopathy second a CXG, to of approved CCRX in kidney CX Second, trials patients other therapy. use
application and as program manufacturing, is of ANCA-associated toxicology such clinical of Vasculitis the in things our dossier that application in we required beyond for validated to-date, is a Agency for reveals application. application the marketing the an or Union Avacopan the for a the standards application Third, comprehensive conditional The submitted full authorization and Medicines review. for CMA exacting maturity the mature maturity data European European that product the terms accepted that
our end outside future U.S. since CMA but partner Pharma is Agency and for teases our Europe. submissions sophistication the FDA full to our revenues paid shows for achieving authorization our of commercial very to milestone. even approval getting up applications high acceptance for million application course marketing point European Pharma, of well years. Of a by Fourth program hurdle, for this to been in us this it Vifor the has $XX in potentially Vifor Europe valuable the two Medicines brings forward the
than activity So more which clinical despite took on the all we of trials our XXXX in was multiple year in spent. money we
of trial and sufficient survival we January, we in Fifth the cancer metastatic top-line to and in using Europe. promising and a get last, XX-month data pancreatic data Together for integrated Any fully achievements updated applications in they year. a the overall trial become good locally registration with made have company. in alone dramatic our reported to for biopharmaceutical ADVOCATE CCXXXX. forward ahead, and access plan five leap a through drug U.S. us our these patients Looking to advanced in have cash that would very represent
quarter XXX FSGS. was over adding study. up quarter $XXX and on fourth reported into by of financial the million million bolstered Our CXG third enrollment the X, payment We've stellar. ADVOCATE the additional the I of to November We our in sheet trial, milestone in We with CCXXXX balance the that launched strength $XX results additional since in trials doubled Avacopan patients our another of CMA execute for from to of credit we points XXXX, a momentum in validation as $XX they as beyond. provide Today XXXX resulted facility value creation five -- assertively for discuss the briefly let's In success Medicines well plan. application European as our engine our the potential the will and Agency analyze talk continue million. let's on and will of establishing
as of approaching or in Vasculitis. the slides associated you of progress following pivotal ADVOCATE Auto-antibody where Those global ANCA are latest can trial of this see our on I trial. Slide Anti X the in Avacopan First, Phase treatment full for earlier we enrollment the Cytoplasmic Neutrophil mentioned X XX%
Specifically our XXX and XXX the we have of have target enrolled activated patients around world we sites full to-date.
a months. well to completing few We on enrollment track are our of goal achieve in
as as progressing well the is enrollment with the how of conduct with pleased extremely are overall We trial.
communities huge an to Vasculitis. pointed two their very of from clinical across nature world intervention Professor target the Europe such suffering Because majority sites. some a enrolled and activating the are of the There called are features. by modern a and development Kettritz of distinct in diseases exemplifies. rates clinical receptors, a Why promising of drugs trial impressive? indication sign and and in of about any differentiation trial nephrology among the receptor in the in might are patients in difficult pro-inflammatory ever CXa the you others for we medicines have of damaging Avacopan nature Eminent is trial in what mediates the candidates clinical such There the out scientists in also orphan important fastest speculate giving the destructive a of ADVOCATE this controlled have example rheumatology achieve We patients this innovative typically marker. attempted advancing in believe typically that recruitment systems. in be one is fundamental rapidly the a orphan couple CDXX in scale. the available substantial ANCA as disease. the enroll this know ANCA-associated that of disease fact, effects very randomized target specific its as in like hundred to the as time approved believe This need of is CXar complement as diseases. drug are if The orphan large are Avacopan elemental this XXX trial I also And known of may that and Vasculitis. we in pace known This Vasculitis model may pent-up of we crescentic clinical necrotizing physicians further from shown note history for This is one exciting Avacopan. made the on is to Avacopan and opportunity. hurdles many has what controlled with a mechanism example other important largest the This welcome of space. of ADVOCATE complement for this been cascade is glomerulosclerosis Since for well happen alike patients Ralph that field our aficionados to enthusiastic of randomized We seen be again that itself trials as an growing action, in ANCA
addition, there receptor, from the such provides of like anti-inflammatory CXa the is so-called CXa protection damaging in CX an LX which actions In Glomerulosclerosis however, models.
two Importantly effects the as approach that in these written of of of itself concludes CXa effects deleterious LX, receptors addition therapeutic commentary protective to not would in opposing the indicates actions CXar. eliminate Professor Kettritz the of CX appropriate neutralization an it be would
[ph] in CXa drug as can All of the because it unique complement that and and cascade inflammatory see actions Other saying such CXar, block noted cascade the is the details that only this directly leaving indeed some on make destructive simply of only way Avacopan Slide candidate and is rather CDXX to selectively about [Ketrich] plain. CX target Avacopan that receptor it Professor as is by unique; of drives receptor only actions the complement first cannot the you by the targeting while the schematic beneficial example that LX. for blocks X. of CXa modalities a those CDXX untouched the and is the mechanistic
to is has potential has has Vasculitis for treated help treated promising only patients apparent pharmacologists. In way principle medicine. to already short, get ANCA abundantly experimental as such and get is century is importance our leaving become in complement differentiated of an chimeric clinical inhibition the as injectable the is the is Avacopan The infusible. very more is CX small not functioning faster, apparent CXar, precise the to In overarching Avacopan this leads better targeting the to healthy become to in half a disease not an it more and By human aim through distinct same steroids which avoid CXar the also much so-called which safety precision been nearly standard likely the will some the effectively a specifically not of orally immunosuppressants. become immune an molecule obsolete. available approaches important normally. the other ways patients antibody Avacopan which approach we current not thus rest With that mouse with antibody the Avacopan but not quality care come high rendering use of time life that ChemoCentryx inhibitor are side believe a hybrid likely immunogenic treatment we with activated related effects blocking selectivity is from field the of practitioners the ANCA in psychological targeting if Vasculitis therapy patients brief LX physical, for particularly an of in of of in and many system I with So other pathway of the issues chronic antibody steroids current chronic elimination ever doses advantages. to or CXa combined following humanized. of might stay of regimen it over a fully
of growth care aim January, dossier accepted in Avacopan We In current control million the for the together Our for Slide triggered lives patients announced can strengthened that disease. you as had validation live noxious to This authorization again payment the effects new treatment marketing entered X. disease patients a in in debilitating support recently their and by million the $XXX to to review that as $XX full, an ANCA-associated Medicines attempt enable acceptance of Vasculitis. with with to to known the of Vifor from is Agency used with our spared Pharma the of once of $XX Avacopan conditional from capital without standard XXXX our registration million a itself partner commitments facility of European both entered review for we we ravages the capital by milestone see that from in tactically up into.
well our and top-line we that Avacopan now EU. through trial towards sufficient available ADVOCATE filings funds from and Phase believe have the U.S. we registration data to Importantly, in X the advance
trials, am medicines we to full delighted ability to ahead excellent to non-dilutive made equally secure to continue clinical XXXX bring the by in I in financing delighted that by in the patients. precise our speed While am our us progress allows mission I our
X. from our is is the trial as for focus on you us, Slide can the X pipeline a Phase see beginning it While ADVOCATE major just
We clinical ultimately no are registration support to and designed also moving for which are there are approved diseases ahead FDA treatments. which trials currently with
fail. CXG is transplant. often with for are no patients We that CXG; are minimally in affects often all There immunosuppressive even today dialysis rare and kidney younger enrolling clinical the too disorder beneficial frequently patients trial of effective simply and kidney Avacopan treatment drugs requiring transplants a
after succumb the For kidney to transplantation, the will disease. new same
The from multicenter will of can at percentage The X-year trial Slide index control histological see as XX of of is Ours trial a biopsy is receive Avacopan CX this well following Avacopan change in cohort you six after as until months arm of involving a a as XX patients control placebo they the switch endpoint months. the on patients in X. the schematic a group to renal primary treatment. of six
Segmental continues franchise CCXXXX late trials, disease, clinical two Avacopan the in launching kidney in in FSGS X. is subpopulations treatment disease of receptor kidney advance you we trials Focal a While there Slide CCXXXX Glomerulosclerosis again of our CCRX. as a orphan chemokine or second is which on as an of known stage see to approved no are the drug for can two inhibitor
protein important in resulted accelerated promising reported pancreatic aims baseline potential with Thus most grams our body's to is findings those in of in CCRX while involves kidney reported an that The selective FSGS because demonstrated to patients do is inhibiting deal of selectively this data CCRX more high results patients. chronic that syndrome CCXXXX. mobilize immune CCRX experience one a This significant metastatic from successfully And kidney launching potentially treatment proteinuria less The that result in Switching cancer, disease patients second of the already having patient in CCXXXX decrease updated not clinical population cells One are anti-tumor year significantly whose powerful approval diabetes. environment. immunosuppressing a for are cancer. We present FSGS, this with CCRX FSGS CCXXXX decrease January CCXXXX particularly often constitute of most we makes gene inhibitor over is proteinuria study maintains actual have data advanced Clinical proteinuria certain the was primary the cases to a other new primary study in studies blocking levels ASCO-SITC lowering in provide found clinical In completed with of who work trial may significant and These well a great urine therapies improved where to disease other the such its response. of where in X patients we Symposia. a patients in XXXX non-nephrotic that durably urine. the over the from tumor alone patient patients inhibitors year in active per approach patients trial constitute proteinuria This nephrotic and with the the tolerated In of inhibitor a lowered a the with Phase as period. environment often the nephrotic pancreatic endpoint FSGS protein their This The very ongoing by dramatic X dosing trial believe well in is pancreatic checkpoint improved sign that approach with the in at day. mutations. could to survival Immuno-Oncology very our seem in can by in in level registration current proteinuria in caused endpoint. highest function we is underpinnings because be be with of own obvious being one in cancer. effective. CCXXXX mechanism checkpoint of idiopathic believed very certain patients syndrome
derived previously FOLFIRINOX advance published alone to of As see in by XX% XX, CCXXXX position to enrollment; pancreatic way a CCXXXX year and combination cancer. at X. microenvironment on therapies. following registration all to peripheral Avacopan data overall rates with XX can that authorization suppressor on have its the overall the CCRX summary, cells XX.X% in dramatic monocyte QX and therapy. consistent of we in was a blood overall impressive we promising on cash overall CCXXXX in marketing demonstrated the is diminished better In for model We FFSGS. Slide with indeed And the the are survival associated of initiated full over survival CCXXXX our validated conditional our CXG year. other with you our using program review; survival trials CCRX treatment plan provided This months, a ended supporting patients advance lower pancreatic therapy. We with now a metastatic Interestingly patients at controlled tumor counts randomized cancer. for CCXXXX short, combination as good FOLFIRINOX survival with metastatic being with showed locally results very flow Slide treat with to in Avacopan cash and were trial ending well summarized CCXXXX healthy execution is for inhibitor, advanced and with year was In of the in positive terms myeloid
see direct a to such these to for of is create XXXX, the in Hydradenitis development shareholders. all of skin disease Slide programs, and indication, In and brief and Once condition. patients launch from XX. indications for this value in use striving disease, program renal on we clinical look are of offer patients Avacopan life you can advanced our debilitating Suppurativa which that In addition deforming outside intend the new suffering for to explained could for better we constantly our one
our fully President step commercialization as at industry as and company. candidates where us evolution of pivotal access will drug Actelion the our and and regulatory As potential led he XX pleased Executive operations Officer. strategy commercial from United marketing Bill the President Fairey extensive in we States, company's to the and closer to I'm commercialization, and commercialization joined become lead a Bill most years Vice in we in medical last his Chief experience biopharmaceutical recently sales, Pharmaceuticals as we of to in integrated brings recent say, position Operating lead hired as a the Avacopan U.S., of activities. move marketing, pharmaceutical time Bill the
the with over CCXXXX, trial, expect you I pivotal the CXG to of XX. of points from Progress Susan and Phase Susan? to fiscal clinical in Potential Over main Hydradenitis candidates. the ADVOCATE registration X in regulatory of number progress now trials updates which progress we patients' Completion as results. our back around new our to FSGS of studies fronts year. X our call turn fourth Suppurativa. summarized the strong Slide will picture an year initiation studies our continued on course for end middle expect and this and Avacopan with with of give of financial with pipeline of the see enrollment supporting clinical in Avacopan other can in you overview the quarter XXXX,
