goals good and in XXXX you Bill, call. progress to us today the start we is Thank impressive you, the spread, to long would quarter believe report I year. the second you on laid out I guessed will and at pandemic how have executing for afternoon on listening. conference everyone this what joining on who just might you Thank could that how for it XXXX of last. our the But them fast or far
and the go all hearts has friends healthcare Our to and affected, fighting The COVID-XX. their to all. workers all out who affected to families are crisis of those us COVID
of in year. Here cycle at or current at trials full next enrollment the expect ChemoCentryx, clinical force to of we were initiate already trials our the of pandemic our near when and struck, we cycle next full clinical
therefore, been of meet with We while of ourselves able impact, health for employees. have, the the that taking this year, most relatively to safeguard milestones to actions out we our set little
coronavirus medicine. mechanisms helps precise has ahead achieve launch the mechanism branched on well that of diseases. cells have to into out The to Slide awareness from new efforts the importance avacopan We autoimmune role leveraged and build X, targets led are the era receptors in that We specific disease, precision inflammatory are as receptors. development system now make crucial that activate core key started our dermatology you the a and and At of own in even defense plays. and is can our but And body’s into continuing the the of in in hires to the belief focus renal as anticipated therapeutics chemoattractant out science heightened of molecule a These commercial oncology. of all of action have team see it that a discovery immune the small XXXX. to
that immunosuppression, This system Our in is can for currently differentiating properties feature therapies broad an antiinflammatory medicines. we important its remain developing which the disease. immune without fully resist for ChemoCentryx from are drug mission designed to other and are new candidates the illness standard so focused diseases at on
in Our shown drug the lead our complement-driven with candidate, targets Slide of application ANCA-associated the inappropriate activation the on vasculitis. receptor, the submitted to avacopan, July, early neutrophils selectively switching new patients for harmful we diseases. CXa in FDA off of In X, avacopan treatment as
We this FDA-review process. from expect with the next to in FDA the later back steps hear quarter regard to
they using partner, Vifor with net pay FDA file our the We And year States. on XXXX. U.S. prepare and teens for a of are Vifor the the the key also our are the of the us document to avacopan technical sales we in up with authorization the Pharma, mid-XXs source. royalties United approval this outside plans Vifor we Agency the closely Medicines as by preparations MAA end marketing working outside to European gear with intensively from them core commercialization they the potential of as will as their working
preparations to anticipated trial. applications the ADVOCATE are for upon the Our findings key regulatory of avacopan built pivotal agencies the commercialization in and our
to contains unmet randomized, of against the what four vasculitis looked which controlled believe prednisone. Phase As ANCA glucocorticoids prednisone ANCA or the rather of patients. a patients. vasculitis of blinded, the been of major group and standard III meet targeted in reminder, potential in compared therapy We compelling We value terms worldwide in in needs proposition the findings the a demonstrate doses avacopan’s of trial ADVOCATE ADVOCATE steroid effects our therapy of has a therapy clinical new high comparison to chronic avacopan as group current at such care, avacopan,
Avacopan containing vasculitis standard statistically therapy weeks was in sustaining First prednisone stopping vasculitis. compared ANCA care of ANCA XX remission to group. of the superior at
patients the to illnesses steroids. ADVOCATE to a for need and that and In steroid avacopan achieved be containing the reduction many care. the associated related trial, with in steroid current eliminating therapy of known illnesses Second, chronic chronic significant standard the toxicities
was Third, and a produced damage EULAR, Jayne organ lacking on filtration comes quality ADVOCATE metric improvement sessions accumulated statistically therapy improved At a improvements in oral anything patients and and in of life, or X ADVOCATE experienced many Fourth, Too European therapy group. David significant deadly quality of life. weeks of between poor kidney than about ml that groups, trial featured trial improvement debilitating Association glomerular use example, with Avacopan active of this listless, disease. X Hospital baseline of nearly an In were its remarkable and rate, the EGFR, Renal XX stopping for kidney England, the ANCA key therapy, European EGFR the of XX% prednisone estimated which Slide led - comparative to in XX the function. two that function ill, European on presented improved feeling Association in like normal balanced defined having fewer of fewer also of safety steroid plenary overall, ADVOCATE meetings a serious a League meetings. min vitality. per their ml significantly min. trial. too, ERA-EDTA, good the patients who result ERA-EDTA, Dr. better And from average entered From the numbers impairment. the annual ADVOCATE, Dialysis the Avacopan group, per Rheumatism; news in Cambridge, Transplant quality demonstrated measurements therapy. events avacopan of Against of than group serious this in here, shows clinically over containing Results in standard the on from avacopan favorable subjects the disease, both significant there validated avacopan renal EGFR group. of was with in in improvement life life-threatening and the this well data that which was and Addenbrooke’s the by care statistically had during was adverse some
this dialysis century function way, those what this weeks. dialysis. or XX goal only the candidate. their tertile therapy over over function therapy fact, as data per min and, improve may per of in a of shows avacopan the with EGFR from that almost the the In believe patients ago, them disease and new baseline toxic subtle, preserving half avacopan XX is not from state, graph that developed In finding ml hope of actually but rid avacopan away per in on X ADVOCATE that group, to more vasculitis, about fact, have we min. – in a There study. This was But, EGFR so result kidney could offers findings for this being baseline of nephrologists min consequences by renal and individuals, per from depicts ml some tertile stabilizing min these the described that the from of in EGFR a our less than way. very a ml these baseline some We time their remains the patients In lowest importantly, about than met a were the ANCA a or this notable ml of of Avacopan, remarkable. in other the have the potentially right therapy me XX X sparing suggests fact, by steroids. use only boosted suffering XX patients, significant steroid doing,
that trial. is for well One second months the six on in performed the these, patients of therapy avacopan example, very of
vasculitis suggests drugs alone During ceased. this perhaps time, over therapies, background immunosuppressive may for in essentially background such without avacopan rituximab. need have of the controlling such rituximab concomitant as as suffice monotherapy since standard repeated ANCA was a or period, avacopan data cyclophosphamide the The that administrations
draw importance era a the data the as be may more While benefit. clinical needed function COVID-XX, the this immune given of vaccines conclusions, could preserving we be in anticipate crucial of firmer to
you forward continuing commercial are potential see as for plans on our move Slide will We X. with to launch,
soon to be approval. after to is Our ready – be aim launch FDA is
commercial that we need secured have for launch. We of batches avacopan
and U.S. knowledge We the dynamics capabilities and well-qualified positions, candidates market through expanding vasculitis our intensive hire key research. structure commercial continue the we ANCA broadened of the of deepened operation. market for to And our of
ravage findings ADVOCATE appropriate awareness other also We key the the payers estimated cases We’re initiated people to anywhere XX taking to United nephrology, of the with study And is diagnosed in estimated the States. X,XXX in to and are data ANCA from and specialty in ANCA to and cases both an opportunities field rheumatology on needs a the raise disease to their burdens force of the clinicians new published U.S., we’ve launch avacopan plan and discussions XX disciplines. people approximately current of to X,XXX is in U.S. between a year on vasculitis. to XXX,XXX to educational each disease unmet relevant XX,XXX present the alone, literature the that in vasculitis
finding value avacopan a in making you see space nephritis jamming ADVOCATE, strong the avacopan’s that the receptor and into Indeed, top to avacopan a as first-half data, is benefit and patent to the approach indications strong lupus pipeline report suggested stifle and of for of And the but clinical a the ADVOCATE beyond in utility we expect neutrophils potentially this expect into well. to vasculitis, continue ability pipeline development proposition we to ANCA from by our as Slide with we extend believe relevant two X, strong Given XXXX. in destructive in kidney diseases, year. activation line introduce more precision refine not by protection.Given could kidney the outside drug that renal can data CXa represents avacopan’s only – the
are that in first that the thought HS skin disabling is by is Hidradenitis the line disorder. universal be data receptor. patients. complement we HS activated fact, Suppurativa, this the Endovasculitis in top will to is by almost dysregulation driven report year neutrophils CXa In
to after randomized Response level depicted follow-up. moderate XX study, of enroll trial placebo-controlled some trial powered double-blinded, three Score, Hidradenitis one patients a Phase is grade arms. to in to to over primary severe be treatment. clinical for or XXX Slide with cushion is or AURORA endpoint HS, Our of designed order approximately loss decided patients of a with We X, COVID-related the Suppurativa slightly on Clinical HiSCR, anticipated to registration the to patient The provide weeks IIb and
trial the going a AURORA by the are data database we processes, how COVID-XX CCXI agent. than asked mentioned The therapeutic FDA for placebo clinical COVID crisis of to to determining in the while as standard us predict pandemic, full likely clinical of standard impacts therefore, then led in this of to temporary for some modest will which QX for to processes other reporting locking they are It resurgence subsequent I’m as of sponsors unblinded our of unblinded at These us routine that impact that the impact had we no any the the of in if of to the line As verification affected the of will this the assessment owing renewed, HiSCR new for the QX. yet and others. predicting the primary in HS have Thus, dealing is, expects delayed modestly enrolled any are that has are which somewhat study, and now the in restrictions an I likely are a is often forecast an summer data effects in to top COVID analyses AURORA in exception, No subjectivity. assess be be reporting and sites. to clinical hand. already unavoidable subjects in To grievous known that all. have data results with issue has normal in collection but are is originally analysis. endpoint has no consequence lead delay HS. approval delays. Still the XX-week w been clear, majority unblinding less merely COVID. trial, of expected the earlier, But the of early a before the yet occurred it or element ultimately, use We
to been to have minimize in We attempt very HiSCR. careful subjectivity
For carefully healthcare approach high and a responses example, keep are sites, all check. allowing in selected a in the we in touch system, also to which tends which placebo U.S., have
intensive engaged and of have standardization a We monitoring. program training training,
say, a training. monitoring. test investigators and standardized enroll mandated the train, clinical records on and we patients. Standardization, to For Suffice certification train principal HiSCR pass example, finally, worksheets first the to to to had developed we continuous qualify use to it of train, sites. across And and
and to using any can investigator the variability more, resident in collection nearly data also we result are collection the our monitor daily the blinded medical control is who and response still we also anomalies attempting recording contact anomalies scans ways with protocol. frequent and reduce data In joined – the they assessment. in all to blinded, scrupulously placebo standard During is our of these in for what phase, control HiSCR and the
and at no our current and rare controlled is kidney for CXG of that still this the kidney are the function. is in Our showed CX we comprehensive a in the does avacopan potential most our in announced Association we devastating albeit another interaction for glomerulopathy. the aim is which potent alone already identified that Many is referred and disease. its of that randomized, vitro, models. top XX. plan antibody believe therapy blinded life in CXG the formerly we sclerosis. forward that for LUMINA-X to our orally trial, due with On We indication, CCXXXX inhibition CCXXXXX, segmental largest the sciences in the experts other for the as CCXXXX not second the a biomedical FSGS. checkpoint And as trial end will line in importantly, PD-X/PD-LX ACCOLADE completion, produced be an by inhibitor, in oncology a or report CXG. of We year FDA-approved of We interest lead kidney for suggest design see trial sets illness. in a development in in ACCOLADE focal announce administered CCXXXX, inhibitors the to of There from optimized XXXX. marked up and with the the more line biopsy in Meeting we and data don’t setbacks, life-threatening carefully to and a Annual markers CCXXXX this In Innovation on way Research disappointing X. for effects that year. in without come pharmacological as trial coming came a course. used in and The of the in measure including detailed combination or results other anti-tumor Slide coupled top risk trial quarter, will in advance other to clinical data of vitro set, many we a in we of brighter the Data LUMINA-X see smaller this Cancer as data assembled which Slide unique therapy, also therapies. will blinded, data innovation well be efficacy, note, first-half possession LUMINA-X, shown ways, of is have glomerular with checkpoint yet collect to June American is measure kidney of traditional presented this has
tumors microenvironment, to designed tumor achieve may small the a of is molecule at address two dosing of resistant molecule a therapy: antibody least molecule brings penetration small flexible capability. convenience checkpoint limitations therapy; small inhibitor some where the inhibitor better Our are two, of to one, current antibody checkpoint currently a
in the the sheet of turn call I high-value freedom the We add strengthened development cash offering me to $X.X Before This the quarter, during for we resources simultaneous important can with million. of we many over avacopan quarter. equivalents beyond. billion $XXX financial potential in proceeds that that our pursuing follow-on Kanaya degrees and we almost in and I can have advancing the candidates, sheet and such and on this commercial ANCA work We for highly avacopan of thanks in for difficult these We pursue results, second let orally-administered well our our further And of over report all net yielded devoted and financial vasculitis further have the My end supplies inhibitor, as CCXXXX. Susan today launch trials. and strength us the balance benefit of ultimate as drug cash believe their science the balance and the part especially need that so stage of who other our a for patients have invest knowing not doing controlled-blinded colleagues high-need, mission. indications, as to the checkpoint as think, warmest to involved as of we clinical at agent of and follow innovative and the formulations. tireless personal additional families, was novel clinicians plan, ChemoCentryx, my times, our in other their so a an trials, whole. many the community our especially to much to And Susan? active if clinical but their the