its XXXX. the the all detail met for in of Thank you, We end the that am expected we that the previously the press we greater generated XXXE us and joining results reported Earlier today of of pleased a and of have primary now and issued first report concerning points. secondary our extension design and trials. half provides we in the I to that thank it trial the trial results data all today. that release Jackie, you
you saw walk fact TRCXXX blood on surprising the to expected upside the want of safety surrogate highlight long-term effect I the results endpoint. that Before durability I bicarbonate a through good profile and we of the beyond
XXXE metabolic XX in subjects trial week Following mortality, all in subjects the These function. in elected trials XXX of observations XXX TRCXXX and CKD have placebo physical non-dialysis were was acidosis reduced bones, underlying TRCXXX with randomized the treatment health. dependent blinded with kidney and XX improved acidosis. of week weeks including and evidence of in patients XXX the to line and XXX the CKD The are we slowing muscles, trial. which of extension patho-physiology cause extension and impact benefit continue and in observed subjects of consisting clinical group of a XX subjects treated qualified progression, on its metabolic XX
we the events, that events We placebo. adverse TRCXXX safety TRCXXX. fewer endpoint profile was rate primary The on fact fewer XXXE observed observed the with a placebo. discontinuations, of versus of GI a the TRCXXX start of me Let serious profile safety assessment adverse of comparable clean long-term trial for and versus
durability milligrams of week occurred adverse the placebo. an X.X level and have [fear] subjects no increase P prematurely. XX.X% events of adverse of effect four placebo in of of exhibited achieved with patients. versus placebo blood the change adverse to [ph]. X.X% placebo in bicarbonate TRCXXX [ph] to baselines milligrams treated XX% compared level subjects treatment in That's evaluated discontinued serious completed blood was a with versus active said to assessed by incidence per and mean increased of were of might endpoints serious treated treated and function. The X.X% TRCXXX X.X and We group period. be Gastrointestinal treatment litre in X.XXXX. blood in drug] group The group observed representing of of bicarbonate of range least TSCXXX normal the in The or group in treatment the and to the at final active value the group a affect who between X.X% milligrams active XX changes from the of end TRCXXX blood liter per secondary the sustained related X.XXXX. in of the events bicarbonate X.X% in in blood subjects bicarbonate the the Specifically two TRCXXX XX% value per placebo how events patients Two TSCXXX XX.X% subjects. placebo patients of on secondary comparing bicarbonate X a was endpoints in represented in litre patients P how compared [study
chair If function physiology mass and indirectly you to of directly the responses to self-appointed function with and was test. can muscle KDQL basic assessed recall contribute measured acid physical physical metabolic impaired the up acidosis build a a stand survey reduced through behind functions. repeated Physical
effects these thresholds from and believe favor the both the minimally in placebo literature. adjusted in the X.XXXX the Survey reported Physical were a two stand P chair to with week highly TRCXXX at results KDQL Let week [indiscernible] improvements test provide compared XX. subjects of scientific me We approximately placebo adjusted both important observed the and function XX of significant results treated improvement Functioning repeated statistically return evidence difference of doubled at exceeds the physical - value the clinically function physical the in in less and
eGFR. really results most get trial. this I exciting of deals As and you tell clinical greater endpoint all included that of We event. comparison can to this with mortality, DDXX the can't placebo dialysis, referred a pre-specified or wait one to of this to the as in composites a next the XX% TRCXXX unexpected groups time of and part decline for We cause the equal to
in DDXX XX% This four the subject the in There of a rate TRCXXX group combined value the X.XXXX. in annualized patients and initiate died. XX were represents group. X.X% plus P was Over week dialysis. incidence deaths group no one statistically placebo the placebo significant group period treatment had TRCXXX Each the
the trials group. CKD annualized in XX% Although treated designed not powered TRCXXX a DDXX assess or of the the XXX, event observed progression cause rate mortality XXXE reduction the we clinical or nevertheless were placebo all outcomes for versus subjects to
in accelerated we far bicarbonate We exceeded our week TRCXXX observe extension confirmatory our committed beyond evidence any anticipate did second that our combined results our VALOR-CKD XX an up on blood we until the INDA The readout at of somewhere post-marketing So look to where with top not of the time half patients program XXXX the post-marketing sum to in in the expectations. let We are based trial remain to trial. the submitting treated of me benefits results the of of line in XXXX trials. would VALOR-CKD frame. clinical approval increase XXXX analysis forward and
and increasing we've not VALOR-CKD trial learned the do any the safety efficacy, trials. confidence size feel what design our successful study of regarding While about for we in good to we the VALOR-CKD XXXE or change anticipate
primary time event will have we as following be events of will to study. followed accrued The Just until target subjects reminder which approximately full four a is trial number we the the years enrolment. be a endpoint ongoing VALOR-CKD estimate
primary specifies size protocol in of assumption interim an accrued efficacy, may Our At renal the we at half trial point of increased time changes. the end on two when sample based sample stopped size to XX% to have XXXX meds. been be be or full the after was the the least for Furthermore estimate number reduction such subjects events may of continue the a years trial which early be planned XX% approximately may will analysis without three enrolment.
successfully of We prior the programs. clinical FDAs that all accelerated trials to we to approval our through plan complete completed of have the NDA submission now
track for submission We the second XXXX. of in are the on half
trial Next I beyond a community. Tricida like in would Mathur. thank opinion publication like is in Tricida our journals. our metabolic Dr. TRCXXX and I leading to authors nephrology the medical interest journal Lancet, shows The independent extends clinical leaders results for This milestone important to an Phase that of of Wesson, Tangri, our the and highlight acidosis and would X Bushinsky,
update provide like an to our on DDI Now I'd studies.
[indiscernible] drug-drug the determined studies guided interaction underlying vitro TRCXXX, and warafin appropriate Our separation X clinical DDI studies we trials evaluate and the interactions in our recommend furosemide, effects. to not in to need by co-administered was for mechanism with FDA action DDI studies for aspirin, it Phase we TRCXXX. was of Based of we results any drugs on do our believe of dosing potential and
pleased of including Susannah strategy roles and how to industry say and running. me at strategic let ground and us Genentech she Susannah Chief hit at and successful Gilead, launched to depth Susannah Genentech-Roche, comes Geoff to over senior am the call GSK. Officer. and the commercial as operational and across turn brings Tricida welcome Gilead marketing, has and Tricida of I the level executive over therapeutic our already with products multiple Before to XX global operations, experience years and breadth commercial has sales, Commercial I to experience Cantrell
physician and are during activities patient pre-launch analysis, the economics including activities, analysis, market managed logistics, surveys, Our healthcare operational more. underway refined much
the the team. Hercules update cash And have as I'll to provide which for new also Geoff and to our we delighted guidance truly discuss amendment to pleased XXXX. morning a are announce join now We with were to you Susannah well as this financial ask