everybody Thank you, afternoon Jack. Good today. and for joining us thanks
in topline and culminated KORSUVA quarter announced X our first patients positive trial ways ago. many KALM-X recent in hemodialysis weeks our few in from we So, which injection progress a to global of Phase data
continue of to sustained U.S. our Phase Injection patients observe that in We to first consistent trial a we our were robust very trial. antipruritic be observed pleased KALM-X KORSUVA and was with what effect in X these
With we're to track that indeed we from remain a on Phase and of ready in submit both this positive NDA second results database our efficacy and to on our now trials the go, hand X safety in focused large preparing year. half
delivering period. on, time Before the data entire during to team on for we go such commend I'd this Cara a like set challenging
has order our pandemic flexibility development commercial time to and advance lines. evolved, our in preparations team demonstrate programs our dedication to COVID-XX the great has As in with and continued keeping clinical original our
result pandemic, minimize we our several a and and employees and the safety health patients operational investigators potential study our of measures clinical studies. ongoing to As the and to to prioritize, disruptions of have implemented
I remote in clinical ongoing our enrollment that, for source studies, And SOPs pandemic. monitoring our These document been clinical adopting include such visits. affected has verification, of to in will other measures, many for trials. rate the as somewhat, the remote companies like note response
fortunate. open However, are And study and enrolling remain sites almost patients. of are all our we
clinical we will should projected remain, you, to of these expected And update changes, be any on course, track. moments. lines continue Our time there to
KORSUVA. Injection KORSUVA clinical and we do Lastly, both supply of Oral sufficient have
or We with continue are commercial our and clinical will in contact minimal no future And manufacturing partners. we that supply close believe disruption. with
adapt federal in team the Cara and business the can government, We're pandemic. And from operations very progression working the appropriate. that a quickly is setting. efficiently, guidelines be side of monitor state should our operation virtual continuing to so overall the we On to
on So, broad blocking modalities of on first expectations rest in contrast year. our of to to for provide action, of I one and focus But other our each antipruritic I'll mechanism is an the reminder, on a specific this KORSUVA's quick programs which update wanted today's call, pruritogen. to provide on
pruritogens. action the on stimulation fibers diminishes cells, and And dermal epidermal of stands from release of So immune or KORSUVA stream dermal a the pruritogens. KORSUVA all nerve-sensitizing molecules directly action sensory fibers blocks range of the C of the the or of of
disease, inflammatory of if liver we is of for activity, anti disease whether what some chronic or antipruritic initiating effect, kidney dual, And condition. that regardless type dermatological this that's neuronal believe the or and chronic provides pathophysiology
KORSUVA begin with is CKD let's approximately associated patients, of severe a So patient moderate pruritus. with XX% to patients where injection our population This from for hemodialysis lead XX% in suffer to program pruritus.
So significant currently unmet no therapies a or with in in the clear U.S. need Europe. approved
top line efficacy and that safety to global our presently versus Our last two Both Injection, four And line kilo placebo, Phase read three times positive a administered pivotal which KALM-X the of trial, efficacy concluding. were dose trial, read program a top and week. KALM-X efficacy micrograms investigate data positive year, includes, at designed trials. per per last is KORSUVA KALM-X studies, data out U.S. a month, which open-label KALM-X of III X.X
trial treatment safety. included phase a by scheduled And XX-week XX-week each for successions, a open-label extension after that's efficacy So period. over
in to April, of positive XX% significantly were with very In achieving group. Injection reduced improvement itch top KORSUVA a the at demonstrated the report mentioned, endpoint, Analysis already that pleased of subjects intensity, placebo to three-point I've itch we intensity line in of worst as least XX% primary subjects KALM-X results. compared
As KORSUVA group. improvement compared subjects in XX% more such four-point endpoint, to achieved treated and of the for itch a secondary with placebo least intensity XX% at the key
as reduced. additional significantly we And domains indicate the scales related of self-assessment results by statistical of quality although these two our didn't significance did that X-D achieve etching Skindex-XX both the itch and skills, on analysis life measured in intensity were endpoints
a both was that KALM-X primary trials in consistent in clinical the generally Injection reported we and safety key improvement well-tolerated profile KORSUVA endpoints. with our the with prior and consistent that's program. secondary So with this with was
or have safety over and for more database including therapeutic treatment exposures the total a in to patients XXX submission dose. months safety ICH treatment X,XXX patient with We NDA on program. patients Moving line completed indeed an than XXX over our a six as having of year studies exceeding currently guidelines completed in one of
So we cement second in the have exposures safety support to half NDA to to well the are of package positioned We the believe confident FDA strong we we're NDA sufficient submission. a year. our
may indication, we have recall, for also this be KORSUVA for we'll Injection you so As priority applying designation breakthrough for review.
commercialize U.S. established commercial to including European and license the and we've commercial and As the you Union. other know in Injection we already agreements plan major markets Korea KORSUVA Japan,
us In Fresenius, to with dialysis for to the the marketing of at we EU, Fresenius EMA NDA Fresenius, to we authorization submit which complete with leverage shortly Vifor collaboration across we allows broad reach approval, after plan partners that the Vifor continent. patients have a submission. our Working the
established build and a agreement hope we've specifically us U.S., Fresenius which which profit upon the and Vifor within and allows both neurology-focused KORSUVA clinics, the will Injection with we sharing adoption momentum of to Fresenius for Vifor, Fresenius co-promotion expertise the In launch. of leverage
we've cross-functional through increase disease awareness established hard associated We established preparations, at launch of and the pruritus MSL Group continue they've been national already of CKD on a to and education. plan. terms Cara our In to commercial execute our working
all planning our to as necessary of for launch begun XXXX commercial that, and market laying manufacturing to the Beyond we've post-NDA that groundwork steps hires, and KORSUVA sales sales as senior in the includes well prepare marketing, potentially establishing Injection agreements for activation approval. force access,
continue results KALM-X commercial So update working for on is are NDA the we'll extremely package and Cara we later in again very year. with you timing enabling this that on our and for And finalizing the quarters. hard the pleased submission coming our preparation NDA to team
Oral and on forward we that tablet X our safety So our and X daily. let's trial the strengths tablet on the data, pruritus. our of from year, mg results efficacy with program Phase positive pre-dialysis XX-week we identified to once KORSUVA December patients Based strength severe the on X.XX, take Phase to X.X level CKD with moderate focused evaluating program reported to three III. lead taken and dose in Oral II In of topline last into as pipeline move start KORSUVA, mg
proportion approximately seven some effectively alleviate the one-third sort typically with neither receiving treatment population, here reflects CKD pruritus about treatments as hemodialysis currently the of term. drug CKD the are in not people with burden pruritus generic significant pre-dialysis which patients. long of these of And diagnosed Based a in And or certainly pruritus. antihistamines are million the of data on prescription U.S., the pruritus-related corticosteroids for
here program population that a meeting enable So initiation as therapeutic keen end second With significant do to hold possible. that to move for II KORSUVA as in we to plan as half our a the mind, as with in the to registration an novel opportunity in and we're Phase soon that Oral program. year of FDA III this of approach Phase pivotal of
diseases moderate ongoing approximately of currently XX% AD CKD-associated disease chronic children. or point across you atopic And with rates pruritus, patient XXX%. Pruritus PBC. for atopic Cholangitis the in or topical prevalence KORSUVA essentially to X% II the then Oral is corticosteroids a a in fashion symptom As Primary inflammatory area of Phase fall particularly many at treatments of short is of the and we're common know, of hypos estimated spectrum antidepressants. prevalence Biliary with and and dermatitis trials also the the of mild dermatitis antihistamines defining most evaluating course adults dermatitis in similar Atopic one consisting drug
we conducted II taken incorporated conditional assessment patients approximately We three adjustments of strength X.X size number the severe patient atopic with ongoing KORSUVA, to randomize trial from to interim mg targeted of placebo. daily complete enrollment approximately XXX versus the And twice XX-week year, the design is of we Oral pruritus XX% an and designed this and adult XXX January two to across again, moderate trial. this dermatitis that treatment designated after In be our Phase So expanded patients. period. to power to X.XX, patients tablet made X
that, in I'm to next the statistical the number the of And happy analysis on end track we're complete interim second of this before report weeks to quarter.
experiencing with with patients but patients in prevalence severe Pruritus with patients pruritus. common is also our to a pruritus, diseases of to with II with cholestatic XX% liver PBC trial PBC. in Oral up a moderate of symptom We of XX% to KORSUVA continue Phase XX% of
of trial a X value as patients. a strength reminder in twice mg tablet of XX safety daily a is efficacy So present approximately this Oral placebo KORSUVA, taken XX-week versus
the with that of the enroll data two slowed somewhat has patients before to to we're clinical nearly expanding Phase although trials all aim to We're enrollment due II of year-end. sites continue rate our remain we trials sites open also as like study able I'd and for both add report to from these the pandemic.
So submit up, on is first to trial. year. very compelling off a Injection our track consistent this KORSUVA wrap XXXX our with NDA to later for We're data to from KALM-X start good
addition, and dialysis CKD to pre progress Phase the of In modality KORSUVA, II PBC. dermatitis major we our with oral data in III finalize both as the trials and we for work program Phase expect patients readout and atopic
it to I'll that quarter. the for turn with So results Rick? to Rick financial over cover the
