Breakthrough Pruritus Therapy Reaches Phase 3 Clinical Endpoint

Hnub tim 22, Cara Therapeutics thiab Vifor Fresenius Medical Care Renal Pharma (VFMCRP) tau tshaj tawm tias Korsuva (CR845 / difelikefalin) kev txhaj tshuaj uas tsim los ntawm Cara yog siv los kho cov neeg mob hemodialysis uas muaj mob hnyav mus rau mob raum ntev - ntsig txog mob pruritus ( CKD - aP) Hauv theem tseem ceeb 3 kev sim KALM - 2, sab saum toj zoo - kab xov xwm tau txais. Korsuva yog kev tiv thaiv peripheral κ opioid receptor agonist. Cara thiab VFMCRP xav tias yuav xa Korsuva & # 39; s Daim Ntawv Thov Yeeb Tshuaj Ntxiv Tshiab (NDA) nyob rau xyoo thib ob ntawm lub xyoo no.

CKD - aP yog qhov kho tsis tau, mob taub hau uas tshwm sim feem ntau hauv cov neeg mob CKD tab tom mob hemodialysis thiab peritoneal lim ntshav. Cov pob khaus kuj tseem tuaj yeem tshwm sim hauv cov neeg mob nyob rau theem III - V CKD uas tsis tau txais kev kho mob lim ntshav. Cov kev tshawb fawb ntev hauv lub tebchaws muaj ntau yam - lub teb chaws tau kwv yees hais tias qhov hnyav ntawm CKD - aP rau cov neeg mob uas xaus - theem mob raum yog li 40%, thiab kwv yees li 25% ntawm cov neeg mob yuav mob hnyav mob pob khaus. Li ntawm 60% - 70% ntawm cov neeg lim ntshav yuav mob pruritus, ntawm li 30% mus rau 40% yog mob nyhav rau tus mob pruritus. Cov kev kho mob tseem ceeb uas tam sim no siv rau cov neeg mob no yog cov tshuaj tiv thaiv kev tiv thaiv kab mob, xws li antihistamines thiab corticosteroids, tab sis lawv tsis muab kev pab zoo ib yam thiab zoo txaus. Ntshav qis mus rau mob khaus heev tuaj yeem cuam tshuam ncaj qha rau tus neeg mob & # 39; s lub neej zoo, xws li kev pw tsaug zog tsis zoo, thiab yuav txawm ua rau muaj kev nyuaj siab.

Korsuva yog qhov kev xaiv zoo tshaj plaws peripheral κ opioid receptor agonist. Korsuva muaj lub zog ua kom loog, anti - voos thiab anti - khaus cov khoom hauv tib neeg thiab tsiaj. Vim tias Korsuva ua haujlwm tsis zoo thaum nkag mus rau cov ntshav - cov nyom lub hlwb, nws muaj tsawg lossis tsis muaj CNS - kev sib kho muaj kev phiv xws li xeev ntuav, ntuav, qaug tshuaj, ua pa nyuaj siab, tsim txom, quav, lossis zoo siab. Qhov kev tshawb nrhiav tshiab no - hauv - kev kho mob tau muab rau pom los ntawm US FDA xyoo 2017.

KALM -2 yog ntau qhov chaw - chaw, xaiv ib qho, ob zaug - qhov muag tsis pom, theem 3 kev soj ntsuam sim nrog chaw tswj chaw. Nws lub hom phiaj txhawm rau tshuaj xyuas kev nyab xeeb thiab ua haujlwm ntawm Korsuva kev txhaj tshuaj hauv kev kho mob ntawm 473 cov neeg mob uas mob hnyav mus rau CKD - aP hemodialysis. Cov ntaub ntawv sim qhia tau pom tias nyob rau 12 lub lim tiam ntawm kev kho mob, 54% ntawm cov neeg mob hauv pawg kho mob tau muaj 24 - teev ib hnub twg khaus khaus digital cov qhab nia teev (WI - NRS) tau ntawm 3 cov ntsiab lus lossis ntau dua, uas tau ua tiav hauv pawg placebo. Qhov feem ntawm cov neeg mob nyob ntawm qib 1 yog 42%, mus txog qhov kawg ntawm kev kawm thaum kawg ntawm kev sim. Ib qho ntxiv, 41% ntawm cov neeg mob hauv pawg kho mob tau txhim kho lawv qhov kev txhim kho WI - NRS cov qhab nia los ntawm 4 cov ntsiab lus lossis ntau dua los ntawm lub hauv paus, thiab tsuas yog 28% ntawm cov neeg mob hauv cov placebo pawg tau mus txog qib no, mus txog qhov tseem ceeb theem nrab qhov kawg ntawm kev sim.

& quot; Peb zoo siab rau qhov zoo tshaj plaws ntawm - cov kab xov xwm tau txais los ntawm Ntu 3 kev sim tshuaj ntawm Korsuva txhaj tshuaj, uas ntxiv pov thawj qhov txiaj ntsig zoo tau los ntawm KALM - 1 sim, & quot; hais tias Dr. Derek Chalmers, Thawj Tswj Hwm thiab Tus Thawj Tuav Haujlwm ntawm Cara Kho: & quot; Cov ntaub ntawv no yuav txhawb peb kom xa cov ntawv thov tshuaj tshiab rau Korsuva txhaj rau US FDA nyob rau lub hlis thib ob ntawm xyoo no, thiab txhawb peb tus khub VFMCRP xa Korsuva & # 39; s daim ntawv tso cai kev lag luam xa mus rau European Medicines Agency (EMA). & quot;