Zatsopano Zachifuwa Chosatha mu Idiopathic Pulmonary Fibrosis

Trevi Therapeutics, Inc. lero yalengeza zotsatira zabwino zowunikira pakanthawi ka mayeso a Phase 2 Cough And NALbuphine (CANAL) pa kafukufuku wake wa Haduvio (nalbuphine ER) mu idiopathic pulmonary fibrosis odwala (IPF) omwe akudwala chifuwa chosatha, kutsimikizira umboni wa lingaliro. Kulembetsanso odwala muzoyesererako kuyimitsa kutengera mphamvu ndi kusasinthika kwa deta.

Kampani idasanthula ziwerengero kuti awone mwayi wopambana wa CANAL potengera zomwe zidachitika pakanthawi kochepa. Zotsatira za kuwunikaku zidawonetsa kuti panali mwayi wa 100% wopambana pazomwe zidalipo ndipo Kampani yapita kukayezetsa ndikumaliza kulembetsa ku CANAL. Kusanthula kwakanthawi (N = 26) kunali kofunikira pakuwerengera koyambira kothandiza, kuwonetsa kuchepetsedwa kwa 52% kwa placebo mu kusintha kwa geometric kutanthawuza kusintha kwa zochitika za chifuwa cha masana (p <0.0001, mphamvu yokhazikika 100%) ya Haduvio. Kusanthula kwakanthawi kochepa kunkachitidwa ndi gulu lowerengera lodziyimira palokha malinga ndi zomwe zidanenedwa kale mu protocol.

"Ndife okondwa ndi zotsatira zachipatala komanso zowerengera kwambiri za Haduvio mu mayesero a CANAL komanso kuthekera kochizira chifuwa chachikulu kwa odwala IPF," adatero Dr. Bill Forbes, Chief Development Officer ku Trevi Therapeutics. "Chifuwa chosatha kwa odwala omwe ali ndi IPF ndi vuto lalikulu la matenda osachiritsika opanda chithandizo chovomerezeka. Kutengera zotsatira zazikuluzi komanso kusasinthika kwazomwe zachitika, tikumaliza kulemba anthu mu mayeso a CANAL kuti tiyang'ane kwambiri kufulumizitsa Haduvio mu gawo lotsatira lachitukuko cha chifuwa chachikulu kwa odwala omwe ali ndi IPF. "

"Izi ndi zotsatira zolimbikitsa kwambiri zomwe zimasonyeza kuthekera kwa nalbuphine ER kupititsa patsogolo kwambiri chifuwa chachikulu chofooketsa chomwe nthawi zambiri chimakhudza kwambiri moyo wa odwala ambiri omwe ali ndi IPF," adatero Dr. Toby Maher, MD, Pulofesa wa Zamankhwala ndi Mtsogoleri wa Matenda a Interstitial Lung ku Keck School of Medicine, University of Southern California. "Chifuwa chosatha mu IPF chimakhala chovuta kwambiri chifukwa nthawi zambiri sichimamwa mankhwala oletsa kutupa ndipo nthawi zambiri sichisinthidwa ndi mankhwala omwe amavomerezedwa ndi antifibrotic. Chifuwa chosatha ndi chizindikiro chomwe chimakhudza odwala omwe ali ndi IPF chomwe chimayambitsa kupsinjika maganizo, thupi, ndi maganizo. "

Kuwunika kowonjezereka kowonjezera kuchokera ku data yanthawi yochepa ya CANAL kumathandizira zotsatira zolimba zomwe zikuwonetsedwa pamapeto omaliza. Kuwunika kowonjezerako kunawonetsa kusasinthasintha pamene kufufuzidwa kwa omaliza a nthawi zonse zachipatala mu mapangidwe a crossover, motsutsana ndi nthawi ya chithandizo, ndi chiwerengero choyambirira cha chifuwa. Zotsatira zachiwiri za kusintha kwa zotsatira za odwala zomwe zafotokozedwa zinali zogwirizana ndi kusintha kwa zotsatira zafupipafupi za chifuwa cha masana.

Nalbuphine ER yaloledwa bwino mu mayesero a CANAL ndipo yaphunziridwa mu maphunziro oposa 1,000 paziwonetsero. Mbiri yachitetezo imakhalabe yogwirizana ndi maphunziro am'mbuyomu popanda zizindikiro zatsopano zachitetezo. SAE imodzi idanenedwapo muyeso la CANAL mpaka pano ndipo sanaganizidwe kuti ndi yokhudzana ndi chithandizo.

Kutengera kuwunika kwakanthawi kochepa kwa mayeso a Ph2 CANAL, Trevi watsimikiza kuti asiye kulembera anthu mu mayeso a CANAL ndipo akufuna kuyambitsa zokambirana ndi akuluakulu azaumoyo pankhani ya kafukufuku wotsatira. Kampani ikukonzekera kupereka lipoti la mayeso onse a CANAL kotala lachitatu la 2022 ndipo iphatikiza odwala omwe adalembetsa mu Januwale ndi February chaka chino, omwe tikuyembekeza kuti anthu pafupifupi 40 apezeka.