Ua hoʻolaha ʻo Trevi Therapeutics, Inc. i kēia lā i nā hopena loiloi interim maikaʻi o ka Phase 2 Cough And NALbuphine (CANAL) hoʻāʻo o kāna hoʻokolokolo hoʻokolokolo Haduvio ™ (nalbuphine ER) i nā maʻi maʻi pulmonary fibrosis (IPF) e loaʻa ana i ka maʻi maʻi maʻi, e hoʻokumu ana i ka hōʻoia o ka manaʻo. ʻO ka hoʻomaʻamaʻa hoʻomanawanui hou aʻe i ka hoʻokolokolo e pau ma muli o ka ikaika a me ke kūlike o ka ʻikepili.

Ua alakaʻi ka Hui i kahi hōʻike helu helu no ka loiloi i ka hiki ke kūleʻa o CANAL ma muli o ka ʻikepili manawa. Ua hōʻike ʻia nā hopena o kēlā loiloi he 100% ka manawa o ka kūleʻa i ka ʻikepili i loaʻa a ua neʻe ka Hui e hoʻopau i ka nānā ʻana a hoʻopau i ke kākau inoa ʻana i CANAL. He mea koʻikoʻi ka loiloi interim (N=26) ma ka hopena o ka hopena mua, e hōʻike ana i ka hoʻemi ʻana o 52% placebo i ka hoʻololi ʻana o ka geometric mean pakeneka o nā hanana o ka lā (p<0.0001, mana kūlana 100%) no Haduvio. Ua alakaʻi ʻia ka loiloi manawa e kahi hui helu kūʻokoʻa e like me ka hopena i ʻōlelo mua ʻia ma ka protocol.

"Ua hauʻoli mākou e pili ana i nā hopena koʻikoʻi a me ka helu helu nui o Haduvio i ka hoʻokolokolo CANAL a me ka hiki ke mālama i ka maʻi maʻi maʻi IPF," wahi a Dr. Bill Forbes, Luna Hoʻomohala Nui ma Trevi Therapeutics. "ʻO ka maʻi maʻi maʻi i nā maʻi me ka IPF he hoʻopiʻi koʻikoʻi ia o kahi maʻi maʻi me ka ʻole o nā lāʻau lapaʻau i ʻae ʻia. Ma muli o kēia mau hopena koʻikoʻi a me ka kūlike o ka ʻikepili, ke hoʻopau nei mākou i ka hoʻopaʻa ʻana i ka hoʻokolokolo CANAL e kālele i ka wikiwiki ʻana iā Haduvio i ka pae aʻe o ka hoʻomohala ʻana no ka maʻi maʻi maʻi me IPF.

"He mau hopena hoʻoikaika nui kēia e hōʻike ana i ka hiki o ka nalbuphine ER ke hoʻomaikaʻi nui i ka maʻi maʻi maʻi hoʻonāwaliwali e hoʻopilikia pinepine i ka maikaʻi-o-ola i nā maʻi he nui me ka IPF," wahi a Kauka Toby Maher, MD, Polofesa o ka Lapaʻau a me ka Luna Hoʻokele o Interstitial Lung Disease ma Keck School of Medicine, University of Southern California. "He mea paʻakikī ka maʻi maʻi maʻi i ka IPF no ka mea he pale pinepine ia i nā lāʻau antitussive a ʻaʻole i hoʻololi ʻia e nā anti-fibrotic therapies i kēia manawa. ʻO ka maʻi maʻi he hōʻailona pinepine ia e pili ana i nā poʻe maʻi IPF e hāʻawi i ka pilikia o ka naʻau, ke kino, a me ka noʻonoʻo.

Kākoʻo ka ʻikepili koʻikoʻi koʻikoʻi mai ka ʻikepili interim CANAL i nā hopena ikaika i ʻike ʻia ma ka hopena hopena mua. Ua hōʻike ʻia nā loiloi hoʻohui i ke kūlike i ka wā e nānā ʻia ai no ka hoʻopau ʻana i nā manawa lapaʻau ʻelua i ka hoʻolālā crossover, e kūʻē i ka palena o ka wā lapaʻau, a me ka helu ʻana o ka maʻi kumu. ʻO nā helu hope lua o ka mea maʻi i hōʻike ʻia i nā loli ana o ka hopena i kūlike me ka hoʻomaikaʻi ʻana i nā hopena o ka maʻi maʻi o ke ao.

Ua ʻae maikaʻi ʻia ʻo Nalbuphine ER i ka hoʻokolokolo CANAL a ua aʻo ʻia ma mua o 1,000 mau kumuhana ma nā hōʻailona. Kūlike ka ʻike palekana me nā haʻawina mua me ka ʻole o nā hōʻailona palekana hou. Hoʻokahi SAE i hōʻike ʻia i ka hoʻokolokolo CANAL a hiki i kēia lā a ʻaʻole i manaʻo ʻia he pili i ka lāʻau.

Ma muli o ka loiloi interim maikaʻi no ka hoʻokolokolo Ph2 CANAL, ua hoʻoholo ʻo Trevi e hoʻōki i ka hoʻopiʻi hou ʻana i ka hoʻokolokolo CANAL a hoʻolālā e hoʻomaka i nā kūkākūkā me nā Mana Ola e pili ana i ka noiʻi aʻe. Hoʻolālā ka Hui e hōʻike i ka ʻikepili mai ka hoʻāʻo piha ʻana o CANAL i ka hoʻomaka ʻana o ke kolu o ka makahiki 2022 a e hoʻokomo ʻia nā mea maʻi i kākau ʻia ma Ianuali a me Pepeluali o kēia makahiki, a mākou e manaʻo ai he 40 mau kumuhana.

He aha e lawe ʻia mai kēia ʻatikala:

Based on these significant results and consistency of the data, we are ending recruitment into the CANAL trial to focus on accelerating Haduvio into the next phase of development for chronic cough in patients with IPF.
The Company plans to report data from the full CANAL trial early in the third quarter 2022 and will include the patients enrolled in January and February of this year, which we expect to total approximately 40 subjects.
“We are excited about the clinically and highly statistically significant results of Haduvio in the CANAL trial and the potential to treat chronic cough in IPF patients,”.