Ua hoʻolaha ʻo Protagonist Therapeutics i kēia lā i nā hopena topline mai ka Phase 2 IDEAL study e loiloi ana i ka PN-943 i nā maʻi me ka maʻi ulcerative colitis (UC).
"ʻOliʻoli mākou i ka ikaika o nā hopena mai ka haʻawina IDEAL a ke kakali nei mākou e hana pū me nā keʻena hoʻoponopono i ko mākou hoʻomākaukau ʻana no kahi papahana hoʻopaʻa inoa Phase 3 no PN-943 i ka maʻi ulcerative colitis haʻahaʻa a koʻikoʻi," wahi a Dinesh V. Patel, Ph.D., Pelekikena a Luna Nui o Protagonist. "ʻO kā mākou waha a me ka puʻu i hoʻopaʻa ʻia i ka alpha-4-beta-7-integrin antagonist agent PN-943 ua hōʻike i ka maikaʻi o ka lāʻau lapaʻau ma ka par me ka lāʻau antibody injectable i ʻae ʻia e hana ana ma o ka pahuhopu ola like. Ke manaʻoʻiʻo nei mākou ʻo nā hopena o ke aʻo ʻana IDEAL hiki ke hoʻololi i ka paradigm a me ka pili ʻepekema ākea i ka hoʻomaopopo ʻana i ka pathogenesis IBD a me ka hoʻomohala ʻana i ka lāʻau lapaʻau i hoʻopaʻa ʻia ma o ke komo ʻana o ke ala integrin-MAdCAM. Ma muli o kona ʻoluʻolu o ka hoʻokele waha a me ka hopena maikaʻi a me nā hopena palekana i ʻike ʻia a hiki i kēia lā, manaʻo mākou he hiki i ka PN-943 ke lilo i lāʻau lapaʻau kumu mua i ka papa no nā poʻe e noho ana me ka ulcerative colitis haʻahaʻa a koʻikoʻi. .”
"Me ke aʻo ʻana IDEAL, ua hōʻike mākou i ka hōʻoia ʻana o ka manaʻo a me ka hōʻoia ʻana no ka mālama ʻana i ka ulcerative colitis ma o ka waha, ka paʻa ʻana o ka ʻōpū o ke ala alpha-4-beta-7-integrin," wahi a Scott Plevy, MD, Hope Pelekikena Nui a me Therapeutic Head of Gastroenterology ma Protagonist. "Ua loiloi ka noiʻi ʻana i ʻelua mau kau o PN-943, 150 mg BID a me 450 mg BID, a hōʻike i kahi hopena hoʻomaʻamaʻa maʻalahi a kūpaʻa ma ka haʻahaʻa 150 mg BID ma waena o nā hopena koʻikoʻi. ʻO ka pane dose i hōʻike ʻia e kēia haʻawina e kūlike me kekahi mau ʻano hana ʻē aʻe i ke ala integrin. ʻO nā mea i loaʻa ma ka lima haʻahaʻa haʻahaʻa e hāʻawi i nā hōʻike kūlike o ka maikaʻi a me ka palekana, a me ke kuhikuhi pololei ʻana i ka regimen dosing no ka papahana hoʻopaʻa inoa Phase 3.
"ʻO ka waha waha, ka ʻāʻī-kaohi ʻia ʻo PN-943 e ʻike i nā hopena like i ka pālua ʻelua o ka lā 150 mg i ka hoʻohālikelike ʻana i ka lāʻau antibody alpha-4-beta-7-integrin injectable a me kāna hana hana," wahi a Bruce Sands , MD, MS, ke Kauka Burrill B. Crohn Kumu o ka Lapaau ma ke Kula Lapaau o Icahn ma Mount Sinai, ka mea noiʻi nui no ka noiʻi IDEAL a me ke kūkākūkā i ka Protagonist. "Aia kahi pono kūpono ʻole a me ka pōmaikaʻi lapaʻau ikaika no nā poʻe maʻi me kahi luna waha e hana ana ma o kahi ʻano hana IBD i hōʻoia ʻia, a ʻo nā hopena haʻawina IDEAL e hāʻawi i ke kumu kūpono no ka neʻe ʻana i ka PN-943 i mua i kahi haʻawina hoʻopaʻa inoa Phase 3."
He aha e lawe ʻia mai kēia ʻatikala:
- “There is a clear unmet need and strong clinical benefit for patients with an oral agent working through such a proven IBD specific mechanism, and the IDEAL study results provide good rationale for moving PN-943 forward in a Phase 3 registrational study.
- “We are delighted with the strength of the results from the IDEAL study and look forward to working with the regulatory agencies as we prepare for a Phase 3 registrational program for PN-943 in moderate-to-severe ulcerative colitis,”.
- Based on its convenience of oral administration and the favorable efficacy and safety results observed to date, we believe that PN-943 has the potential to become a first-in-class, foundational oral medicine for individuals living with moderate-to-severe ulcerative colitis.
