Protagonist Therapeutics kajeno e phatlalalitse liphetho tsa mantlha tsa thuto ea Phase 2 IDEAL e hlahlobang PN-943 ho bakuli ba nang le lefu la ho ruruha ha ulcerative ho isa ho le matla (UC).
"Re thabetse matla a liphello tse tsoang thutong ea IDEAL 'me re lebeletse ho sebetsa le mekhatlo ea tsamaiso ha re ntse re itokisetsa lenaneo la ho ngolisa Phase 3 bakeng sa PN-943 ka lefu la ho ruruha ha ulcerative ho isa ho le matla," ho boletse Dinesh V. Patel, Ph.D., Mopresidente le Ofisiri e ka Sehloohong ea Phethahatso ea Moemphera. "Mohanyetsi oa rona oa molomo, o thibelang mala oa alpha-4-beta-7-integrin PN-943 o bonts'itse katleho ea bongaka ha e bapisoa le setlhare sa antibody se lumelletsoeng se sebetsang ka sepheo se tšoanang sa likokoana-hloko. Re lumela hore liphetho tsa boithuto ba IDEAL e ka ba phetoho ea maikutlo le tsa bohlokoa bo pharaletseng ba saense ho utloisisa IBD pathogenesis le nts'etsopele ea lithethefatsi tse thibetsoeng ka maleng ka ho kenella ha tsela ea integrin-MAdCAM. Ho ipapisitsoe le boiketlo ba eona ba tsamaiso ea molomo le katleho e ntle le liphetho tsa ts'ireletso tse hlokometsoeng ho fihlela joale, re lumela hore PN-943 e na le monyetla oa ho ba moriana oa mantlha oa molomo bakeng sa batho ba nang le lefu la ho ruruha ha ulcerative ho isa ho se matla. .”
"Ka boithuto ba IDEAL, re bonts'itse bopaki ba kliniki le netefatso bakeng sa kalafo e ka bang teng ea lefu la ho ruruha ha ulcerative ka molomo, thibelo e thibelang mala ea tsela ea alpha-4-beta-7-integrin," ho boletse Scott Plevy, MD. Motlatsi oa Motlatsi oa Phethahatso le Hlooho ea Phekolo ea Gastroenterology ho Protagonist. "Phuputso e ile ea hlahloba litekanyetso tse peli tsa PN-943, 150 mg BID le 450 mg BID, 'me ea bontša phello e hlakileng le e tsitsitseng ea phekolo boemong bo tlaase ba 150 mg BID ho pholletsa le lintlha tsa bohlokoa. Karabelo ea lethal dose e bontšitsoeng ke phuputso ena e lumellana le mekhoa e meng e mengata tseleng ea integrin. Liphuputso tsa letsoho la tekanyo e tlase li fana ka bopaki bo tsitsitseng ba ts'ireletso le ts'ireletso ea bongaka, le tataiso e hlakileng mabapi le mokhoa oa ho noa bakeng sa lenaneo la ngoliso la Phase 3. "
"Sethethefatsi sa molomo, se thibetsoeng ka maleng PN-943 se bonahala se na le litlamorao tse ts'oanang ka tekanyetso ea 150 mg habeli ka letsatsi ha se bapisoa le sethethefatsi sa antibody sa alpha-4-beta-7-integrin se lumelletsoeng le mokhoa oa sona oa ts'ebetso," ho boletse Bruce Sands. , MD, MS, Dr. Burrill B. Crohn Moprofesa oa Bongaka Sekolong sa Meriana sa Icahn Thabeng ea Sinai, mofuputsi ea ka sehloohong oa thuto ea IDEAL le moeletsi oa Protagonist. "Ho na le tlhoko e hlakileng e sa fihlelleheng le melemo e matla ea kliniki bakeng sa bakuli ba nang le moemeli oa molomo ea sebetsang ka mokhoa o joalo o netefalitsoeng oa IBD, 'me liphetho tsa IDEAL li fana ka mabaka a utloahalang a ho ntšetsa pele PN-943 thutong ea ngoliso ea Mokhahlelo oa 3."
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- “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.
