Phunziro Latsopano la Pivotal Phase 3 la insulin yapakamwa

KUGWIRITSA KWAULERE | eTurboNews | | eTN
Written by Linda Hohnholz

Oramed Pharmaceuticals Inc. lero yalengeza kuti yamaliza kulembetsa odwala pa kafukufuku wake wa Phase 3 ORA-D-013-1 wa oral insulin capsule ORMD-0801 yochiza matenda amtundu wa 2 (T2D), kupitilira cholinga chake cha odwala 675 omwe ali ndi 710. odwala analembetsa.             

ORA-D-013-1 ndiye wamkulu mwa maphunziro awiri a Oramed Phase 3 omwe akuchitidwa pansi pa US Food and Drug Administration (FDA) zovomerezeka zochizira odwala T2D omwe ali ndi vuto lowongolera glycemic kwa miyezi 6 mpaka 12. Deta yogwira ntchito ya ORA-D-013-1 ipezeka odwala onse akamaliza chithandizo cha miyezi isanu ndi umodzi yoyamba.

"Ndife okondwa kulengeza kuti kafukufuku woyamba wapadziko lonse wa Phase 3 wa insulin yapakamwa, wochitidwa motsatira ndondomeko ya FDA, akwaniritsa zofunikira kwambiri pakumaliza kulembetsa. Kutsatira chithandizo cha miyezi isanu ndi umodzi ya wodwalayo, tikuyembekeza kulengeza zotsatira zabwino kwambiri mu Januware 2023, "atero a Nadav Kidron, CEO wa Oramed. "Ndife okondwa kwambiri ndi mwayi wosankha insulin yapakamwa kwa anthu omwe ali ndi matenda ashuga. Ikaperekedwa pakamwa, insulini yapakamwa imatsanzira malamulo amtundu wa insulini isanafike m'magazi, kupereka kuwongolera bwino kwa shuga m'magazi komanso kuchepetsa ziwopsezo ndi zovuta zomwe zimagwirizanitsidwa ndi jakisoni wa insulin, kuphatikiza kunenepa ndi hypoglycemia, komanso kukhala kosavuta kupereka. Ndikufuna kuthokoza odwala onse, ofufuza komanso ogwira nawo ntchito omwe adachita nawo kafukufukuyu, onse ndi cholinga chimodzi chothandizira chithandizo cha matenda a shuga. "

ZOMWE MUNGACHITE PA NKHANIYI:

  • today announced it has completed patient enrollment for its Phase 3 ORA-D-013-1 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D), surpassing its target of 675 patients with 710 patients enrolled.
  • I would like to thank all of the patients, investigators and partners involved in this clinical trial, all with the common goal of bringing forth a breakthrough in diabetes therapy.
  • “We are thrilled to announce that the world’s first Phase 3 oral insulin study, conducted under an FDA protocol, has achieved a significant milestone with the completion of enrollment.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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