Sabon Muhimmin Mataki na 3 Nazarin Insulin Baka

Sakin Kyauta | eTurboNews | eTN
Written by Linda Hohnholz

Oramed Pharmaceuticals Inc. a yau ya sanar da cewa ya kammala rajistar haƙuri don nazarin Phase 3 ORA-D-013-1 na maganin insulin na baka ORMD-0801 don maganin ciwon sukari na 2 (T2D), wanda ya zarce burinsa na marasa lafiya 675 tare da 710 marasa lafiya sun yi rajista.             

ORA-D-013-1 shine mafi girma na binciken Oramed biyu na mataki na 3 da ake gudanarwa ƙarƙashin ingantattun ka'idojin Abinci da Magunguna na Amurka (FDA) don kula da marasa lafiya na T2D waɗanda basu da isasshen sarrafa glycemic na tsawon watanni 6 zuwa 12. Bayanan inganci don ORA-D-013-1 za su kasance bayan duk marasa lafiya sun kammala lokacin jiyya na watanni 6 na farko.

"Muna farin cikin sanar da cewa binciken insulin na baka na Phase 3 na farko a duniya, wanda aka gudanar a karkashin ka'idar FDA, ya sami gagarumin ci gaba tare da kammala rajista. Bayan watanni shida na jinya na ƙarshe na majiyyaci, muna sa ran sanar da sakamako a cikin Janairu 2023, "in ji Oramed Shugaba Nadav Kidron. "Muna matukar farin ciki game da yiwuwar zaɓin insulin na baki ga mutanen da ke fama da ciwon sukari. Ana isar da shi ta baki, insulin na baka yana kwaikwayon tsarin insulin na gaba kafin ya isa jini, yana samar da ingantacciyar sarrafa glucose na jini da yiwuwar rage haɗari da rikice-rikice masu alaƙa da insulin allura, gami da hauhawar nauyi da hypoglycemia, yayin da kuma yana da sauƙin gudanarwa. Ina so in gode wa dukkan majiyyata, masu bincike da abokan hadin gwiwa da ke da hannu a wannan gwaji na asibiti, duk tare da burin gama gari na samar da ci gaba a cikin maganin ciwon sukari. "

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

  • 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.

Game da marubucin

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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