Ua fa'ailoa mai e Oramed Pharmaceuticals Inc. i le aso nei ua mae'a le lesitalaina o tagata ma'i mo lana Vaega 3 ORA-D-013-1 su'esu'ega o lana kapole inisalini tu'u gutu ORMD-0801 mo togafitiga o le ma'isuka ituaiga 2 (T2D), e sili atu i lona fa'amoemoe o le 675 ma'i ma le 710. gasegase ua lesitalaina.
O le ORA-D-013-1 o le tele lea o su'esu'ega e lua o le Vaega 3 a Oramed o lo'o fa'atautaia i lalo ole US Food and Drug Administration (FDA) fa'atulafonoina fa'amaonia e togafitia ai ma'i T2D e le'o lelei le pulea o le glycemic mo se vaitaimi o le 6 i le 12 masina. O faʻamatalaga aoga mo le ORA-D-013-1 o le a maua pe a maeʻa uma gasegase uma le 6 masina muamua togafitiga.
“Matou te fiafia lava e faasilasila atu o le vaega muamua o le vaega 3 o le suʻesuʻega o le inisalini tuugutu, na faia i lalo o le FDA protocol, ua ausia se mataʻina taua i le maeʻa ai o le lesitala. I le maeʻa ai o le ono masina o togafitiga o le gasegase mulimuli, matou te faʻamoemoe e faʻasalalau iʻuga pito i luga ia Ianuari 2023, ”o le tala lea a Oramed CEO Nadav Kidron. “Matou te matua fiafia lava i le fa'amoemoe o se filifiliga o le inisalini tu'u gutu mo tagata e maua i le ma'isuka. O le tu'u gutu, o le inisalini tu'u gutu e fa'ata'ita'iina le fa'atonuga o le inisalini a'o le'i o'o i le toto, e maua ai le pulea lelei o le kulukose o le toto ma ono fa'aitiitia ai lamatiaga ma fa'alavelave e feso'ota'i ma le inisalini tui, e aofia ai le fa'atupuina o le mamafa ma le hypoglycemia, ae faigofie fo'i ona fai. Ou te fia faafetai atu i gasegase uma, tagata suʻesuʻe ma paaga o loʻo aʻafia i lenei faʻataʻitaʻiga faʻataʻitaʻi, o loʻo i ai uma le sini tutusa o le aumaia o se tulaga manuia i togafitiga o le maʻisuka.
OA MEA E AVEA MAI LENEI TUSI:
- 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.
