Oramed Pharmaceuticals Inc. loni kede pe o ti pari iforukọsilẹ alaisan fun ikẹkọ Ipele 3 ORA-D-013-1 ti capsule insulin oral rẹ ORMD-0801 fun itọju iru àtọgbẹ 2 (T2D), ti o kọja ibi-afẹde rẹ ti awọn alaisan 675 pẹlu 710 awọn alaisan ti forukọsilẹ.
ORA-D-013-1 jẹ eyiti o tobi julọ ti awọn iwadii Ipele 3 meji ti Oramed ti n ṣe labẹ Awọn Ilana Ounje ati Oògùn AMẸRIKA (FDA) ti a fọwọsi lati tọju awọn alaisan T2D ti ko ni iṣakoso glycemic ti ko pe ni akoko 6 si awọn oṣu 12. Awọn data ṣiṣe fun ORA-D-013-1 yoo wa lẹhin ti gbogbo awọn alaisan ti pari akoko itọju oṣu mẹfa akọkọ.
“Inu wa dun lati kede pe iwadii insulin ẹnu akọkọ Alakoso 3 akọkọ ni agbaye, ti a ṣe labẹ ilana FDA, ti ṣaṣeyọri ibi-iṣẹlẹ pataki kan pẹlu ipari iforukọsilẹ. Ni atẹle oṣu mẹfa ti alaisan ti o kẹhin ti itọju, a nireti ikede ikede awọn abajade oke ni Oṣu Kini ọdun 2023,” Alakoso Oramed Nadav Kidron sọ. “A ni inudidun pupọ nipa ifojusọna ti aṣayan insulin ẹnu fun awọn eniyan ti n gbe pẹlu àtọgbẹ. Ti jiṣẹ ni ẹnu, hisulini ẹnu fara wé ilana hisulini endogenous ṣaaju ki o to de ẹjẹ, pese iṣakoso glukosi ẹjẹ ti o dara julọ ati idinku awọn eewu ati awọn ilolu ti o nii ṣe pẹlu hisulini abẹrẹ, pẹlu ere iwuwo ati hypoglycemia, lakoko ti o tun rọrun lati ṣakoso. Emi yoo fẹ lati dupẹ lọwọ gbogbo awọn alaisan, awọn oniwadi ati awọn alabaṣiṣẹpọ ti o ni ipa ninu idanwo ile-iwosan yii, gbogbo wọn pẹlu ibi-afẹde ti o wọpọ lati mu ilọsiwaju wa ninu itọju ailera atọgbẹ.”
OHUN TO MU KURO NINU AKOKO YI:
- 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.
