Press release
Oramed Reports Positive Results in the Final Cohort of Its Phase 2b Oral Insulin Trial
NEW YORK, Feb. 26, 2020 /PRNewswire/ -- Primary endpoints successfully met Results confirm significant clinical benefits of ORMD-0801 at lower dose treatment
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"NEW YORK, Feb. 26, 2020 /PRNewswire/ -- \n\n \n \n\n \nPrimary endpoints successfully met Results confirm significant clinical benefits of ORMD-0801 at lower dose treatment 0.95% (0.81% placebo adjusted) A1C reduction in patients treated once daily at 8mg Excellent safety profile Paves the way for FDA discussions on Phase 3 Study Conference Call to Review Results Today at 2:00 p.m. ETOramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced positive topline data from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, at lower dose regimens. ORMD-0801 has the potential to be the first commercially available oral insulin capsule for the treatment of diabetes.\nThe placebo-controlled, double-blinded, randomized, 90-day dose-ranging Phase 2b trial in type 2 diabetes patients with inadequate glycemic control on oral antihyperglycemic agents, assessed the change in A1C, the primary efficacy endpoint, from baseline to week 12, as well as safety endpoints, when ORMD-0801 was given in different regimens across three daily dose ranges (8 mg, 16 mg, 32 mg).\nPatients randomized in the trial treated with 8 mg of ORMD-0801 once daily achieved an observed mean reduction of 1.29% from baseline and a least square mean reduction of 0.95% from baseline, or 0.81% adjusted for placebo (p value = 0.028). Patients who had A1C readings above 9% at baseline and received 8 mg of oral insulin once daily experienced a 1.26% reduction in A1C by week 12.\nTreatment with ORMD-0801 at all doses demonstrated an excellent safety profile, with no serious drug-related adverse events and no increased frequency of hypoglycemic episodes or weight gain compared to placebo. The topline data from the second cohort represents the conclusion of the Phase 2b trial, and the company believes that the results now pave the way for FDA discussions regarding the initiation of a Phase 3 trial. \nA teleconference call will be held today, Wednesday, February 26, 2020 at 2 p.m. ET. The dial-in numbers for the conference call are 1-866-966-1396 for domestic callers and +44 (0)207-192-8000 for international callers. The conference ID is 6468688. To view the slides and hear the presentation con...