NEW YORK—Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has reported 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.
The placebo-controlled, double-blinded, 90-day Phase 2b trial of ORMD-0801 was in type 2 diabetes patients with inadequate glycemic control on oral antihyperglycemic agents. The primary efficacy endpoint was a reduction in Hemoglobin A1C at week 12 across three daily dose ranges — 8 mg, 16 mg and 32 mg.
Patients 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 (0.81% adjusted for placebo). Patients who had A1C readings above 9% at baseline experienced a 1.26% reduction in A1C by week 12.
“The statistically significant efficacy data, coupled with a clean safety profile characterized by no reported weight gain, no increase in serious drug-related adverse events and no hypoglycemia, further support ORMD 0801’s clinical potential. I believe the data demonstrated in this second cohort further validates the clinical potential of Oramed’s oral insulin to have a highly beneficial impact on the treatment of diabetes the world over,” explained Joel M. Neutel, M.D., the principal investigator of the trial. “The combined first and second cohort data for the lower doses illustrates that a lower dose would seem to be the right dosage level for future Phase 3 trials, and that in this case, less is more.”
Treatment with ORMD-0801 at all doses demonstrated an excellent safety profile. 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 discussions with the U.S. Food and Drug Administration regarding initiation of a Phase 3 trial.
“We believe the strong efficacy shown while treating patients at a lower dose further demonstrates ORMD-0801’s potential as a safe, non-invasive and effective oral insulin solution for the millions of people suffering from diabetes worldwide,” stated Nadav Kidron, Oramed’s chief executive officer. “Following this conclusion of our Phase 2b trial, we are excited to further discuss with the FDA our planned Phase 3 trial.”