Oramed Reports Positive Results in Final Cohort of Phase 2b Oral Insulin Trial

Oramed Pharmaceuticals 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.

The 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).

Patients 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.

Treatment 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.

"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. Following this conclusion of our Phase 2b trial, we are excited to further discuss with the FDA our planned Phase 3 trial," Oramed's Chief Executive Officer, Nadav Kidron, said.

"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," Joel M. Neutel, MD, the Principal Investigator of the ORMD-0801 Phase 2b trial, said. "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. 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."

The second cohort of the Phase 2b trial was a 90-day, double-blind, randomized, multi-center trial designed to evaluate the safety and efficacy and determine an optimal dose of ORMD-0801 as a treatment for patients with type 2 diabetes. The primary efficacy endpoint was a reduction in Hemoglobin A1C (A1C, also known as HbA1C, a key clinical measure of blood glucose control) at week 12.

In this second cohort, 78 U.S.-based patients were enrolled, treated, and randomized into five groups: 8 mg dosed once-daily; 8 mg dosed twice-daily; 16 mg dosed once-daily; 16 mg dosed twice-daily; and placebo dosed once-daily. The same two sites which were excluded from the statistical analysis in the primary cohort due to evidence of treatment‐by‐center interaction and a statistically significant placebo effect, were excluded in the second cohort, representing a patient population of 13 patients. Of the 65 patients included in the analysis, 57 completed through week 12. 

The once-daily and twice-daily arms of patients dosed at 8 mg achieved statistically significant (p-value 0.028 and 0.029, respectively) reductions from baseline in A1C of 0.95% (0.81% with placebo adjustment) and 0.95% (0.82% with placebo adjustment), respectively. Patients dosed once-daily at 16 mg and twice-daily at 16 mg did not show statistically significant reductions in A1C. ORMD-0801 demonstrated an excellent safety profile with no serious drug-related adverse events, hypoglycemia or weight gain.

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