CEO Nadav Kidron: We are proceeding with confidence toward IND approval in the US.
Drug delivery systems developer Oramed Pharmaceuticals Inc. last week reported positive results from its recently completed Phase IIb clinical trial of its oral insulin capsule, ORMD-0801.
The six-week trial, conducted in South Africa, was not for the US Food and Drug Administration (FDA). It included 29 patients with type 2 diabetes. The capsule was found to be safe and well tolerated, and there were no adverse side effects. Patients given the drug showed clinically relevant reductions in insulin c-peptide, fasting blood glucose and Hb1Ac levels were always higher compared with patients given the placebo. Average insulin levels were statistically significantly lower.
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