Oramed Pharmaceuticals Inc. (Nasdaq:ORMP) today reported success in its Phase IIa clinical trial of its ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes. The trial, conducted under a US Food and Drug Administration (FDA) IND (Investigational New Drug) protocol, met all primary and secondary endpoints.
The FDA had instructed Oramed to test the drug's safety, as well as its pharmacodynamic and pharmacokinetic effects, and that it had to show that the drug was safe before continuing onto a larger Phase IIb trial. It did so.
Oramed did not disclose the specifics of the study, saying that it will disclose the results at an upcoming scientific conference. 30 patients with adult onset diabetes participated in study to test the drug against a placebo. Statistically significant results of the drug's efficacy are not necessary expected in such a small study, only indications, but these were apparently present, given that the company said that it will carry out a Phase IIb study, which could cost over $10 million.
Oramed has published a shelf prospectus to raise $100 million on Nasdaq, but it already enough cash to carry out a Phase IIb study without the additional funding. "We are extremely pleased with the results which give a solid validation for Oramed's platform technology in general and our oral insulin program in particular," said Oramed CEO Nadav Kidron. "Following on the results from this type 2 diabetes study we are gearing up to start a multi-center Phase 2b study later this year. We are also excited about the potential of this drug for type 1 diabetes and plan to initiate a Phase 2a FDA study for this indication in the near term."
Published by Globes [online], Israel business news - www.globes-online.com - on January 30, 2014
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