Oramed submits pre-IND for oral exenatide Type 2 diabetes pill

Following a string of successes in reaching midstage trials with its oral insulin pill, Jerusalem-based Oramed submitted a pre-IND application to the FDA for another of its oral capsules, this one containing exenatide, a hormone that stimulates the secretion of insulin by the pancreas.

Currently available only as an injectable treatment, exenatide is used in the treatment of Type 2 diabetes mellitus, reducing the risk of hypoglycemia and sometimes helping patients struggling with weight loss. Along those same lines, Oramed's ORMD-0901 is designed to offer the same benefits of intravenous exenatide in an oral form. Furthermore, Oramed CEO Nadav Kidron told FierceDrugDelivery, unlike the injected form, oral exenatide did not induce nausea in early, first-in-human trials. The company expects ORMD-0901 to help increase patient compliance by providing the same positive medicinal effects of exenatide without the unpleasant side effects.

"This is a very interesting drug that could be a game changer," Kidron said. "There has been a lot of interest in something like this for a long time."

The oral exenatide pill, a GLP-1 analog, is currently undergoing Phase Ib and Phase IIb trials in healthy patients and Type 2 diabetes patients, respectively. And Kidron expects to hear back from the FDA within a few months and to complete the current trials by the year's end.

Meanwhile, Oramed's oral insulin candidate, ORMD-0801 for Type 2 diabetes, is getting closer to becoming the first orally digestible insulin capsule on the market as it undergoes a Phase IIa trial also under an IND application with the FDA.

- here's the release (PDF)