Oramed submits U.S. IND for oral insulin Phase II

Israeli company Oramed Pharmaceuticals has moved onto the next stage of development of its oral insulin, ORMD-0801, with an IND submission to begin a Phase II clinical trial in the U.S. in 147 people with Type 2 diabetes.

Oramed's oral formulations, delivered in enteric-coated capsules, protect peptides and proteins from digestion and help them to pass across the gut wall into the bloodstream. ORMD-0801 could also have potential in Type 1 diabetes, improving blood glucose control and cutting the number of daily insulin injections.

"This filing marks a major milestone for Oramed as it sets the ground for the largest trial on Oramed's oral insulin to date," said CEO Nadav Kidron.

Starting insulin treatment early in Type 2 diabetes could slow the disease's progression and cut the risk of long-term effects, but injections are unpleasant and inconvenient, and moving from tablets to injections is a big step for many people. An oral formulation of insulin could improve compliance in this group and provide an insulin profile that mimics the natural production more closely.

Oral insulin is a buzzing area. In a few examples, Bristol-Myers Squibb ($BMY) has picked up an option for Biocon's oral insulin candidate, IN-105; Novo Nordisk ($NVO) is investing in the area; and MonoSol ($MSRX) and Midatech are developing a PharmFilm-based buccal film.

- read the press release (pdf)

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