Less than two months after getting the FDA go-ahead, Oramed Pharmaceuticals has enrolled the first patient in a Phase IIa trial for its oral insulin pill. The milestone apparently places it in the lead among companies trying to be the first to market with such a product.
Oramed will pursue a 30-patient study of ORMD-0801 over a few months and the process is expected to also include subsequent statistical analysis. Assuming all goes well, the Jerusalem company plans to move into a larger Phase 2b multi-center trial, which the company currently estimates it will launch in early 2014, a spokesperson told FierceDrugDelivery via email.
Oramed's take on an oral insulin pill would use an enteric coating, allowing the insulin protein to keep together well past initial ingestion. Unprotected insulin is digested in the gut and not absorbed in a useful way. ORMD-0801 is targeted to early-stage Type 2 diabetes, with the idea that a pill would boost a patient's adherence to treatment because it is easier (swallow and you're done). What's more, the company notes, orally ingested insulin is designed to mimic insulin's behavior in the body by passing through the liver before hitting the bloodstream.
Oral insulin would replace the use of frequent insulin injections, which patients often struggle to keep up with.
Oramed appears to be furthest along at this point. But it is not the only company racing to develop an orally ingested insulin pill. Novo Nordisk ($NVO) completed a Phase I single-dose trial earlier this year of its own oral insulin drug, developed in partnership with Ireland's Merrion Pharmaceuticals. And Biocon of India is allied with Bristol-Myers Squibb ($BMY) to develop a competing product.
The first insulin pill would change the game in diabetes treatment, hitting a surging market that already includes hundreds of millions of patients around the world and is growing by the day.
- read the release
Editor's note: This story was updated to reflect the fact that Oramed's new trial is a Phase IIa, with a larger Phase IIb clinical test expected in early 2014.