Math Behind Oramed’s Oral Insulin Suggests It’s Economically Viable

Novo Nordisk discontinued its oral insulin program in 2016.

We just found out why – because the dose of insulin required was 58x higher than the subcutaneous dose.

The cost issue will have less of an impact on Oramed because its oral insulin candidate uses human insulin rather than analog, about 10% of the price.

Oramed’s Phase II HbA1c trial is ongoing and will be completed around June.

Some interesting oral insulin news was just published that could prove bullish for Oramed Pharmaceuticals (ORMP). At first glance, the news may seem bearish, but go into the math and it actually is good news for the prospects of Oramed’s oral insulin candidate ORMD-0801, currently, undergoing Phase II trials.

It was two and a half years ago that diabetes giant Novo Nordisk (NVO) axed its development program for its oral insulin candidate I338. The abrupt cancellation occurred shortly after a Phase II trial succeeded for the insulin pill in a head-to-head comparison with Sanofi’s (NASDAQ:SNY) subcutaneous insulin glargine in insulin-naïve patients. Novo has been quiet as to exactly why the program was suddenly cancelled, but the reason finally became evident at the end of last month.

Back on January 21, the detailed results of this groundbreaking head-to-head trial were finally published in Lancet Diabetes and Endocrinology, and there is a simple answer as to why the entire program was grounded despite oral insulin showing some real promise. Reuters health crunched the numbers and what they found was that by the end of the trial, the actual amount of insulin administered in the oral I338 arm ended up being 58x the amount of insulin administered in the subcutaneous insulin glargine arm.

The reason that insulin doses had to be so much higher in pill form is that most of the insulin is digested before it gets past the small intestine into the liver. The absorption enhancing technology Novo was using that allows some of the insulin to successfully pass through is not good enough to save even most of it, so doses have to be dramatically higher to achieve a therapeutic effect comparable to insulin injections. Insulin analogs like what Novo was using in this trial are expensive and a 58x increase is not commercially viable. Instead of trying to tweak and improve the technology, however, Novo Nordisk simply scrapped the program.

https://seekingalpha.com/article/4242436-math-behind-orameds-oral-insulin-suggests-economically-viable