Oramed’s Oral Insulin Clinical Trial Meets Primary Endpoint

The oral insulin race is heating up, as Israel-based biotech, Oramed has released positive results from its Phase IIb clinical trial. Looking to cash-in on the potentially $15 billion oral insulin market, Oramed is trying to beat Novo Nordisk to launch the first oral insulin product on the market.

In a Phase IIb study assessing the safety and efficacy of Oramed’s ORMD-0801 oral insulin capsule, the experimental treatment met its primary objective of “achieving a significant reduction of weighted mean night-time glucose.” The study tested the effects of the drug on patients with type 2 diabetes.

The clinical trial – which was based in the US – was a 28-day double-blind, randomized study of 180 adult patients with type 2 diabetes. The patients taking the oral insulin showed a pooled night-time glucose mean percentage change of 6.47 percent from the run-in period before the trial. This percentage change represents a statistically significant decrease between the placebo and the treatment group.

According to Oramed, the drug showed a good safety profile, and no serious drug-related adverse event were reported. While the company – which is also developing an oral GLP-1 analog – reported that more data would be released in the future, they did not specify a date.

“This demonstration of safe and effective oral insulin delivery represents a transformative event in the treatment of type II diabetes,” said Nadav Kidron, CEO of Oramed. “We are delighted with the results and look forward to moving into Phase III trials.”

Oral insulin would eliminate the need for daily patient injections, making it a more convenient option for patients who struggle with subcutaneous drug delivery. If biotechs are able to show that oral insulin is just as safe and effective as the injectable drug, it could become a major blockbuster for the company that gets their product to market first.

Orally-administered insulin also has the potential to be more effective as it more closely follows the pathway of endogenous insulin. While injected insulin must circulate through the bloodstream before reaching the liver, oral insulin goes directly from the gut to the liver.

Novo Nordisk released positive Phase II clinical trial data for its oral GLP-1 drug last year. As neither company has reached the point where they’re ready to file for regulatory approval, it’s anybody’s guess which company might win the oral insulin race.