Oramed hits midstage target in oral insulin trial

Hoping to get in on the potentially $15 billion oral insulin market, Israeli biotech Oramed ($ORMP) has released positive top-line results for its experimental treatment as it looks to race Novo Nordisk ($NVO) to be the first to market.

Its Phase IIb study, designed to check the safety and efficacy of its oral insulin capsule (ORMD-0801) in patients with Type 2 diabetes, met its primary objective of “achieving a significant reduction of weighted mean night-time glucose,” according to a statement from the company.

This U.S.-based, double-blind, 28-day randomized study of 180 adult Type 2 diabetes patients showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts.

The study also showed a good safety profile with no drug-related serious adverse events, the biotech said.

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

Oramed--which is also developing an oral GLP-1 analog capsule--said more detailed data would be presented “in the future,” but did not give any specifics.

Oral insulin is the dream of many in pharma and biotech, as it would eliminate the need for injections--something that many patients struggle with--and would therefore likely become a major blockbuster if it could produce similar safety and efficacy rates as injectable insulin.

Another attraction of an insulin pill is that it comes much closer to the path of natural insulin, which is produced in the pancreas and goes directly to the liver.

ORMD-0801 goes from the gut to the liver, while injected insulin circulates throughout the body before it gets there and uses a protective coating and a high-enough dose of insulin so that most of it can be destroyed and still deliver a clinically beneficial amount of the hormone.

But many companies’ pipelines are littered with failed attempts. Insulin and GLP-1s (which are used in some new classes of insulin) when taken orally are attacked by digestive enzymes in the gastrointestinal tract whose job it is to break down proteins--which is useful for food intake, but damaging if the protein is a drug that needs to stay intact.

And even if they were to somehow survive in the stomach, these large molecules would then have difficulty passing through the wall of the intestine and entering the bloodstream. Getting around this problem has proven difficult.

But both Oramed and the world’s largest diabetes drugmaker, Novo Nordisk, appear to be the closest companies to getting it right.

Last year, Novo released top-line data for a Phase II study that showed positive results for an oral version of its long-acting GLP-1 drug--the same mechanism used in its once-daily Type 2 insulin shot Victoza.

But just yesterday, Bristol-Myers Squibb ($BMY)--which has taken a major step back from diabetes after handing over its portfolio to AstraZeneca ($AZN) in 2013--confirmed that it had pulled out of a pact with India’s Biocon to develop their oral insulin candidate Tregopil.

In January, Biocon released top-line Phase I data for the drug, undertaken in the U.S., saying the dosing studies conducted with meals “show that there is a clear linear relationship between the dose of administered insulin Tregopil and the decrease in postprandial [reduction in blood sugar after a meal] glucose excursion rates.”

Sydbank analyst Soren Lontoft believes the Type 2 oral insulin market could be worth up to $15 billion as the global numbers of Type 2 patients nears the 400 million mark. Novo is expected to file for its drug in 2020.

- check out the release