In its ongoing pursuit to become the first distributor of oral insulin, Oramed ($ORMP) is set to begin a Phase II trial of its Type 2 diabetes pill in the U.S. once a smaller study required by the FDA is complete.
The small Jerusalem-based company designed its insulin-delivering capsule, ORMD-0801, to curb the progression of diabetes during the early stages of the disease. The pill raises insulin levels to give the pancreas a respite, according to Oramed. By protecting the peptides and proteins with an enteric coating, the drugs can retain their integrity and effectiveness as they cross biological membranes in the gut.
In response to an IND Oramed submitted earlier this year, the FDA asked the company to perform a smaller study in a controlled in-patient setting for up to one week before it enters its 147-person Phase II trial, according to Oramed's release.
"We are very pleased to be in close and positive communications with the FDA, as well as having a clear path which meets the FDA's input," Oramed CEO Nadav Kidron said in a statement. "This positions us for imminent clearance from the FDA to proceed with our planned clinical studies."
According to the International Diabetes Foundation, the disease affected 336 million people as of 2011, a figure expected to hit 552 million by 2030. So Oramed isn't alone as it homes in on oral delivery--Bristol-Myers Squibb ($BMY) has an option on Biocon's candidate, Novo Nordisk ($NVO) is investing in oral insulin and Monosol ($MSRX) and Midatech patented a delivery platform in 2010.
- here's the release
- and some technical background from Oramed (pdf)