The FDA cleared Oramed's ($ORMP) oral insulin pill to begin Phase II trials, bolstering shareholder support for the small Jerusalem company.
Back in February, the FDA asked that Oramed perform a smaller study before entering its 146-patient Phase II trial of ORMD-0801. Having completed that study and gained this clearance, Oramed will now press forward with the goal of becoming the first distributor of an oral insulin option.
Oramed's shares rose 15% premarket Friday to $9.75 before settling back down to $9.24 by 3 p.m., an almost 9% jump overall. According to a Wall Street Journal report, the stock has more than doubled since the start of 2013.
The company designed the capsule with an enteric coating so the insulin protein would retain its integrity and effectiveness after crossing biological membranes in the gut. This would give the pancreas a respite, curbing the progression of diabetes during the early stages of the disease.
Diabetes affects 336 million people as of 2011, according to the International Diabetes Foundation, and that number is expected to hit 552 million by 2030.
- here's the release
- and here's the WSJ report (sub. req.)
Novo Nordisk passes single-dose oral insulin Phase I
Oramed presses forward into PhII with oral insulin pill
Oramed submits U.S. IND for oral insulin Phase II