Danish pharmaceutical giant Novo Nordisk said Wednesday that it has begun Phase III clinical trials of an oral version to its diabetes treatment candidate semaglutide.
In July, the company announced positive results from Phase III testing of an injectable form of the drug, which is taken once a week to manage blood glucose levels for patients with type 2 diabetes.
The oral formulation for semaglutide, which would be taken once a day, completed Phase II trials in February with results showing doses of the drug were significantly more effective over placebo.
The company stated this phase of the testing process would consist of seven clinical safety and efficacy trials involving approximately 8,000 type 2 diabetes patients, with the inclusion of one trial to assess cardiovascular safety with use of the drug.
The first Phase III trial for oral semaglutide is scheduled to begin during the first quarter of 2016 with subsequent trials expected to start throughout the same year.
The announcement came with news that the company plans to invest $2 billion over the next five years to build new production facilities in Clayton, N.C., and in Denmark to meet future demand of its diabetes products.
“Delivering protein-based medicine like semaglutide in the form of a tablet and producing it on a large scale is a major challenge, and with the announcement today we have reached a significant milestone toward achieving that goal,” Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in a statement. “We are excited about the opportunities oral semaglutide represents as a new oral anti-diabetic agent to further improve type 2 diabetes treatment.”
Shares of Novo Nordisk were up .5% to $54.01 during morning trading on Wednesday.
