Novo Nordisk to Start Phase IIIa Trials for Oral Biologic

August 26, 2015
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

Novo Nordisk has big plans for its diabetes franchise. On Aug. 26, 2015 the company announced that it would begin Phase IIIa trials for oral semaglutide, a protein product that can be administered orally, rather than via injection. In the first trial of the program-which is slated to begin in 2016-doses of 3 mg, 7 mg, and 14 mg of the long-acting glucagon-like peptide-1 (GLP-1) analog will be compared with a 100-mg dose of sitagliptin, another oral diabetes medication. The other parts of the program will roll out during 2016 as well.

Phase IIIa of the SUSTAIN trial, a similar trial that concluded in July 2015, found that as a once-weekly injection, semaglutide helped people with type 2 diabetes achieve substantial improvement of blood glucose, lose weight, and was associated with a low risk of hypoglycemia. Compared with placebo (25%), 74% and 73% of the people treated with 0.5 mg and 1.0 mg semaglutide, respectively, achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) treatment target of HbA1c below 7%. The SUSTAIN program consists of five trials testing once-weekly semaglutide injection compared with other diabetes medications and a sixth trial investigating the cardiovascular benefits and other long-term outcomes with semaglutide over the course of two years.

To produce enough drug for the seven-part program for oral semaglutide, Novo Nordisk said it would invest approximately $2 billion in two new production facilities over the next two years in Clayton, North Carolina, and Måløv, Denmark. The creation of these facilities will create 800 new jobs, the company noted. The oral formulation is possible via a technology licensed from Emisphere Technologies that involves an absorption-enhancing excipient. According to Emisphere’s website, the excipient, called SNAC, “facilitates absorption of small and large molecules without altering their chemical form, biological integrity, or pharmacological properties,” providing a drug delivery alternative for molecules that would otherwise need to be injected. The Eligen delivery technology facilitates the transport of drugs across biological membranes primarily in the gastrointestinal tract.

“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 towards achieving that goal,” said Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, in a press release.

Source: Novo Nordisk