Novo Nordisk, a global healthcare company, to begin a phase 3a programme with oral semaglutide; a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide. The decision follows the encouraging results of the proof-of-concept phase 2 trial announced on 20 February 2015 and the subsequent consultations with regulatory authorities.
Novo Nordisk plans to initiate a global phase 3a programme, named PIONEER, comprising seven trials with approximately 8,000 people with type 2 diabetes. The PIONEER programme will include six safety and efficacy trials and one trial for evaluating the cardio-vascular safety of oral semaglutide. The first trial in the programme is planned for initiation in first quarter of 2016 and will investigate the efficacy and safety of once-daily oral semaglutide doses of 3 mg, 7 mg and 14 mg, compared to once-daily oral anti-diabetic sitagliptin dose of 100 mg. The remaining six trials of the PIONEER programme are all expected to be initiated during 2016.
In order to meet capacity requirements for current and future diabetes care products, including oral semaglutide, Novo Nordisk expects to invest an estimated 2 billion US dollars over the coming five years in two new production facilities; a new production facility for a range of active pharmaceutical ingredients in Clayton, North Carolina, US and a new drug-product facility in Måløv, Denmark. The final design and cost of the new production facilities will be presented for approval by the company's board of directors in 2016.
"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.
"We are excited about the opportunities oral semaglutide represents as a new oral anti-diabetic agent to further improve type 2 diabetes treatment."
Semaglutide (NN9924) is a new glucagon-like peptide-1 (GLP-1) analogue that can help people with type 2 diabetes achieve substantial lowering of blood glucose with a low risk of hypoglycaemia. In addition, semaglutide induces weight loss by decreasing appetite and food intake. The oral formulation of semaglutide is provided in a tablet formulation with SNAC, an absorption-enhancing excipient included in the Eligen carrier concept. The Eligen technology is licenced from Emisphere Technologies, Inc.