Novo Nordisk recently announced that it is preparing to launch a global phase 3a clinical trial for semaglutide, an oral formulation for the treatment of type 2 diabetes, along with its drug development partner Emisphere.
Semaglutide is an analogue of the biological compound Glucagon-Like Peptide-1 (GLP-1). GLP-1 stimulates the pancreas to secrete higher levels of insulin and decreases the secretion level of glucagon. All and all, GLP-1 increases the body’s sensitivity to the presence of insulin, and now there is an artificial compound that is capable of mimicking this same function. Due to its biological similarities, after ingestion, semaglutide is expected to reduce the levels of glucose in the blood with a low risk of hypoglycemia. Moreover, semaglutide can induce weight loss since it encourages the reduction of food intake.
Semaglutide is provided in a tablet formulation, which includes in its composition a compound that enhances the biological absorption of the semaglutide molecule and works as a carrier that aids in the drug’s delivery into the system.
The phase 3a of the drug development program consists of a total of seven trials including approximately 8,000 type 2 diabetic patients. This new stage follows encouraging results from phase 2 proof of concept and regulatory authorities consultation.
The Semaglutide development project is the result of an agreement between Novo Nordisk and drug developer Emisphere, in which the first is working to develop oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere’s drug delivery carriers. Agonists are molecules that are able to bind to receptors, activating their biological response. In this case, Novo Nordisk is developing molecules that by binding to the GLP-1 biological receptors will activate their biological activity, increasing their biological response. This feature, together with being carried to the right receptors, makes Semaglutide a very promising compound in the treatment of type 2 diabetes.
Emisphere will later be able to receive additional contingent product development and sales milestone payments, and will also be entitled to receive royalties in the event Novo Nordisk commercializes products developed under their agreement.