Emisphere Technologies has highlighted that Eligen licensee Novo Nordisk will initiate a global phase 3A development programme with oral semaglutide, a once daily oral formulation of the long-acting GLP-1 analogue semaglutide, for the treatment of type 2 diabetes.
Oral semaglutide is provided in a tablet formulation with an absorption-enhancing excipient, SNAC, which is one of Emisphere’s Eligen technology delivery agents or ‘carriers.’
Novo Nordisk has announced its decision to initiate the PIONEER global phase 3A programme consisting of seven trials and approximately 8,000 patients with type 2 diabetes.
Novo Nordisk’s decision to initiate this global phase 3A programme follows encouraging results from the proof of concept Phase II programme and consultations with regulatory authorities.
Emisphere CEO Alan L Rubino said: "Novo Nordisk’s decision to advance oral semaglutide into phase 3A development represents a significant milestone for our Eligen technology platform and supports our belief that products developed using our proprietary carriers, which facilitate absorption into the gastrointestinal tract, have the potential to overcome key bioavailability challenges commonly associated with oral administration of peptides."
"We believe the ability to replace injectable therapeutics with effective oral formulations can have a significant positive impact on treatment compliance and patient quality of life.
"As such, we will work to further expand our Eligen® platform to other therapeutic agents through additional partnerships with leading biopharmaceutical companies."
Under its GLP-1 license agreement, Novo Nordisk is working to develop and commercialize oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere carriers.
Emisphere will be eligible to receive additional contingent product development and sales milestone payments and will also be entitled to receive royalties in the event Novo Nordisk commercialises products developed under such an agreement.
Novo Nordisk is responsible for product development and commercialisation under the agreement.
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 an absorption-enhancing excipient, SNAC.
SNAC is an absorption-enhancing excipient included in the Eligen carrier concept. Semaglutide is a Novo Nordisk product candidate.