The potential treatment, semaglutide, which is a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, is being developed for once-weekly subcutaneous use and for once-daily oral administration for the treatment of type 2 diabetes. The oral formulation, OG217SC, is provided in a tablet formulation with an absorption-enhancing excipient, SNAC. SNAC is an absorption enhancing excipient included in the Eligen Carrier Concept, which is part of Eligen technology licenced from Emisphere Technologies by Novo.
Emisphere created Eligen Technology, its proprietary oral drug delivery platform, to facilitate the absorption of small and large molecules without altering their chemical form, biological integrity or pharmacological properties.
The company explaines that through the Eligen system, delivery agents or "carriers" facilitate or enable transport of therapeutic molecules, including large peptides and proteins, across biological membranes such as those of the gastrointestinal tract, allowing the drugs to exert their desired pharmacological effect. The delivery agents have no known pharmacological activity in the amounts used to enhance oral drug delivery and therefore may be considered excipients.
The Eligen Technology uses passive transcellular transport to enable drug molecules of all sizes to cross cell membranes, which the company claims is “not shared by other oral drug delivery systems currently available.” And once the drug and paired carrier leave the gastrointestinal lumen and reach the intracellular space, they disassociate. This leaves the drug free to pass directly to the circulation and exercise its intended pharmacological action.
The carrier is eliminated by normal excretion pathways. Studies have shown that this process does not involve chemical modification of the drug molecule and the integrity of gastrointestinal absorptive cells is maintained.
The trial results may give Emisphere a much-needed boost and new shed new light on its drug delivery tech. The company most recently in November 2014 reported a net loss of $14.4m for the quarter ended September 30, which compared to a net loss of $1.7m for the same quarter in 2013.
The company also said it’s continuing to pursue a number of pre-clinical programs in collaboration with other companies, as well as projects on its own, using the Eligen Technology to improve the oral absorption of selected molecules. The company is also looking to roll out its Oral Eligen B12 (1000 mcg) as a prescription product, though it previously tried to sell it as an OTC product, intended for use by B12 deficient individuals. No one from Emisphere responded to a request for comment.