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Emisphere Announces Positive Phase II OG217SC Data from Eligen Licensee Novo Nordisk

Emisphere Technologies has announced positive Phase II data from Eligen licensee Novo Nordisk concerning OG217SC.

OG217SC is the oral formulation of semaglutide, a long acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.

OG217SC is provided in a tablet formulation with an absorption-enhancing excipient SNAC, which is included in the Eligen Carrier Concept.

Novo Nordisk successfully completed the Phase II trial for OG217SC, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide, compared with an oral placebo or once-weekly subcutaneously administered semaglutide in 600 people with type 2 diabetes treated for 26 weeks.

Results of the study are available on Novo Nordisk’s website.

Based on results, Novo Nordisk announced it will initiate consultations with regulatory authorities, subsequent to which a decision about whether to progress OG217SC into Phase III development will be made.

Emisphere president Alan L Rubino said: "There are many challenges in developing an oral formulation of GLP-1, in particular obtaining adequate bioavailability."

"OG217SC addresses some of these key challenges by utilising Emisphere’s Eligen Technology to facilitate absorption from the gastrointestinal tract, overcoming major obstacles to effective oral delivery such as drug degradation and poor absorption."

Under its GLP-1 license agreement, Novo Nordisk is working to develop and commercialise oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere carriers.

In addition, under the GLP-1 license agreement, Emisphere could receive additional contingent product development and sales milestone payments, and would also be entitled to receive royalties if Novo Nordisk commercialises products developed under the agreement.

Under the agreement, Novo Nordisk is responsible for the development and commercialisation of products.

Emisphere's Eligen® Technology binds a delivery agent with a therapeutic compound without alternation. This process occurs when both agent and compound are in close proximity.
Originally published by Elsevier Journals on 24 May 2011, this white paper outlines an open-label, randomised, single-dose, parallel-group study of the pharmacokinetics of oral cyanocobalamin...
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