Enteris BioPharma said today it will use its Peptelligence™ platform to manufacture and characterize three oral tablet prototypes of KeyBioscience’s metabolic peptide, indicated for diabetes, obesity, and other metabolic disorders.

Under the clinical manufacturing services agreement, whose value was not disclosed, Enteris will also become the exclusive provider of finished product for use in preclinical and proof-of-concept clinical trial research.

“This agreement with Nordic Bioscience showcases the value of our Peptelligence platform to develop and enable the oral delivery of promising peptide and small-molecule therapeutics,” Joel Tune, Enteris’ CEO and executive chairman, said in a statement.

Key Bioscience agreed in 2013 to advance development of its metabolic peptides by licensing Enteris’ oral drug delivery and recombinant manufacturing technologies toward the formulation and clinical delivery of Peptelligence-enabled compounds, including type 2 diabetes, obesity, and other inflammatory conditions with high unmet medical and socioeconomic needs.

Peptelligence is designed to enable oral delivery of molecules that are typically injected, including peptides and Biopharmaceutical Classification System (BCS) Class II, III, and IV small molecules, in an enteric-coated tablet formulation.

Enteris’ formulation technology is made up of two key components—a permeation enhancer designed to loosen tight junctions in the intestinal enterocytes and allow paracellular transport; and citric acid, designed to act as a calcium chelator and membrane permeation enhancer, a pH-lowering agent that increases absorptive flux, and a membrane-wetting/charge dispersal agent.

KeyBioscience develops and hold all rights to dual amylin- and calcitonin-receptor agonist (DACRA) peptides for various metabolic and cartilage-related diseases.

KeyBioscience is a fully owned subsidiary of Nordic Bioscience, a global drug development organization specializing in clinical research and innovative biomarker research focused on connective tissue diseases.

“An oral delivery using Enteris's Peptelligence™ platform and manufacturing capabilities will be a value driver and a key to success. We look forward to progress with an oral formulation of our DACRA peptides into clinical trials and potential commercialization,” added Nordic Bioscience CEO Morten Karsdal.

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