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news.Novel therapeutics developer Transition Therapeutics has received clearance from the FDA to initiate a clinical trial for its lead diabetes product, E1-INT, in type 2 diabetes patients.
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E1-INT is a short course combination therapy aimed at stimulating the regeneration of the body’s insulin-producing cells.
This type 2 diabetes clinical trial will be conducted in the US and will evaluate the efficacy, safety, and tolerability of a 28-day course of daily E1-INT treatments with a six-month follow-up.
“Expansion into type 2 diabetes significantly increases the market potential for this regenerative therapy, as in the US alone there are 11.7 million patients diagnosed with type 2 diabetes, representing 90% of all cases.” said Dr Tony Cruz, chairman and CEO of Transition.
The INT technology platform, covered by a broad patent portfolio, is based on the discovery that a short course of injections of naturally occurring peptides can regenerate insulin-producing cells in the body.
Two lead INT products are currently under development: E1-INT and GLP1-INT, a combination of one of the leading diabetes drug candidates, glucagon-like-peptide-1, with gastrin analogue (G1) currently in preclinical development.
In August 2004, Transition licensed these products to Novo Nordisk for upfront and milestone payments worth up to $48 million plus commercial milestones and royalties.