Enrollment complete in Transition Therapeutics' phase 2a trial of regenerative product for diabetes

By Lisa Kerner

Erie, Pa., April 25 - Transition Therapeutics Inc. said it completed target enrollment of 30 patients for its exploratory phase 2a clinical trial of its regenerative therapy, E1-I.N.T., in type 2 diabetes patients.

E1-I.N.T. is a short-course combination therapy aimed at stimulating the regeneration of the body's insulin-producing cells (islet cells), according to a company news release.

The randomized, double-blind, controlled phase 2a clinical studies are to evaluate the safety, tolerability and efficacy of daily E1-I.N.T. treatments for 28 days with a six-month follow-up.

Data from this trial is expected in the third quarter of this year, the company said.

A total of 16 of 20 total patients with type 1 diabetes have been enrolled at six U.S. centers in Transition's clinical trail of E1-I.N.T.

Transition said preliminary interim data from the type 1 trial showed that three of the first four patients completing the four-week treatment period had a 35% to 75% reduction in daytime insulin usage with a favorable safety profile.

Located in Toronto, Ont., Transition is a product-focused biopharmaceutical company.

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