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Breaking News, Trials & Filings

Hanmi Tests Biologic Against Diabetes, Obesity

GLP-1 inhibitor to go into Phase IIb

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Hanmi Pharmaceutical will launch a multinational Phase IIb trial of its biologic diabetes treatment, LAPS-Exendin4, with the goal of a weekly or monthly dosing regimen. The study will involve approximately 700 patients with type 2 diabetes or obesity and will be conducted at about 150 centers in a dozen different countries, including the U.S., Europe and Korea.

The trial is designed to assess safety and efficacy of LAPS-Exendin4, while determining its dose for Phase III trals. The trial is also designed to find out whether it is effective for controlling obesity.

LAPS-Exendin4 has demonstrated safety and efficacy through its Phase I trial conducted in Korea and separate Phase II studies conducted in the U.S. and Europe.

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