Galectin Therapeutics proceeding with plans Phase 3 clinical trial program.
Galectin Therapeutics announced it is proceeding with plans for a Phase 3 clinical trial program with its galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the FDA. The target population of the Phase 3 clinical trial will be patients with NASH cirrhosis without esophageal varices. The primary endpoint will be chosen from two endpoints that the FDA agreed may be acceptable: The change in hepatic venous pressure gradient, or HVPG, which is a measure of liver blood pressure, or the progression to esophageal varices. Both primary endpoints may be considered surrogate endpoints for clinical outcomes in the target population with NASH cirrhosis. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the company has a final clinical trial protocol that is acceptable to the FDA.
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|Date:||May 14, 2018|
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