Galectin (GALT) Announces Positive Guidance Following FDA Meeting on NASH Cirrhosis Program

Galectin Therapeutics (NASDAQ:GALT) announced positive FDA guidance from a discussion on the clinical trial program with its galectin-3 inhibitor GR-MD-02 in NASH cirrhosis. Based on the guidance, the company plans to advance GR-MD-02 towards a Phase 3 clinical study. Galectin shares reacted to the news, skyrocketing nearly 23% to $4.14.

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 (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.

“Planning for a Phase 3 development program represents a significant milestone for Galectin Therapeutics and a pathway forward for the development of GR-MD-02 as a potentially important therapy in patients with NASH cirrhosis,” said Dr. Peter G. Traber, M.D., CEO and CMO of Galectin Therapeutics. The basis for advancing to Phase 3 is the positive effects of GR-MD-02 on HVPG and the possible prevention or postponement of development of esophageal varices in the Phase 2 NASH-CX trial, which we believe is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in these patients. The potential choice between two primary endpoints for Phase 3 trials provides enhanced flexibility in designing the strongest trial to replicate the efficacy demonstrated in the Phase 2 NASH-CX trial. Additionally, the clinical trial design discussed with the FDA provides for interim analysis which may provide confirmation of Phase 2 results and enhanced confidence for the ultimate results of the Phase 3 trial.

“While the company believes the results of the Phase 2 NASH-CX trial may represent a breakthrough for patients with NASH cirrhosis and believes that the results meet the FDA requirements for Breakthrough Therapy designation, the FDA has not granted breakthrough designation at this time based on the Agency’s current assessment that additional confirmatory data are needed to identify the level of change in HVPG that is reasonably likely to predict clinical outcomes. Although we disagree with FDA’s decision not to grant Breakthrough Therapy designation at this time, we understand their position because our NASH-CX trial is to our knowledge indeed the first randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in HVPG in NASH cirrhosis patients. Importantly, the Phase 3 program will not be impeded by the lack of Breakthrough Designation at this time. The program continues to benefit from Fast Track designation which provides many of the same advantages as Breakthrough Therapy designation, including potential for accelerated approval and priority review.”

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