Galectin Plans To Head Into NASH Pivotal Studies Without Biopsy-Evaluated Endpoint
Company is moving its galectin-3 inhibitor into Phase III in non-alcoholic steatohepatitis patients with cirrhosis – a very advanced disease setting – and also to validate endpoints that don’t require liver biopsy.
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Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.
Galectin faces a dual challenge - do its planned trial well and trust that the study design will lead the galectin-3 inhibitor belapectin to a niche position in NASH.
Public Company Edition: IPO performance has been mixed in 2019, but May has been the busiest month this year. Also, Insmed leads recent follow-on offerings and Dynavax restructures.