Galectin Hopes To Set Surrogate Endpoints For NASH Cirrhosis, Despite Trial Failure

Failure of small NASH cirrhosis study does not present much read-through to the larger class of NASH drugs in development. Galectin hopes its ongoing Phase IIb trial will validate its galectin-3 inhibitor in a more advanced disease state than most NASH candidates are pursuing.

Liver

Despite the failure in a small Phase IIa trial, Galectin Therapeutics Inc. is hoping both that a larger ongoing trial testing its NASH candidate GR-MD-02 in NASH cirrhosis is better designed to succeed and that it can validate some non-invasive measures of liver stiffness to serve as a much-needed surrogate endpoint in nonalcoholic steatohepatitis.

The Norcross, Ga., company reported after market closing on Sept. 27 that GR-MD-02, a carbohydrate-based galectin-3 inhibitor, missed the primary...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approval Standards

More from Pathways & Standards

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.