(RTTNews) - Galectin Therapeutics Inc. (GALT) Friday announced that the U.S. FDA has provided written feedback on its development program for Belapectin, the company's investigational galectin-3 inhibitor for patients with MASH cirrhosis and portal hypertension.
Belapectin is a carbohydrate-based drug designed to inhibit galectin-3, a protein implicated in inflammation, fibrosis, and cancer. The therapy holds Fast Track designation from the FDA and is being advanced as a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, a severe form of liver fibrosis with limited therapeutic options.
The FDA converted Galectin's request for a Type C meeting into a written response. Based on the agency's feedback, the company believes there is alignment on the patient population proposed for enrollment in a registration trial.
Galectin had previously agreed with the FDA on the use of centralized, blinded endoscopy review for esophageal variceal assessment and plans to extend this approach in its next study. A follow-up Type C meeting is planned to finalize unresolved trial design elements and present new biomarker data highlighted at the recent AASLD meeting.
Dr. Khurram Jamil, Chief Medical Officer, noted that the company is encouraged by the FDA's evolving consideration of non-invasive tools and surrogate markers in MASH cirrhosis development.
CEO Joel Lewis added that the strength of data generated to date reinforces confidence in Belapectin's potential as Galectin prepares for a pivotal Phase 3 trial.
Separately, Galectin entered into a new $10 million unsecured, convertible line of credit agreement with Chairman Richard E. Uihlein. The maturity dates of all existing convertible lines of credit and notes payable to Uihlein have been extended through June 2027. With this financing, the company expects to have sufficient resources to fund expenditures through at least March 2027.
Galectin Therapeutics continues to explore strategies for advancing Belapectin while also pursuing combination immunotherapy programs in head and neck cancers and other malignancies, contingent on cash resources and partnerships.
GALT has traded between $0.76 and $7.13 over the past year. The stock closed Friday's trading at $4.38, down 28.90%.
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