Galectin Therapeutics Receives FDA Feedback on Belapectin MASH Cirrhosis Program, Secures $10 Million Financing
核心洞察
Galectin Therapeutics received FDA written response showing alignment on patient population for belapectin registration trial in MASH cirrhosis (搜索) and portal hypertension (搜索).
The company will pursue a follow-up Type C meeting to finalize remaining clinical trial design components and present new biomarker data from the AASLD meeting.
Chairman Richard E. Uihlein provided an additional $10 million convertible line of credit, extending all debt maturity dates to June 2027.
Galectin Therapeutics Inc. (NASDAQ:GALT) announced December 19 that the U.S. Food and Drug Administration has provided written feedback on the development program for belapectin, its investigational galectin-3 (搜索) inhibitor for MASH cirrhosis (搜索) and portal hypertension (搜索). The FDA converted the company's initial request for an in-person or teleconference meeting to a written response format.
FDA Alignment on Patient Population
Based on the FDA's written feedback, Galectin Therapeutics believes there is alignment with the agency on the patient population proposed for enrollment in a registration trial. The company had previously reached an agreement with the FDA on the use of a centralized, blinded endoscopy review for esophageal variceal assessment and plans to apply a similar approach for variceal evaluation in its next study.
The company will pursue a follow-up Type C meeting to finalize remaining components of the next clinical trial design that were not fully resolved in the written response. This follow-up meeting will also provide an opportunity to present recently generated biomarker data, including findings highlighted at last month's American Association for the Study of Liver Diseases (AASLD) meeting, which could not be incorporated in the original submission due to the company's stated objective of obtaining FDA feedback before the end of 2025.
Path to Phase 3 Development
Galectin Therapeutics views this next FDA interaction as an important step toward ensuring full clarity as it advances belapectin towards subsequent clinical development in a pivotal Phase 3 clinical trial. The company is encouraged that the planned meeting will allow participation from prominent key opinion leaders, whose insights could not be integrated into the prior written-only exchange.
Dr. Khurram Jamil, Chief Medical Officer at Galectin Therapeutics, stated, "We appreciate the FDA's written feedback and are encouraged by the agency's evolving consideration of non-invasive tools and surrogate markers into clinical development for MASH cirrhosis (搜索). We look forward to discussing our updated data set within that regulatory context and further refining the clinical development strategy for belapectin."
$10 Million Financing Extension
Separately, the company has entered into a new $10 million unsecured, convertible line of credit financing agreement provided by its chairman, Richard E. Uihlein. In connection with this agreement, the maturity dates of all of the company's convertible lines of credit and convertible notes payable to its chairman have been extended through June 30, 2027. The company now believes that its cash resources, together with availability under these credit facilities, are sufficient to fund currently expected expenditures through at least March 2027.
Joel Lewis, Chief Executive Officer at Galectin Therapeutics, added, "Our focus remains on advancing belapectin for patients with MASH cirrhosis (搜索) and portal hypertension (搜索). We were pleased to receive feedback prior to year-end and look forward to continued dialogue as we work to finalize the next stage of clinical development. The strength of the data generated to date reinforces our confidence in belapectin's potential, and we look forward to advancing this program with continued momentum."
About Belapectin and MASH Development
Belapectin is a carbohydrate-based drug that inhibits the galectin-3 (搜索) protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (搜索) (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. According to the company, liver cirrhosis (搜索) is one of the most pressing medical needs and a significant drug development opportunity.