We are a clinical-stage biopharmaceutical company focused on developing a portfolio of internally-discovered, selective fatty acid synthase (FASN) inhibitors for the treatment of several diseases. We are developing TVB-2640 as an oral, once-daily, potential first-in-class selective FASN inhibitor for the treatment of nonalcoholic steatohepatitis (NASH). TVB-2640 is in Phase 2 of clinical development in NASH. The prevalence of NASH is increasing both in the United States and globally, and is correlated with increasing rates of obesity, type 2 diabetes, and metabolic syndrome. Metabolic syndrome is characterized by high blood sugar and lipid levels, insulin resistance and obesity.
Expanded Access Policy (for NASH)
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Expanded access may be appropriate when all the following apply:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.
Sagimet is currently not making its investigational therapies for NASH available on an expanded access or right to try basis. Sagimet intends to continue development studies in order to ultimately seek marketing approval from regulatory health authorities, and subsequent wider accessibility of the product to patients. Sagimet encourages participation in a clinical trial as the approach to obtain access to TVB-2640. Information about participation in Sagimet’s ongoing clinical trials can be found on the Clinicaltrials.gov website.
For more information about expanded access in the U.S., please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.
Consistent with the 21st Century Cures Act, Sagimet Biosciences, Inc. may revise this policy at any time.