Expanded Access Policy
Sagimet Biosciences Inc. (“Sagimet”) is dedicated to developing new therapies that have a positive impact on public health. Our ongoing clinical trials can be found by visiting the clinicaltrials.gov website. Consistent with Sagimet’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are currently focused on enrolling and conducting the clinical trials necessary to apply for, and potentially gain, regulatory approvals to make our medicines available to patients. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach is best suited to help us develop products that, if approved, could help patients.
We recognize that there may be situations where a patient with a serious or life-threatening condition may not be eligible for a Sagimet-sponsored clinical trial. However, at this time, Sagimet is not making any of its investigational drug candidates, including denifanstat, available via expanded access (also referred to as compassionate use). We have considered many factors in arriving at this determination, including making reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting, and our ability to maintain supply for clinical trials, from enrollment to completion. Nevertheless, we will evaluate and respond to expanded access requests on a case-by-case basis, consistent with the steps below.
1. How to request: With questions about Sagimet’s expanded access policy or to make an expanded access request, please contact access@Sagimet.com. All requests must be submitted by the patient’s treating physician and provide sufficient supporting detail to enable us to evaluate your request. The physician’s contact information must be included to enable us to respond.
2. Criteria for consideration of requests: Although Sagimet retains sole discretion in deciding whether to grant an expanded access request, the following criteria will guide our evaluation of requests:
- The patient has a serious disease or condition, or their life is immediately threatened by their disease or condition, and there are no available alternative treatments
- The patient is not eligible for an ongoing or planned clinical trial;
- The potential benefit to the patient clearly outweighs the potential risks of treatment with the investigational product
- The patient meets any other relevant medical criteria for expanded access to the investigational product, as determined by Sagimet
- The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition
- There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient population
- The provision of the investigational product will not interfere with or compromise the clinical development of the product
3. Timing: We will endeavor to acknowledge each submitted request from a treating physician within 15 business days of its receipt.
Sagimet is committed to evaluating all requests in a fair and equitable manner. Each request will be carefully considered by Sagimet whose decisions are final. Any early access we provide will be in line with the laws and requirements of the country involved. As authorized by the 21st Century Cures Act, Sagimet may revise this expanded access policy at any time. The posting of this policy by Sagimet does not serve as a guarantee of access to any specific investigational drug by any individual patient or physician.