Synlogic is committed to pioneering innovative medicines to treat a wide range of diseases and conditions. Synlogic believes that the best way for patients to access medicines not yet approved or licensed by the U.S. Food and Drug Association (FDA), “investigational medicines,” is to participate in clinical trials, where outcomes are used to establish the safety and efficacy of the medicine. Information about Synlogic’s current clinical trials can be found at www.synlogictx.com/for-patients/ and www.clinicaltrials.gov.
We recognize, however, that patients and their healthcare providers may request access to investigational medicines outside the context of clinical trials, such as when patients do not qualify for participation in a clinical trial and have exhausted other available treatment options. We understand these individuals’ desire for expanded access and the importance of providing access to investigational medicines when appropriate.
This policy sets forth Synlogic’s practices for providing expanded access to investigational medicines outside clinical trials to patients inside the United States. This policy applies to all Synlogic therapies that are under investigation but have not yet been approved or licensed by FDA.
Synlogic reviews all requests for expanded access on a case-by-case basis based on the following criteria:
- The disease or condition is serious or life-threatening.
- The patient is not qualified for enrollment in a clinical trial for the investigational medicine.
- There are no comparable or satisfactory treatment options available to treat the disease or condition.
- There is sufficient preliminary safety and efficacy data from clinical studies of patients to demonstrate that the potential benefit to the patient would likely outweigh the potential risks. Generally, a Phase I clinical trial must be complete for Synlogic to find sufficient preliminary safety and efficacy data to merit treatment.
- If there is a comparable or satisfactory treatment option available and the patient requests concurrent treatment with an investigational medicine, there must be sufficient preliminary safety and efficacy data from clinical studies to demonstrate that the potential benefit to the patient would likely outweigh the potential risks if concurrently treated with the investigational medicine.
- The provision of expanded access will not delay, interfere with, or compromise the completion of a clinical trial or the review or approval of the drug by a regulatory authority.
- Synlogic has the manufacturing capacity and supply necessary to provide access.
- The provision of expanded access does not otherwise pose challenges that would reasonably preclude the practical administration of the investigational drug.
An interdisciplinary team at Synlogic will review requests on a case-by-case basis to determine whether access should be granted in light of the above criteria. In addition to the above criteria, all legal and regulatory requirements must be fulfilled. For patients in the United States, FDA and an Institutional Review Board must approve the proposed expanded access use. The patient must provide informed consent and the treating physician must be legally and professionally qualified to administer the investigational treatment. Expanded access will not be provided where any of the above requirements are not fulfilled or where it is otherwise not permitted by federal, state, or local law.
Requests can be made by contacting Synlogic at firstname.lastname@example.org. Synlogic plans to acknowledge receipt of the request within three business days and communicate a decision to the requesting physician within seven business days.
As provided by the 21st Century Cures Act, this expanded access policy does not guarantee any patient the right to have access to Synlogic’s investigational medicines.