Patients Expanded Access
Policy
Consistent with Omega Therapeutics mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on conducting the clinical trials necessary to gain regulatory approvals to make our medicines available to patients. We are privileged to collaborate with clinical investigators who participate in our studies to develop new, safe, and effective therapies.
Expanded Access also called compassionate use, refers to the use of investigational therapy outside a clinical trial. Clinical trials are carefully regulated, monitored, and conducted in specific populations to assess safety and efficacy. Omega Therapeutics understands the need for expanded access programs, and we recognize the importance of having an appropriate policy.
The US Food and Drug Administration and other regulatory agencies’ policies should be considered when considering expanded access.
These include:
- The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or open clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
- The ability to provide a therapy in a fair and equitable manner, so that there is adequate manufacturing capacity to provide therapies across all ongoing clinical trials and expanded access programs
- Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients
Given the early state of our development programs, Omega Therapeutics believes participation in our clinical trials is the most appropriate way to access our investigational therapies. Therefore, currently we are not making our investigational products available through expanded access programs. If you have additional questions, please speak with your physician, or contact clinicaltrials@omegatx.com.
In line with the 21st Century Cures Act, Omega Therapeutics may revise this policy at any time.
Our investigational epigenomic controllers have the potential to transform medicine by delivering on the promise of epigenetics.
