Patients and their families are at the core of everything we do.
Tern Therapeutics is committed to integrity, empathy, urgency, innovation, and determination as we work in partnership with patient communities at every stage of development to deliver treatments to those living around the world with rare diseases.
Our Commitment Clinical Research
We are committed to a rigorous clinical development process to evaluate the safety and efficacy of our investigational gene therapy candidates through clinical trials, while minimizing safety risks to patients. We believe that it is through clinical trials and regulatory approval that we can ultimately ensure safe and timely access to our medicines for as many patients as possible suffering from these devastating diseases.
For information about our clinical trials, please visit clinicaltrials.gov or contact our Patient Advocacy team at patientadvocacy@terntx.com.
We understand that there may be circumstances under which patients or caregivers may request treatment with our investigative therapies before they have been approved by regulatory agencies and outside of a clinical trial setting. This is sometimes called “expanded access,” “compassionate use,” “early access,” “right to try,” or a “named patient program.” We use the term “expanded access” to capture all of these.
When a treating physician requests expanded access outside of a clinical trial for a patient, Tern Therapeutics will review the request within 30 days and consider access to the investigational product for individual patient use under the requesting physician’s supervision. All requests will be reviewed in a fair and equitable manner and considered on a case-by-case basis to determine if certain criteria are met, including those designed to ensure patient safety, compliance with local laws and regulations, and no adverse impact to development of the investigational drug.
As provided by the 21st Century Cures Act, Tern Therapeutics reserves the right to revise this policy at any time.
Expanded Access Policy
Additional Resources
For more information about CLN2 disease and living with a rare disease, visit the following organizations:
Patients and their families are at the core of everything we do.
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