Overview

The Trethera Corporation is committed to advancing innovative therapies to address serious and life-threatening conditions. Our first-in-class drug, TRE-515, is in early stage clinical development and we are learning more each day about its potential to impact a broad range of conditions. We recognize that some patients may not qualify for clinical trials and may seek access to investigational medical products outside of these trials. In such cases, the FDA Expanded Access program, also known as “compassionate use”, may provide a pathway for patients to access investigational treatments when no comparable or satisfactory alternative therapy options are available. As the safety profile of TRE-515 continues to be characterized through our ongoing Phase I dose escalation clinical trial, we are also learning about drug-drug interaction (DDI) and the dose-exposure-response relationship. The upcoming recommended phase 2 dose (RP2D) trial, validating the results from the initial Phase I dose escalation clinical trial, will provide more clarity about the conditions for which TRE-515 offers the most clinical benefit.

Eligibility Criteria

To be considered for expanded access to our investigational products, the following criteria must be substantiated in full (incomplete or unsigned submissions will not be answered):

• Serious or Life-Threatening Condition: The patient must have a serious or immediately life-threatening disease or condition.
• No Comparable Alternatives: There must be no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Ineligibility for Clinical Trials: The patient is unable to participate in a clinical trial involving the investigational product for the serious or life-threatening condition.
• Potential Benefit Justifies Risk: The potential benefit to the patient justifies the potential risks of treatment.
• No Interference with Clinical Trials: Providing the investigational product will not interfere with ongoing TRE-515 clinical trials or the overall development program.

Request Process

Requests for expanded access must be submitted by a United States licensed physician who is responsible for the patient’s treatment. The physician should submit the signed and completed form to our expanded access team (info515@trethera.com) to outline the potential and eligibility for expanded access. If we agree to provide the investigational product, the physician will need to:

1. Obtain IRB Approval: Secure approval from an Institutional Review Board (IRB) for the treatment plan.
2. Obtain Informed Consent: Ensure the patient provides informed consent, acknowledging the investigational nature of the treatment and potential risks.
3. Submit FDA Request: Submit an expanded access request to the FDA, typically using Form FDA 3926 for individual patient access.

Fully substantiated and completed Right to Try access requests signed by a physician licensed to practice in the United States will be acknowledged within 10 business days of receipt and evaluated based on several general criteria, including but not limited to the following:

• The scientific rationale for clinical benefit
• Absence of any known contraindications
• Clear understanding of drug-drug interaction with current therapy
• Access to ongoing safety data

Contact Information

Physicians seeking expanded access to our investigational products should contact the Trethera Expanded Access Team at info515@trethera.com.

Trethera must review and approve all TRE-515 expanded access requests, to submit a request please use this Request Form.

Additional Information

For more information on the FDA’s Expanded Access program, please visit the FDA’s Expanded Access Information for Industry page.