At Tolka AI Therapeutics, we are committed to advancing personalized phage therapy for Mycobacterium abscessus infections, initially focusing on Nontuberculous Mycobacterial (NTM) lung disease. In alignment with our mission to address unmet medical needs, we offer a limited Expanded Access Program for patients who are in dire need of alternative medicine and may benefit from our investigational therapies.
Criteria for Eligibility
To ensure safe and ethical implementation, we consider Expanded Access requests under the following conditions:
- The patient has a serious or life-threatening condition with no viable treatment options.
- The patient is ineligible for any current clinical trials.
- The treating physician submits a formal request on the patient’s behalf.
- Evidence suggests that the potential benefits outweigh the risks associated with the treatment.
- An adequate supply of the investigational phage product is available without compromising clinical trials or ongoing development.
- Local regulations and ethical guidelines permit such access.
How to Apply
Treating physicians or patients can submit inquiries or requests on behalf of their patients to expandedaccess@tolka.ai. Tolka.AI’s medical team will evaluate each request promptly and fairly, focusing on patient safety and compliance with local and international regulations.
Important Considerations
Participation in the Expanded Access Program may require adherence to confidentiality and other standard obligations. Once a product gains regulatory approval and is commercially available, access will transition to approved local distribution mechanisms. For more information about Expanded Access, please visit the FDA’s official page or contact us directly.
By offering this program, we hope to provide patients with a lifeline while advancing our mission to transform the treatment landscape for M. abscessus and other antibiotic-resistant infections.