Tr1X is committed to developing products which can substantially improve patient lives by addressing serious or life-threatening diseases with significant unmet medical need. Tr1X’s investigational therapy, TRX319, for the treatment of primary or secondary progressive multiple sclerosis, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA), recognizing its potential to address such need.
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This Expanded Access Policy describes how Tr1X evaluates and responds to requests for access to its investigational medicinal products outside of a clinical trial. Such access is permitted under 21 CFR 312.305 and related FDA regulations, is subject to authorization and oversight from regulatory authorities and Institutional Review Boards and may only be considered when certain criteria are met.

Requests for expanded access must be submitted by a licensed treating physician on behalf of a patient and should include the following:

• a summary of the patient’s diagnosis and medical history;
• the rational for requesting access to the investigational medicinal product; and
• an explanation of why alternative therapies and/or clinical trials are not suitable.

These requests should be submitted to the contact information provided below eap@tr1x.bio and should include “Expanded Access Request” in the subject line of the email correspondence. Tr1X will acknowledge receipt of the request within five (5) business days of receiving the request.

Tr1X will evaluate each request for expanded access in MS or other indications in accordance with applicable laws, regulations and company policies. In conducting such evaluation, the following factors may be considered:

• whether the patient has a serious or life-threatening condition and lacks comparable or satisfactory alternative treatment options for their specific situation;
• the rationale for the use of the investigational medicinal product
  
• potential risk and benefit for the patient in context of the available data; and
  
• whether providing access would interfere with ongoing or planned clinical trials or drug development.
  

This Expanded Access Policy is subject to change without notice. Nothing in this Expanded Access Policy shall be construed as a guarantee of access to any investigational product to any individual patient. The investigational therapy described herein has not been approved by the FDA or any other regulatory authority for commercial use. Expanded access use of an investigational product may involve additional risks beyond those involved in participating in a clinical trial.