GEn1E Lifesciences Inc. (“GEn1E”) is dedicated to the development of first-in-class medications for rare and inflammatory diseases. GEn1E is focused on developing its investigational new drugs, and is conducting clinical trials to assess safety and efficacy. The data from these trials we hope will support drug approvals from regulatory authorities, including the U.S. Food and Drug Administration (FDA), which would allow broader access to these therapies.
‍
Expanded access (sometimes referred to as “compassionate use”) is a potential pathway for a patient with a serious disease or immediately life-threatening condition to gain access to an investigational drug for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.   
‍
GEn1E believes that the best way to access our investigational new drugs is through participation in our clinical trials until there is sufficient data to demonstrate safety, tolerability, and efficacy that is confirmed by regulatory authorities.  Expanded access outside of a clinical trial may interfere with the conduct of ongoing clinical trials and delay access for other patients. We are therefore not accepting expanded access requests at this time. However, GEn1E reserves the right to change this policy at its discretion and may offer study material for compassionate use in the future once additional data is available. 
‍
You can find additional information about GEn1E’s current ongoing clinical trial by accessing https://clinicaltrials.gov, ClinicalTrials.gov Identifier: NCT05795465.
‍
For additional information about this policy, please contact clinical@gen1elifesci.com. Responses will be provided within approximately one business week.

Policy Adopted: April 2023

Contact us via our dedicated contact form