AN2 Therapeutics Expanded Access Policy
AN2 Therapeutics, Inc. is a biotechnology company focused on the treatment of rare, chronic, and serious infectious diseases in areas of high unmet need. AN2 is currently developing epetraborole, an investigational drug intended for the treatment of treatment-refractory Mycobacterium avium complex (MAC), the most common type of nontuberculous mycobacteria (NTM) lung disease. A crucial step in the development of an investigational drug is to conduct clinical trials. Drugs being studied in clinical trials have unknown benefits and unknown risks that will not be understood until the clinical trials are complete.
Getting regulatory approval for a new medicine is the best way to bring rapid access to the greatest number of patients who may benefit.
Sometimes we are asked how patients may be able to access our investigational drugs outside of a clinical trial. In the United States, this is possible through “expanded access,” sometimes also referred to as “compassionate use.” Unlike the use of an investigational drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for treatment purposes, rather than to gather data on safety and effectiveness.
We believe the best way to access our investigational products is through participation in one of our clinical trials. We believe access to investigational therapies should be limited to controlled trials until such a time that sufficient information about the safety, tolerability, and effectiveness is generated from clinical trials. Until that time, expanded access outside of a clinical trial may interfere with the conduct of our ongoing trials and may also disrupt the progress of our development programs, which would, in turn, delay access to many other patients in need.
For all of these reasons, AN2 is not accepting expanded access requests at this time. We will reevaluate this policy in the future as information from our clinical trials becomes available. If the policy changes, this webpage will be updated.
If you have questions about this policy, or would like information about how to enroll in our clinical studies, please contact us at: info@an2therapeutics.com
