Expanded Access Policy
At Aeromics, Inc. we are committed to improving the lives of patients by developing novel therapies that target aquaporin water channels. Achieving this goal requires us to establish the safety and efficacy of any potential new therapy and to secure marketing approval from the U.S. Food and Drug Administration (FDA). Our goal is to successfully advance our therapeutic candidates through the FDA approval process, in order to provide patients with broad access to our future products. We are currently at the beginning phases of the clinical trials that are necessary to assess the safety and effectiveness of our first investigational drug candidate in human subjects.
Some patients may desire access to new therapies that are not yet approved by the FDA. The best way to gain access to these unapproved therapies is through sponsored clinical trials. Clinical trials are designed to determine whether an investigational therapy is safe and effective for patients, and they are overseen by a team of medical professionals. There are circumstances where enrolling in a clinical trial is not possible. In these instances, an option known as Expanded Access may be available to the patient, although such availability must be determined on a case by case basis.
Expanded Access, also known as Compassionate Use, refers to the use of an investigational product that has not yet been approved by the FDA to treat, diagnose, or prevent a serious disease or condition. Providing an investigational product as part of an Expanded Access Program is a complex matter and is different from studying the investigational product as part of a clinical trials, where more comprehensive safety and efficacy data are collected. Aeromics understands the need for Expanded Access Programs under certain circumstances, and we recognize the importance of thoughtful consideration of all issues by sponsors of clinical trials and having an appropriate policy in place. Several complicated factors must be considered by sponsors as well as the medical institutions that may be involved in the Expanded Access Program, including the ability to provide the experimental treatment in a fair and equitable manner and whether there is an adequate manufacturing capacity to ensure sufficient supply for ongoing clinical trials.
Aeromics believes that participation in our clinical trial will be the most appropriate way to access our lead experimental therapy, AER-271, and therefore we are not making it available under an Expanded Access Program at this time. We are currently developing AER-271 with the aim of preventing brain swelling and improving outcomes in victims of ischemic stroke. AER-271 is currently in a first-in-human Phase 1 trial to investigate its safety, tolerability and pharmacokinetics in healthy human subjects. You can find more information about our ongoing clinical trial, including eligibility criteria, on ClinicalTrials.gov (Identifier: NCT03804476).
Aeromics will be re-evaluating this policy periodically and it may be revised at any time. We continue to advance our clinical development program for AER-271 in order to deliver this potential new therapeutic option to the largest number of patients in the shortest amount of time.
If you have questions about the Aeromics’ Expanded Access Policy, please contact us at: email@example.com