About Epicrispr
Epicrispr Biotechnologies is a pioneering therapeutics company dedicated to developing curative treatments through state-of-the-art CRISPR and epigenetic technologies. Our research is grounded in rigorous science and our commitment to patient-centered innovation. We are advancing a pipeline of gene therapy products targeting serious diseases. Each program follows a development strategy designed to responsibly and efficiently generate the evidence required to bring potential therapies to patients as promptly as possible. A critical part of our development process is conducting rigorous clinical trials to evaluate the safety, tolerability, and effectiveness of our investigational therapies. Data collected from these studies forms the foundation of our regulatory submissions to agencies such as the U.S. Food and Drug Administration (FDA), with the ultimate goal of providing safe and effective treatments to patients on a broad scale.
What is Expanded Access?
Expanded Access, also known as compassionate use, is a potential pathway for patients with serious or life-threatening conditions to receive investigational therapies outside of clinical trials. The FDA may allow this type of access when no comparable or satisfactory treatment options are available and when the primary goal is treatment – not data collection.
Epicrispr’s Policy on Expanded Access
At this time, Epicrispr believes the most appropriate and scientifically sound way for patients to access our investigational therapies is through participation in our clinical trials. This ensures the collection of critical safety and efficacy data needed to advance our development programs and make these therapies broadly available as quickly and responsibly as possible.
Providing investigational products outside of clinical trials may compromise the integrity of our ongoing studies and delay access for the broader patient community. For these reasons, Epicrispr is not currently accepting expanded access requests. We will continue to evaluate this policy as our programs progress, and we will update this page should there be any changes.
At this time, we do not have an expanded access program that, outside of clinical trial participation, allows patients to have access to our investigational products prior to FDA approval.
Where to Find More Information
To learn more about our ongoing clinical trials, please visit ClinicalTrials.gov and search “Epicrispr.”
If you have any questions about our expanded access policy, please contact Epicrispr through the following email address: epic.clinicaltrial@epic-bio.com. We anticipate an acknowledgement of receipt of received requests within seven business days.
As authorized by the 21st Century Cures Act, Epicrispr may revise this expanded access policy at any time. Additionally, the posting of this policy by Epicrispr shall not serve as a guarantee of access to any specific investigational drug by any individual patient.