Aegle has recently completed the successful transfer of its manufacturing from the University of Miami to a commercial contract manufacturing organization. Clinical production is anticipated to begin early 2023.

Aegle has an open Investigational New Drug (IND) to treat dystrophic epidermolysis bullosa (“DEB”) patients using AGLE-102TM. Aegle expects to initiate a Phase 1/2a to treat burn patients mid-2023.

Aegle also has an open IND to treat severe second degree burn patients using AGLE-102TM and anticipates initiating a phase 1/2a trial in early-2023.

Pipeline

Expanded Access Program Policy

Aegle Therapeutics Corporation (Aegle) is developing a first in class therapy using extracellular vesicles, including exosomes, secreted by allogeneic bone marrow derived mesenchymal stem cells to treat severe dermatological conditions including dystrophic epidermolysis bullosa, a rare pediatric blistering disease, and burns. The company’s clinical development resources are focused on conducting clinical studies required by the U.S. Food and Drug Administration (“FDA”) and Aegle’s Platform regulatory authorities to establish the potential risks and benefits of our investigational products, and to obtain regulatory approval. As a result, we believe participation in clinical trials should be the primary route by which patients access investigational drugs.

Our goal is to improve the lives of people impacted by serious, underserved conditions. We share the urgency of patients seeking new treatments for potentially life-altering diseases and understand the interest in accessing our therapies outside of clinical trials and prior to regulatory approval. Aegle believes that investigational drugs should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessability to patients.

Expanded access, also referred to as compassionate use, is a channel through which the FDA allows physicians to request investigational medicines for patients. We do not currently offer any expanded access progams given that we are focusing our resources on development, clinical trials and regulatory approval. We encourage patients who are interested in accessing therapies in our pipeline to talk to their doctor about participating in a clinical trial. Information about all of our trials, including eligibility and locations, is available at ClinicalTrials.gov.

If we are able to offer expanded access in the future, we will update this policy. If you have further questions, please email us at info@AegleTherapeutics.com.