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Biopharmaceuticals Dermatology FDA

 News Release - October 21, 2020

FDA Grants Fast Track Status to Aegle Therapeutics' AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa

BOSTON and MIAMI, Oct. 1, 2020 -- (Healthcare Sales & Marketing Network) -- Aegle Therapeutics Corporation today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AGLE-102 for the treatment of patients with dystrophic epidermolysis bullosa ("DEB"), a rare genetic pediatric skin blistering disorder. AGLE-102 is an extracellular vesicle ("EV") therapy that delivers proteins, genetic material and regenerative healing factors to diseased and damaged tissue. AGLE-102 will be evaluated in DEB patients in a phase 1/2a trial initiating in 2021.

The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review and potential approval.

"We are pleased to have received Fast Track designation for AGLE-102. Aegle's EV therapy is unique in that it delivers collagen 7 protein, COL7A1 mRNA and regenerative healing factors to potentially address the complex nature of DEB," said Evangelos Badiavas, MD, PhD, Chief Scientific Officer at Aegle Therapeutics. "This designation will expedite the development and regulatory review of AGLE-102 and highlights the importance of providing novel treatments to this patient population."

About Aegle Therapeutics Corporation

Aegle Therapeutics (www.aegletherapeutics.com) is a privately held biotechnology company developing extracellular vesicles, including exosomes, secreted by mesenchymal stem cells as therapy for the treatment of dystrophic epidermolysis bullosa and other severe dermatological conditions. Aegle anticipates entering the clinic with AGLE-102 in early 2021.


Source: Aegle Therapeutics

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