Aegle Therapeutics Corp. issued the following announcement on October 6.
Aegle Therapeutics Corporation, a first-in-class biotechnology company committed to delivering cell-free therapy to patients affected by severe dermatological conditions, announced that the FDA has granted Rare Pediatric Disease (RPD) Designation to AGLE-102™ for the treatment of dystrophic epidermolysis bullosa (DEB), a skin blistering disorder. AGLE-102 is a composite of mesenchymal stem cell-derived extracellular vesicles that deliver proteins, genetic material and regenerative healing factors to diseased and damaged tissue.
"The FDA's grant of Rare Pediatric Disease designation following its earlier grant of Fast Track Designation to AGLE-102 for DEB underscores the significant unmet medical need of children and adults living with this debilitating disease. AGLE-102 has the potential to be the first multifaceted approach to treat this rare patient population," said Shelley Hartman, CEO of Aegle Therapeutics.
The FDA grants Rare Pediatric Disease designation for diseases that primarily affect children ages 18 years or younger and fewer than 200,000 persons in the U.S. If Aegle's new drug application ("NDA") for DEB is approved, Aegle may receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be sold to another company for their programs.
About Dystrophic Epidermolysis Bullosa
DEB is a debilitating, genetic, pediatric disease characterized by skin fragility that can result in widespread blistering, chronic wounds and significant scarring. There is currently no treatment or cure for DEB.
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.
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