August 20, 2025 — Leads & Copy — BioAegis Therapeutics, a biotechnology company focused on therapies for inflammatory diseases, announced that the FDA has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN), for the treatment of decompression sickness (DCS). BioAegis is currently conducting a Phase 2 study of rhu-pGSN for decompression sickness under a contract awarded by the U.S. Navy’s Office of Naval Research to the University of Maryland School of Medicine (UMSOM).
The FDA Fast Track program is intended to accelerate the development of new therapies for serious conditions with high unmet medical needs. Fast Track status enables more frequent interactions with the FDA, including rolling review of the marketing application, and eligibility for priority review, which can accelerate time to market. This marks the second Fast Track designation for BioAegis in recent months following one granted for Acute Respiratory Distress Syndrome (ARDS).
The Phase 2 study is titled “A Double Blind, Randomized, Placebo-Controlled Study Assessing The Efficacy And Safety/Tolerability Of Intravenous Recombinant Human Plasma Gelsolin (IV rhu-pGSN) As A Pre- Or Post-Exposure Prophylactic Intervention To Mitigate Proinflammatory Responses To Decompression After Exposure Of Healthy Volunteers With Training As Scuba Divers To High Pressure In A Hyperbaric Chamber” (NCT06216366). Enrollment is expected to be completed in August 2025.
Gelsolin holds promise as a therapeutic intervention for acute and chronic conditions due to its mechanism of action. Supplementing gelsolin addresses this deficit directly, restoring immune balance while preserving host defense.
BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. BioAegis’ rhu-pGSN, is currently being studied in a 600-patient global Phase 2 trial for patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) (NCT05947955).
Susan Levinson, PhD., CEO of BioAegis Therapeutics, states “Fast Track status is granted for products that are addressing areas of strong unmet need with novel, innovative approaches. Dr. Thom’s findings of the role of the NLRP3 inflammasome in this condition in divers is a powerful opportunity for BioAegis to demonstrate the benefits of our platform product which is clearly differentiated from other anti-inflammatory agents.”
Contacts:
Steven Cordovano
203-952-6373
scordovano@bioaegistx.com
Christine Lagana
clagana@bioaegistx.com
Source: BioAegis Therapeutics
