BioAegis Therapeutics Awarded Second FDA Fast Track Designation for Recombinant Human Gelsolin to Treat Inflammasome-Driven Decompression Sickness (DCS)

Fast Track status accelerates regulatory pathway for BioAegis’ recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases.

Second Fast Track designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven conditions.

NORTH BRUNSWICK, N.J., Aug. 20, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN), for the treatment of decompression sickness (DCS). The company 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). This work is the culmination of an extended collaboration with Dr. Stephen Thom, Professor of Emergency Medicine at UMSOM.

BioAegis’ portfolio is built around plasma gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function.

Fast Track Accelerates Path to Patients for Inflammation-Driven Conditions
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 significantly accelerate time to market. For BioAegis, this designation highlights the therapeutic promise of rhu-pGSN and provides a clear regulatory pathway to expedite its development.

This marks the second Fast Track designation for BioAegis in recent months following one granted for Acute Respiratory Distress Syndrome (ARDS). These dual designations underscore the breadth and therapeutic potential of rhu-pGSN.

“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. This is just a first step in expansion of BioAegis’ portfolio to the range of challenging diseases driven by inflammasome activation,” states Susan Levinson, PhD., CEO of BioAegis Therapeutics.

Phase 2 DCS Study Expected to Deliver Rapid Proof of Concept
The study, 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), is being conducted in collaboration with the University of Maryland School of Medicine under a contract from the U.S. Office of Naval Research, and enrollment is expected to be completed in August 2025.

Earlier studies have demonstrated that DCS patients exhibit depleted gelsolin levels and elevated NLRP3-driven inflammatory microparticles. In preclinical models, rhu-pGSN supplementation was efficacious when administered after exposure to pressure changes, as well as when provided as a prophylactic agent.

DCS occurs when inert gases form bubbles in tissues and blood due to rapid pressure changes, triggering a dangerous inflammatory response and tissue damage. Previous research has shown that individuals with DCS exhibit depleted plasma gelsolin levels and elevated inflammatory microparticles, features that rhu-pGSN has been shown to directly counteract.

This study design will enable rapid generation of human proof-of-concept data and underscores the potential of rhu-pGSN to transform the treatment of decompression sickness for both military and civilian divers as a portable, field-deployable intervention, especially in remote or operational settings where hyperbaric chambers may not be available.

Gelsolin: A Multitasking Protein for Complex Inflammatory Conditions
Gelsolin holds immense promise as a therapeutic intervention for serious acute and chronic conditions due to its multifaceted mechanism of action.  In critical illness, gelsolin levels collapse, causing adverse outcomes. Supplementing gelsolin addresses this deficit directly, restoring immune balance while preserving host defense.  Gelsolin has been shown in both animals and humans to:

• Modulate the activation of the NLRP3 inflammasome.
• Enhance uptake and killing of microbial pathogens by innate immune cells.
• Bind to and remove harmful inflammatory mediators and toxic actin released from damaged cells.
• Regulate macrophage phenotype to modulate inflammation.

Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated many inflammatory diseases without suppressing immune function.

About BioAegis
BioAegis Therapeutics Inc. is a clinical-stage, private company whose mission is to capitalize on a key component of the body’s immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation.

BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, neurologic disease, and frailty. BioAegis will also have U.S. biologics exclusivity and has recently filed new IP in areas of unmet need.

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).This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067.

Investor Inquiries:
Steven Cordovano
203-952-6373
scordovano@bioaegistx.com

Media Inquiries:
Christine Lagana
clagana@bioaegistx.com

This press release contains express or implied forward-looking statements, which are based on current expectations of management.  These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies.  These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements.  BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.

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