BioAegis Therapeutics Announces US Navy Contract to Support Phase 2 Study of Recombinant Human Gelsolin, for Inflammasome-Driven Decompression Sickness (DCS)

Phase 2 proof-of-concept study for rhu-pGSN, a promising intervention across a spectrum of inflammatory diseases, to be studied as an intervention for the negative outcomes of decompression in SCUBA Divers

NORTH BRUNSWICK, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for acute and chronic inflammatory diseases, announces that it will conduct a Phase 2 study of rhu-pGSN for decompression sickness (DCS) 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. The Company’s portfolio is built around gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function.

Phase 2 Clinical Trial of Rhu-pGSN
The study, “Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers,” NCT06216366 is being conducted under a contract with the Office of Naval Research with the University of Maryland. It will investigate the use of rhu-pGSN as a pre- or post-exposure intervention in healthy trained SCUBA divers exposed to controlled hyperbaric conditions. The study is designed to assess the impact of rhu-pGSN on key inflammatory responses and microparticle production associated with decompression.

Decompression sickness occurs when inert gas bubbles form in the bloodstream and tissues due to rapid pressure changes, triggering an inflammatory cascade. Previous studies have shown that individuals with DCS exhibit depleted levels of plasma gelsolin and elevated levels of microparticles that contain inflammatory cytokines. In animal models, supplementation with rhu-pGSN both prevented and mitigated DCS-related complications.

This randomized, double-blind, placebo-controlled study will enroll healthy trained SCUBA divers at a single site and expose them to a standardized hyperbaric protocol (30 meters of seawater for 35 minutes). Participants will be randomized into three groups to receive either pre-exposure or post-exposure rhu-pGSN, or placebo. The study will assess a broad range of outcomes including plasma gelsolin levels, inflammatory markers like IL-1β, gas bubble formation, and well-being metrics.

Dr. Thom states, “If successful, this study could transform the way we manage decompression sickness by providing a portable, field-deployable treatment option. Reducing our reliance on hyperbaric chambers would greatly expand our ability to treat DCS in remote or operational environments, improving outcomes and readiness, a key goal for the Navy.”   BioAegis and University of Maryland are co-applicants on a patent filing listing Dr. Thom as an inventor.

Gelsolin: A Multitasking Protein for Complex Inflammatory Conditions
Rhu-pGSN 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 and rhu-pGSN has been shown in animal studies 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 NJ-based clinical-stage private company whose mission is to capitalize on a key regulatory 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’ lead product, 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). 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. NCT05947955

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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