BioAegis Therapeutics Announces Site Activation and Patient Recruitment Underway in 13 Countries in Phase 2b Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Dis
600-patient study to assess efficacy of rhu-pGSN, an immune system regulator that interrupts the NLRP3 inflammasome and boosts macrophage clearance of pathogens.
Results from this landmark study expected to inform therapeutic strategies beyond ARDS, positioning rhu-pGSN as a promising intervention across a spectrum of acute and chronic inflammatory diseases.
NORTH BRUNSWICK, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for acute and chronic inflammatory diseases, announces that patient recruiting is underway across all 13 targeted countries for its Phase 2 study of rhu-pGSN for the treatment of ARDS. (NCT05947955). The Company's portfolio is built around gelsolin (GSN), a highly conserved and critical immune regulatory protein which controls dysfunctional inflammation without suppressing immune function.
Large Global Phase 2 Clinical Trial of rhu-pGSN Underway
The randomized, double-blind, placebo-controlled trial of rhu-pGSN added to standard of care will evaluate the efficacy (survival without organ failure on Day 28) of six doses of rhu-pGSN administered intravenously to hospitalized moderate-to-severe ARDS subjects (P/F ratio ≤150) caused by infection. It will also measure the safety and tolerability of treatment along with secondary outcomes.
Sites are recruiting patients in 13 countries including US, Canada, UK and the EU (Belgium, France, Italy, Germany, Netherlands, Spain, and others). Enrollment is targeted for 600 subjects.
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.
"We are excited with our significant progress in this important study. Focusing this study on the moderate to severe patient who will have severely depleted plasma gelsolin levels promises to address ARDS with a novel approach employing the protein whose role in the body is to balance the inflammation-healing axis,' stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis.
Effectively Treating ARDS Will Alleviate Massive Healthcare Burden
ARDS is a condition that can develop as a severe complication of sepsis, trauma, pneumonia or other infectious diseases, resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult, and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.
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