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.

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.

Even with aggressive medical management, 40% of ARDS patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the U.S. alone, ARDS affects over 500,000 patients per year, or roughly 10% of all ICU admissions With no effective therapies currently available for ARDS and its high mortality driven by excessive inflammation, there is an urgent need for innovative treatments in this field.

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. Depleted gelsolin is effectively restored in both animals and humans and has demonstrated the ability 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.

Gelsolin is a naturally occurring human protein found in the bloodstream, but is depleted by the inflammatory process. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated with ARDS and many inflammatory diseases