BioAegis Therapeutics has announced the enrollment of the first patient in its Phase 2 clinical trial investigating recombinant human plasma gelsolin (rhu-pGSN) for the treatment of Acute Respiratory Distress Syndrome (ARDS). This global, 600-patient study will evaluate the efficacy and safety of rhu-pGSN in individuals with moderate-to-severe ARDS.
Phase 2 Trial Details
The Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy of rhu-pGSN when added to the standard of care for ARDS. The primary endpoint is survival without organ failure on Day 28. Secondary outcomes include safety, tolerability, and other relevant clinical measures. The trial will administer six doses of rhu-pGSN intravenously to hospitalized subjects with moderate-to-severe ARDS (P/F ratio ≤150) caused by infection. The study is being conducted across 75 sites in the US, Canada, the UK, and the EU.
Rationale for Gelsolin Therapy
ARDS is a severe condition that can arise from complications of sepsis, trauma, pneumonia, or other infectious diseases, leading to life-threatening lung injury and fluid leakage into the lungs. In the U.S. alone, ARDS affects over 500,000 patients per year, representing approximately 10% of all ICU admissions. The mortality rate associated with ARDS is approximately 40%, underscoring the critical need for effective therapies.
Plasma gelsolin, a naturally occurring human protein, is depleted during inflammatory processes. Supplementation with recombinant gelsolin aims to modulate the overzealous inflammatory response characteristic of ARDS. Gelsolin has demonstrated several beneficial actions, including:
- Modulating the activation of the NLRP3 inflammasome and generation of IL-1β-containing microparticles.
- Facilitating the uptake and killing of microbial pathogens by macrophages.
- Binding to and removing harmful inflammatory mediators, including toxic free actin.
- Regulating macrophage phenotype to modulate inflammation.
Executive Perspective
"We are excited to have begun enrollment in this important study. Our commitment is to save lives by addressing the challenges of this complex disease, which is also a major drain on healthcare resources across the globe," stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis.
