BioAegis Begins Phase 2 Trial of Gelsolin for ARDS Treatment

BioAegis Therapeutics, a leading biotechnology firm specializing in treatments for inflammatory conditions, has announced the enrollment of the first participant in its Phase 2 clinical trial investigating rhu-pGSN, or recombinant human plasma gelsolin, for Acute Respiratory Distress Syndrome (ARDS). This trial, listed under the identifier NCT05947955, aims to explore the potential benefits of rhu-pGSN in treating this life-threatening condition.

The trial is a randomized, double-blind, and placebo-controlled study designed to assess the efficacy and safety of rhu-pGSN when added to standard care. The primary efficacy endpoint is defined as survival without organ failure on Day 28. Participants, who have been diagnosed with moderate-to-severe ARDS (P/F ratio ≤150) due to infection, will receive six doses of rhu-pGSN intravenously. Besides evaluating efficacy, the study will also consider the safety and tolerability of the treatment, along with secondary outcomes.

The research activities will span 75 sites across the United States, Canada, the United Kingdom, and several European Union countries, including Belgium, France, Italy, Germany, the Netherlands, and Spain. The trial aims to enroll 600 participants.

This project is partially funded by the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50123C00067.

ARDS is a severe condition that can arise from various infectious diseases such as sepsis, trauma, or pneumonia. It leads to significant lung injury, causing fluid to leak into the lungs and making breathing difficult. To manage ARDS, patients often require oxygen therapy, mechanical ventilation, and intensive care, which poses a significant burden on healthcare systems. In the United States alone, more than 500,000 individuals are affected by ARDS each year, accounting for approximately 10% of all intensive care unit admissions. The mortality rate for ARDS stands at around 40%, and those who survive often face persistent complications, including impaired lung function and decreased quality of life.

Given the high mortality rate and the absence of effective treatments, there is an urgent need for innovative therapies for ARDS. Plasma gelsolin, a naturally occurring protein in the human bloodstream, plays a critical role in the body’s inflammatory response. In ARDS, endogenous levels of plasma gelsolin drop significantly, correlating with disease severity. The recombinant form of plasma gelsolin, rhu-pGSN, acts as an immune system regulator by disrupting the NLRP3 inflammasome and enhancing the clearance of pathogens by macrophages. Supplementation with rhu-pGSN aims to mitigate the inflammatory response linked to ARDS.

BioAegis Therapeutics is optimistic about the potential of rhu-pGSN to address the challenges posed by ARDS. Dr. Susan Levinson, CEO of BioAegis, expressed excitement about the commencement of the trial, emphasizing the company's commitment to saving lives and alleviating the strain on global healthcare resources.

BioAegis Therapeutics Inc., based in New Jersey, is a clinical-stage private company focused on leveraging plasma gelsolin to prevent adverse outcomes in inflammation-driven diseases. The company's platform centers on the recombinant form of plasma gelsolin, a highly conserved and abundant protein in healthy individuals. This protein helps keep inflammation localized to the site of injury and enhances the body’s ability to clear pathogens. By restoring normal levels of plasma gelsolin with rhu-pGSN, the treatment aims to support immune cell function and control inflammation, preventing it from spreading and causing further organ damage. Rhu-pGSN is a non-antibiotic, host-directed treatment for inflammation, applicable to both infectious and non-infectious causes.

BioAegis Therapeutics holds an exclusive license to a broad range of intellectual property from Harvard-Brigham and Women’s Hospital and possesses over 40 issued patents covering various medical fields, including inflammatory disease, infection, renal failure, and neurological conditions. The company also enjoys U.S. biologics exclusivity and has recently filed for new intellectual property in areas with unmet medical needs.