The US Biomedical Advanced Research and Development Authority (BARDA) has awarded a $20m contract to BioAegis Therapeutics for the development of plasma gelsolin for treating acute respiratory distress syndrome (ARDS).
BARDA’s division of research, innovation, and ventures (DRIVe), which is a part of the US Government’s Strategic Preparedness and Response division, provides funding for early-stage companies. In 2021, BioAegis signed a contract with BARDA to develop gelsolin for the treatment of sepsis and severe infections.
ARDS causes a fluid build-up in the lungs resulting from a severe complication of pneumonia, sepsis, Covid-19, or trauma. ARDS has an incidence rate of about 64.2 to 78.9 cases/100,000 person-years in the US, with 75% of these cases being classified as moderate to severe cases of the disease.
With ARDS emerging as a complication for Covid-19, multiple therapies have been in development to treat the disease, including a stem cell therapy by Novellus.
Gelsolin is a naturally occurring human plasma protein that can potentially reduce the severity of inflammation. As per BioAegis, gelsolin can modulate the activity of NLRP3 inflammasome and IL-1β-containing microparticles, which are responsible for causing an immune response.
Additionally, gelsolin can regulate the activity of microbial pathogens and inflammatory mediators. The protein, therefore, has the potential to decrease the inflammatory response that is associated with ARDS.
In January, the US Food and Drug Administration (FDA) cleared the investigational drug application (IND) for evaluating the recombinant plasma gelsolin for ARDS. The Phase II trial for studying the drug in ARDS is planned for 2023.
BioAegis is also investigating recombinant plasma gelsolin for treating type 2 diabetes. To that end, the US-based company has published two studies investigating gelsolin’s role in type 2 diabetes.
Previous BARDA contracts include multimillion-dollar Project NextGen awards for the development of anti-viral therapies. The agency recently signed a $704m contract to develop and procure Emergent BioSolutions’ Ebola virus disease therapy, Ebanga (ansuvimab-zykl).
