BioAegis Therapeutics ^Company

BioAegis on April 2 said it is submitting requests to the FDA and other regulators seeking to accelerate clinical trials of its lead product rhu-pGSN in severe infection, specifically severe community-acquired pneumonia (sCAP), including COVID-19, and has engaged “leading” infectious disease experts to advise the proof of concept clinical trial strategy. The company reasons that administering rhu-pGSN as an adjunct to standard-of-care measures could prevent or limit organ injury and death in patients with severe coronavirus infections. BioAegis said plasma gelsolin has been tested in over 20 animal studies, as well as a recent phase Ib/IIa study in hospitalized community-acquired pneumonia patients with no adverse safety signals.