BioAegis Therapeutics (privately held) announced that it has completed its initial funding of over $3 million. The company will now seek to open a US IND and initiate a biomarker-driven Phase 2b/3 pivotal trial to demonstrate that repletion of human plasma gelsolin (pGSN) can prevent the spread of inflammation leading to Multiple Organ Dysfunction Syndrome (MODS) in the ICU. Separately, BioAegis Therapeutics is planning to advance this biologic in relevant Orphan Indications and initiate an effort to commercialize a plasma gelsolin biomarker diagnostic.

With eleven animal models of efficacy and two previous human trials, repletion of plasma gelsolin has demonstrated strong scientific rationale for human efficacy testing at this time. The evidence strongly suggests that Plasma Gelsolin Deficiency (PGD) may account for adverse outcomes in a variety of diseases in both chronic and acute conditions.

As the fourth most prevalent plasma protein and one of the main scavengers of toxic actin, pGSN is also known to bind with high affinity to multiple inflammatory mediators and to work as a systemic backstop to keep inflammation local. Furthermore, recent breakthrough findings in studies conducted at the Harvard School of Public Health have also shown that unlike previously known modulators of inflammation, pGSN is part of the body's innate immune system and works to boost the body's response to pathogens.

Dr. Thomas Stossel, BioAegis's founding scientist and discoverer of gelsolin, commented, "I am very pleased to be moving forward toward our goal of bringing plasma gelsolin into the clinic where it has enormous potential to save lives and drastically reduce health care expenditures."

Dr. Stossel is the Director of Translational Medicine at Brigham and Women's Hospital, and American Cancer Society Professor of Medicine at Harvard Medical School. BioAegis Therapeutics was founded by a group of highly experienced pharmaceutical, diagnostic and financial executives. Its mission is to harness the body's innate immune system to address serious outcomes in diseases driven by inflammation.