BioAegis Therapeutics Initiates Phase 2 Clinical Trial of its Inflammation Regulator for COVID-19 Treatment

BioAegis Therapeutics Inc. recently announced it enrolled its first patient in its Phase 2 study of hospitalized patients with severe COVID-19 pneumonia. This study assesses BioAegis’ therapeutic, recombinant human plasma gelsolin (rhu-pGSN), and its unique ability to regulate the overexuberant inflammatory response that can cause organ failure and death. Low levels of gelsolin are associated with severe illness and organ failure in COVID-19 patients.

BioAegis recruited its first patient and began the study at Hospital Universitari Sant Joan de Reus in Tarragona, Spain. The randomized, double-blind, placebo-controlled, proof-of-concept trial of rhu-pGSN added to standard of care will enroll patients with severe pneumonia due to COVID-19.

The study will assess the efficacy (survival without organ failure on Day 14 without mechanical ventilation, vasopressors or dialysis) of three doses of rhu-pGSN administered intravenously to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5, or 6 on the World Health Organization (WHO) 9-point severity scale. It will also measure the safety and tolerability of treatment along with secondary outcomes.

According to Susan Levinson, PhD, CEO of BioAegis, “We are excited to move forward with this study to address the most severe outcomes of COVID-19. Two recent independent publications confirm that COVID 19 patients with lower gelsolin levels are more likely to exhibit organ damage and have higher WHO scores. Now, we have the opportunity to prevent these poor outcomes in patients in Spain.”

Details of the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04358406

Gelsolin is a human protein that is abundant in healthy individuals. It is a “master regulator of inflammation.” In the case of severe injury or infection, the body’s supply of gelsolin becomes depleted, which can lead to an overexuberant inflammatory response, organ damage and death, as seen in COVID-19. With the ability to replete gelsolin depleted by disease with rhu-pGSN, BioAegis is in a unique position to deliver therapeutics that have the potential to disrupt the course of the cytokine storm created by COVID-19.

Supplementing depleted systemic levels of gelsolin has enormous potential to prevent debilitating and potentially lethal ravages of inflammation, without compromising its essential function to fight infection and promote repair. Its unique qualities are:

-Host-based, not pathogen specific. Recent findings demonstrate gelsolin’s ability to treat both viral and bacterial infections, even those resistant to antibiotics.

-Naturally occurring human protein. Gelsolin is part of our innate immune system and our body’s first line of defense against pathogens.

-Controls excess inflammation without suppressing the immune response to threats. Unlike current anti-inflammatory treatments and steroids rhu-pGSN is non-immunosuppressive.

BioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of infection, inflammatory disease, renal failure, multiple sclerosis and other neurologic diseases. BioAegis has US biologics exclusivity and has recently filed new IP.