BioAegis Therapeutics Completes Recruitment for Phase 2 Clinical Trial of Its Inflammation Regulator, Gelsolin, for COVID-19 Treatment

MORRISTOWN, N.J., March 15, 2021 (GLOBE NEWSWIRE) --BioAegis Therapeutics, a clinical stage, private company developing therapies for infectious, inflammatory and degenerative diseases based on a portfolio built around gelsolin technology, announced today that it has completed enrollment for 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 which can cause organ failure and death without suppressing the immune system. Low levels of gelsolin are associated with severe illness and organ failure in COVID-19 patients. 

Phase 2 Clinical Trial of rhu-pGSN
BioAegis enrolled its last patient in the study which is being conducted at three sites – Hospital Universitari Sant Joan de Reus and Hospital Universitari de Tarragona Joan XXIII in Spain, and Spitalul Clinic de Boli Infecţioase şi Pneumoftiziologie Dr.Victor Babeș in Timişoara, Romania.

Dr. Antonio Castro, principal investigator and Dr. Sandra Parra, co-principal investigator at Sant Joan University Hospital in Reus, and their colleagues of the Catalan research group of the Internal Medicine service shared, "We were very enthused to conduct this study, as we had previously studied plasma gelsolin in patients with lupus with very interesting findings.  We look forward to the results of this study when follow up is completed."

The randomized, double-blind, placebo-controlled, proof-of-concept trial of rhu-pGSN added to standard of care will assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously to hospitalized COVID-19 subjects with 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,
“Our team is grateful for the efforts of the extended clinical study teams at each site who worked tirelessly to complete recruitment during this challenging pandemic. We look forward to demonstrating the value to patient care in this and other inflammatory conditions.”

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

Gelsolin is a Key Component of the Body’s Immune System
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.

About BioAegis
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.

Investor Inquiries:
Steven Cordovano
203-952-6373
scordovano@bioaegistx.com

Media Inquiries:
Christine Lagana
clagana@bioaegistx.com

This press release contains express or implied forward-looking statements, which are based on current expectations of management.  These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies.  These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements.  BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.