BioAegis Therapeutics Inc., a clinical-stage, private company developing therapies for infectious, inflammatory and degenerative diseases through a portfolio built around gelsolin technology, announced that it has expanded its clinical trial in severe COVID-19 to additional sites in Europe. The study has recruited more than one third of the expected enrollment and the independent Data Safety Monitoring Board (DSMB) has recently recommended continuation of recruitment based on a review of the safety data.

BioAegis’ Phase 2 clinical trial of recombinant human plasma gelsolin (rhu-pGSN) for the treatment of severe COVID-19 was initiated in August in Spain where COVID-19 cases were spiking. The study assesses rhu-pGSN, and its ability to regulate the overactive inflammatory response often responsible for causing lung damage and death in COVID-19 patients. Rhu-pGSN does not compromise the immune response as compared to other immune suppressive anti-inflammatory agents (e.g. dexamethasone). Low levels of this human plasma protein are associated with severe illness, organ failure and mortality in COVID-19 patients. 

Expanding the Clinical Footprint within Spain and into Romania

In addition to Hospital Universitari Saint Joan de Reus in Tarragona Spain, BioAegis is expanding its clinical trial footprint by adding a second Spanish site, Hospital Universitari de Tarragona Joan XXIII. BioAegis has already begun recruiting patients at the new site.

The company also received approval from the Romania National Agency for Medicines and Medical Devices (NMMD) to extend the trial into Romania. Recruitment for this third site has begun.

The randomized, double-blind, placebo-controlled, proof-of-concept trial of rhu-pGSN is added to standard of care of 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, "The independent Data Safety Monitoring Board has reviewed data from the initial patients and recommends that we continue the study as planned. With enrollment numbers growing, we look forward to further data including clinically meaningful endpoints in these severely ill COVID-19 patients once the study is completed.”

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.