BioAegis expands phase 2 studies using r-gelsolin to treat COVID lung injury in EU

November 20, 2020 0 By FM

The US based biotech company BioAegis Therapeutics, expands phase 2 trial of recombinant human plasma gelsolin (rhu-pGSN) for the treatment of lung injury in patients with 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 the continuation of recruitment based on a review of the safety data.

rhu-pGSN is currently being studied in severe COVID-19 patients where lung injury is a key hallmark of severe disease. 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.

The phase 2 trial in severe COVID-19 patents was initiated in August in Spain where COVID-19 cases were spiking. The study evaluates rhu-pGSN, and its ability to regulate the overactive inflammatory response often responsible for causing lung damage and death in COVID-19 patients. Unlike other immune-suppressive anti-inflammatory agents like dexamethasone, Rhu-pGSN does not compromise the immune response of the patient.

In the randomized, double-blind, placebo-controlled trial, rhu-pGSN is added to standard of care of patients with severe pneumonia due to COVID-19. The study will assess the efficacy of three doses of rhu-pGSN administered intravenously to hospitalised 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. The efficacy is tested based on the survival of the individual without organ failure on Day 14 without mechanical ventilation, vasopressors or dialysis. It will also measure the safety and tolerability of treatment along with secondary outcomes.

Supplementing depleted systemic levels of gelsolin has enormous potential to prevent debilitating and potential illness, organ failure in COVID-19 patients by disrupting the course of the cytokine storm, says the company.

Bio Aegis has published the results from its preliminary study named “Recombinant human plasma gelsolin improves survival and attenuates lung injury in a murine model of multidrug-resistant Pseudomonas aeruginosa Pneumonia” in the journal Open Forum Infectious Diseases. Based on the study, the National Institute of Allergy and Infectious Diseases (NIAID) demonstrated rhu-pGSN improved survival and reduced lung injury when added to meropenem, an intravenous antibiotic, in severe multidrug-resistant pneumonia.

Having shown efficacy against multidrug-resistant gram-positive and negative pneumonia, as well as severe flu, the team carried forward the study in severe COVID-19 patients.

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.”

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.