Advancing our Treatment for COVID-19
Plasma gelsolin, a naturally occurring protein in our body’s innate immune system promises to be a viable treatment for COVID-19.
“We are working hard to make plasma gelsolin therapy part of the solution for COVID-19 and other infections. While vaccines and antivirals hope to address the high transmission of COVID-19, it is the body’s overexuberant immune response which causes the severe lung damage and fatalities. Plasma gelsolin addresses the excess inflammation without suppressing the ability to fight infection.” – Susan L. Levinson, PhD, CEO
Gelsolin, "The Master Regulator of Inflammation", Disrupts the Course of Infectious & Inflammatory Diseases
The inflammatory response is essential to the healing process and to fight infection. The damage inflicted by COVID-19 is primarily mediated through an overly exuberant host response to the virus, not directly by the virus itself. This overblown reaction consists of excessive and prolonged inflammation leading to a harmful cytokine storm.
Gelsolin’s unique role is to modulate this necessary inflammatory response so that what was intended to be a mechanism of healing does not become an instrument of long term morbidity or death. In extreme circumstances like those present in COVID-19, gelsolin can become dangerously depleted, leaving the body exposed to the ravages of an unrestrained immune response.
Our approach is simply to supplement the protein which we have produced with a recombinant manufacturing process. This approach has been successful in over 20 animal models, including direct evidence of protection of the lungs. We recently completed a safety study in hospitalized pneumonia patients. We are now testing this in severely ill COVID-19 patients.
This human protein enhances the body’s ability to manage excess inflammation without suppressing immune function, unlike currently approved anti-inflammatory treatments.
The white paper, Plasma Gelsolin to Protect Tissue/Organs in Severe Coronavirus Infection without Compromising Pathogen Response, outlines how rhu-pGSN supplementation would work in COVID-19.
Update on our Progress (November 2020):
Expanded Phase 2 Clinical Trial Footprint within Spain and into Romania
Our COVID-19 study has recruited more than half 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. In addition to Hospital Universitari Saint Joan de Reus in Tarragona Spain, we are expanding our clinical trial footprint by adding a second Spanish site, Hospital Universitari de Tarragona Joan XXIII. We have already begun recruiting patients at the new site.
We 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 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 the EU.”
Details of the study can be found at:https://clinicaltrials.gov/ct2/show/NCT04358406
Manufacturing Capacity Secured
We have reserved a production slot for manufacturing of additional clinical supplies.
Pursuing Multi-Country Regulatory Approval
We are pursuing regulatory approval in 4 different countries in parallel. This means numerous interactions with each country-specific regulatory agency and thousands of pages of submissions. Assuming that we are able get the approval to enter into COVID-19 studies in the next few weeks, there are likely to be many more pneumonia patients than normal to recruit, making the actual trial time shorter.
We are continuously monitoring the regulatory environment and have been pursuing any fast-tracking made available, while expediting activities down the standard path.