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. Now we are ready to test 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 (June 2020):
Preparing for Phase 2 COVID-19 Pneumonia Trial
We are working tirelessly towards expediting a Phase 2 pneumonia trial in the subset of COVID-19 patients. Our product, rhu-pGSN, is expected to save lives by quelling the overactive inflammation that is causing the lung damage, other organ damage and deaths in COVID-19 patients. We have greatly accelerated activities, in part by refocusing all of our employees and numerous consultants to this effort. We have modified our originally planned trial to focus on COVID-19 pneumonia patients and the COVID-19 hospital ICU environment.
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.