COVID-19: MedStar Health Receives FDA Clearance to Trial an Oral Immunomodulatory Drug for COVID-19

Over the past year, our research team Dr. Thomas Fishbein, Dr. Khalid Khan and Dr. Alexander Kroemer from the MedStar Georgetown Transplant Institute has been working to develop a therapeutic to treat mild to moderate COVID-19 with the aim of reducing symptoms, eliminating disease progression, and preventing hospitalization.

The research team were initially motivated by the vulnerability of their immunocompromised transplant patients to COVID-19. The team demonstrated that SARS-CoV-2 infection results in acute inflammasome and caspase-1 activation – which in patients with existing chronic disorders leads to inflammatory cell death and subsequently both hyperinflammation and adaptive immune dysfunction. The team was able to identify a compound that could inhibit caspase-1 activation and thereby potentially attenuate the devastating immune effects of COVID-19.

With sponsorship from MedStar Health and in partnership with the MedStar Health Research Institute, the team has overseen the manufacturing of the drug, designed a clinical trial, and secured Investigational New Drug (IND) clearance from the FDA on September 24th.

The Phase 2, double-blind, placebo controlled, randomized, proof of concept trial will investigate the safety and treatment effect of the caspase-1 inhibitor belnacasan. Starting in mid-October, high-risk outpatients who present to MedStar Washington Hospital Center and MedStar Franklin Square Hospital with mild to moderate COVID-19 symptoms will be offered the opportunity to enroll in the trial under principal investigators Drs. Glenn Wortmann and Christopher Haas at their respective institutions.

This is the first time in MedStar Health history that the organization is serving as the sponsor in a commercial drug development program. If effective, the tablet being investigated would fill a key gap in the COVID-19 therapeutic arsenal as it can be taken orally and is more targeted than current, broad-based immunomodulatory treatments.