FDA granted Emergency-Use Authorization (EUA) for GOHIBIC (vilobelimab) for the treatment of COVID-19 in hospitalized adults

The FDA granted Emergency-Use Authorization (EUA) for InflaRX NV's GOHIBIC (IV, anti-C5a monoclonal antibody, 800 mg, up to six doses, generic name vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). 

Key Updates

• InflaRx is a small, German-based biopharmaceutical company with a market cap of about $169M. GOHIBIC is their furthest developed asset and their only COVID-19 therapeutic, and currently not authorized nor approved for any other indication. The company submitted for EUA authorization in September 2022
• In the authorization letter, the FDA details GOHIBIC as a “recombinant chimeric monoclonal IgG4 antibody that specifically binds to the soluble human complement split product C5a after cleavage from C5 to block its interaction with the C5a receptor”, thought to be components that contribute to inflammation and worsening of COVID-19. The Fact Sheet lists VEKLURY, OLUMIANT (oral, JAK inhibitor, generic name baricitinib), and ACTEMRA (IV, IL-6 receptor agonist, 4-8 mg/kg, generic name tocilizumab), as available alternatives and acknowledges VEKLURY as being complementary to GOHIBIC due to their different mechanism of action 
• Based on the conclusion that potential benefits outweigh the risks, the FDA issued EUA authorization based on the Ph2/3 PANAMO study; a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of GOHIBIC in adult patients with COVID-19 pneumonia who required IMV or ECMO
  • The primary endpoint in the study was time to death through Day 28. The Kaplan-Meier estimated 28- Day mortality rate in the GOHIBIC + SoC group was 32% vs 42% for placebo + SoC (hazard ratio of 0.67 (95% CI [0.48, 0.96]). Day 60 mortality showed similar results with GOHIBIC + SoC group (37%) vs placebo + SoC (47%) 

CI Assessment

• Given GOHIBIC is an immunomodulator that is complementary to VEKLURY and that it is indicated for the most critically ill hospitalized patients within 48 hours of receiving IMV or ECMO, the anticipated impact of GOHIBIC’s EUA authorization is expected to negligible. 
• The Fact Sheet also details an inconvenient administration schedule, with GOHIBIC treatment initiating (Day 1) within 48 hours followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is still hospitalized (even if discharged from ICU). With the availability of other, more convenient immunomodulators like baricitinib and tocilizumab available for hospitalized patients with severe to critical disease, GOHIBIC is unlikely to see significant uptake.