InflaRx N.V. announced that GOHIBIC (vilobelimab) has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as one of three investigational therapies to be assessed in a Phase 2 clinical platform study exploring potential new options for the treatment of acute respiratory distress syndrome (ARDS). The Phase 2 multicenter, randomized, double-blind, placebo-controlled trial is expected to begin later this year. It is carried out by a global clinical research organization (CRO), PPD Development, LP (a clinical research business of Thermo Fisher Scientific Inc.), contracted by BARDA.

The trial is expected to be conducted at approximately 60 sites in the U.S., with a total target enrollment of 600 hospitalized adults with ARDS. Enrollment will include ARDS due to any etiology other than trauma, large volume aspiration, or transfusion. ARDS severity will be defined prospectively.

Vilobelimab, which will be supplied by InflaRx from its available stock, will be one of three host-directed investigational drugs assessed in this study, with the safety and efficacy of each investigational drug to be studied in its own patient cohort and compared against placebo. Each cohort is expected to enroll 200 patients (100 on investigational drug and 100 on placebo), with both arms in each cohort including standard of care as background therapy. The primary endpoint will be all-cause mortality at Day 28, with additional efficacy endpoints to include all-cause mortality at additional time periods, days of hospitalization, days in the ICU, daily oxygenation requirements, invasive mechanical ventilation endpoints, as well as other efficacy endpoints and biomarker measures.

This Phase 2 platform study will collect data in order to define subsets of patients with ARDS who may benefit from specific host-directed therapeutics. These data will inform the design of Phase 3 studies and identify a patient subpopulation most likely to benefit from each of the three drug candidates.