InflaRx receives positive CHMP opinion for GOHIBIC for SARS-CoV-2-induced ARDS

InflaRx (IFRX) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorization of GOHIBIC, under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation. The Company expects the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days. A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC’s approval in the EU, which is anticipated early next year, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority. Vilobelimab is included in this study as one of three new potential therapies for treating ARDS. InflaRx plans to commercialize the product in Europe under its proprietary brand name GOHIBIC. As previously indicated, InflaRx is considering commercial distribution options with potential partners in the EU. InflaRx does not expect this approach will have a meaningfully negative impact on its cash burn rate. The positive CHMP opinion is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.