InflaRx NV (NASDAQ: IFRX) has received a significant boost with the European Commission's approval of Gohibic (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). This approval marks Gohibic as the first and only treatment authorized in the European Union for this severe complication of COVID-19. The decision follows positive results from the Phase 3 PANAMO trial, reinforcing InflaRx's market position and growth prospects.
The approval is specifically for patients receiving systemic corticosteroids and invasive mechanical ventilation, with or without extracorporeal membrane oxygenation (ECMO). This addresses a critical unmet need in managing severe COVID-19 cases that progress to ARDS, a condition characterized by widespread inflammation and lung injury.
Clinical Trial Data and Efficacy
The Phase 3 PANAMO trial, a pivotal study involving 368 severe COVID-19 patients, demonstrated a significant 23.9% relative reduction in 28-day all-cause mortality for patients treated with Gohibic compared to placebo. This statistically significant outcome underscores the clinical benefit of Gohibic in reducing mortality in this high-risk patient population.
Gohibic is a novel anti-C5a monoclonal antibody. It works by inhibiting the complement activation factor C5a, a key driver of inflammation in ARDS. By targeting C5a, Gohibic aims to reduce the excessive inflammatory response that leads to lung damage and respiratory failure in severe COVID-19 cases.
Analyst Perspective
H.C. Wainwright analyst Edward White reiterated a Buy rating on InflaRx following the EU approval, setting a price target of $8.00. White's valuation considers the probability-adjusted revenue forecasts for Gohibic and other pipeline products, including INF904. He employs a net present value approach, estimating long-term sales and applying a discount rate reflecting industry standards. Despite acknowledging commercialization and regulatory risks, the potential for substantial future revenue supports the positive rating.
Commercialization and Regulatory Outlook
InflaRx is currently evaluating partnership and distribution opportunities in Europe to maximize Gohibic's market reach. These strategies are not expected to significantly impact the company's cash burn rate. Furthermore, InflaRx is in discussions with the FDA regarding potential full approval of Gohibic in the United States. However, the FDA has indicated that an additional study would be required for a biologics license application.
While Gohibic's initial sales have been modest, with third-quarter sales in 2024 reaching €124,000, H.C. Wainwright forecasts sales to grow to €0.3 million in 2024 and €1.0 million in 2025. This projected growth reflects the increasing adoption of Gohibic as a key treatment option for SARS-CoV-2-induced ARDS in the EU.
