Vilobelimab

In the PANAMO phase III study, site-stratified Cox regression analysis excluded 61 patients, causing underestimation of the treatment effect and compromised p-value. Using Cox regression without site stratification, a positive finding was reported with a hazard ratio (HR) of 0.67 and a p-value of 0.026. Country-level or region-level stratification may be more appropriate to account for geographic diversity and population heterogeneity.

InflaRx announced the CHMP's positive opinion recommending marketing authorization of GOHIBIC (vilobelimab) for treating SARS-CoV-2-induced ARDS under exceptional circumstances. The company expects the European Commission to issue a marketing authorization within 67 days.

InflaRx N.V. received a positive opinion from the EMA's CHMP for its drug GOHIBIC (vilobelimab) for SARS-CoV-2-induced ARDS in adults on mechanical ventilation and systemic corticosteroids. The PANAMO Phase 3 trial showed vilobelimab improved survival rates, with a 23.9% reduction in 28-day all-cause mortality. InflaRx plans to commercialize GOHIBIC in Europe and is evaluating partnerships for EU distribution, expecting minimal impact on cash burn rate. GOHIBIC has FDA emergency use authorization for hospitalized COVID-19 patients within 48 hours of invasive mechanical ventilation or ECMO. Vilobelimab targets the C5a component of the complement system and is under continuous evaluation for safety and efficacy.

InflaRx announced the CHMP's positive opinion recommending marketing authorization of GOHIBIC (vilobelimab) for SARS-CoV-2-induced ARDS under exceptional circumstances. The company expects the European Commission to issue a marketing authorization within 67 days.

InflaRx announced financial results for Q3 2024, highlighting progress in its vilobelimab Phase 3 trial for pyoderma gangrenosum (PG), with an interim analysis expected by 2Q 2025. The company also plans to initiate a Phase 2a trial for INF904 by year-end 2024, with data anticipated in summer 2025. The European Committee for Medicinal Products for Human Use (CHMP) is reviewing vilobelimab for COVID-19-induced ARDS, with an opinion expected mid-November. InflaRx reported €62.0 million in cash, cash equivalents, and marketable securities, sufficient to fund operations into 2026.

PDS Biotechnology and InflaRx are small-cap medical companies. PDS has higher earnings but lower revenue than InflaRx, trading at a lower price-to-earnings ratio. Analysts favor InflaRx due to its stronger consensus rating and higher potential upside. InflaRx also has higher institutional ownership and lower volatility compared to PDS Biotechnology.

Drug repurposing, applying pre-approved drugs to new therapeutic uses, emerges as a cost-effective, efficient alternative to traditional drug discovery, especially in treating cancer, cardiovascular diseases, and infectious diseases like Covid-19. Recent advancements focus on systematic, patient-centered approaches, leveraging AI and network medicine for faster, more effective treatments. Immunotherapy, combined with repurposed drugs, shows promise in enhancing treatment outcomes, reducing development time and costs, and improving patient care across various diseases.

In 2020, 65 RCTs in Germany aimed to investigate COVID-19 treatments or preventive interventions, planning to include 20,696 participants from Germany. However, only 13.4% of the target sample size was recruited, with a median of 15 participants per trial. Most trials focused on drug treatments, with a significant portion funded by industry. Despite public investment, recruitment challenges and the impact of the pandemic on healthcare systems limited participation in COVID-19 research in Germany.