Vilobelimab

24+ Companies Advancing Hidradenitis Suppurativa Treatment Pipeline with Novel Therapies

17 days ago

• DelveInsight's 2025 report reveals a robust pipeline with 24+ companies developing 24+ therapies for hidradenitis suppurativa, a chronic inflammatory skin condition affecting hair follicles. • Key players including InflaRx, Novartis, UCB, and Boehringer Ingelheim are advancing treatments targeting various inflammatory pathways with monoclonal antibodies and small molecules. • Novel mechanisms of action include targeting IL-36R (spesolimab), C5a (vilobelimab), IL-17A (secukinumab), and BTK inhibition (remibrutinib), offering hope for patients with limited treatment options.

InflaRx's Gohibic Receives EU Approval for COVID-19-Induced ARDS, Bolstering Market Potential

4 months ago

• InflaRx's Gohibic is the first and only treatment approved in the EU for SARS-CoV-2-induced ARDS, marking a significant milestone. • The European Commission's approval was based on positive Phase 3 PANAMO trial results, demonstrating a 23.9% reduction in mortality. • H.C. Wainwright reiterated a Buy rating for InflaRx, setting a price target of $8.00, citing Gohibic's market potential and pipeline. • InflaRx is exploring partnership and distribution options in Europe and is in discussions with the FDA for potential US approval.

InflaRx's Gohibic (vilobelimab) Receives European Commission Approval for SARS-CoV-2-Induced ARDS

4 months ago

• InflaRx's Gohibic (vilobelimab) has been granted marketing authorization in the EU for treating SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). • This approval makes Gohibic the first and only treatment approved in the European Union for this specific condition, addressing a critical unmet need. • The approval is based on Phase 3 PANAMO trial results, demonstrating a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. • Gohibic is intended for adult patients receiving systemic corticosteroids and invasive mechanical ventilation, with or without extracorporeal membrane oxygenation.

Site-Stratified Cox Regression Analysis Limitations Impact COVID-19 Mortality Study

5 months ago

• Site-stratified Cox regression in the PANAMO phase III study led to data attrition, excluding 16.6% of patients and compromising the p-value. • Exclusion of data from sites with no events or single patients underestimated the treatment effect of vilobelimab on COVID-19 mortality. • Cox regression without site stratification reported a positive finding (HR 0.67, p=0.026), which was considered more reliable by the FDA. • Country-level or region-level stratification may be more appropriate to account for geographic diversity and population heterogeneity.

European Medicines Agency Recommends Approval of Gohibic for SARS-CoV-2-Induced ARDS

6 months ago

• The European Medicines Agency (EMA) has recommended the approval of Gohibic for treating SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). • Gohibic offers a new therapeutic option for ICU patients suffering from ARDS caused by SARS-CoV-2, addressing a critical unmet need. • The recommendation is based on clinical data demonstrating the drug's potential to improve outcomes in this severe respiratory condition. • InflaRx, the company behind Gohibic, highlights the continued high mortality rates among ICU patients with SARS-CoV-2-induced ARDS.

InflaRx Receives EMA Recommendation for Vilobelimab in COVID-19 Treatment

6 months ago

• The European Medicines Agency (EMA) has recommended conditional marketing authorization for InflaRx's vilobelimab to treat COVID-19 in adult patients requiring invasive mechanical ventilation. • Vilobelimab is a first-in-class monoclonal antibody that selectively inhibits the complement factor C5a, a key mediator of inflammation in severe COVID-19. • The recommendation is based on data from a Phase III trial demonstrating improved survival rates in critically ill, mechanically ventilated COVID-19 patients treated with vilobelimab plus standard of care. • This regulatory milestone marks a significant advancement in the treatment landscape for severe COVID-19, offering a targeted approach to reduce inflammation and improve patient outcomes.

InflaRx's Vilobelimab Receives Positive CHMP Opinion for SARS-CoV-2-Induced ARDS

6 months ago

• The CHMP has recommended marketing authorization for InflaRx's vilobelimab (GOHIBIC®) for treating SARS-CoV-2-induced ARDS in mechanically ventilated adults. • The positive opinion is based on Phase 3 PANAMO trial results, which showed a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. • Vilobelimab, a first-in-class anti-C5a antibody, has already received Emergency Use Authorization from the FDA for treating COVID-19 in hospitalized adults. • InflaRx is planning to commercialize GOHIBIC® in Europe and will provide annual updates to the EMA on the BARDA-planned clinical platform study.

InflaRx's Gohibic Receives EMA Panel Nod for COVID-19 ARDS Treatment

6 months ago

• InflaRx's Gohibic (vilobelimab) received a positive opinion from the EMA's CHMP for treating adults with SARS-CoV-2-induced ARDS on mechanical ventilation and systemic corticosteroids. • The CHMP's recommendation is based on the Phase 3 PANAMO trial, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. • InflaRx is preparing to commercialize Gohibic in Europe and is assessing potential distribution partnerships within the EU, expecting minimal impact on its cash burn rate. • Vilobelimab, a monoclonal antibody targeting the C5a complement component, has received Emergency Use Authorization from the FDA for similar indications, pending full approval.

InflaRx's Vilobelimab Receives Positive CHMP Opinion for COVID-19-Induced ARDS

6 months ago

• The CHMP has recommended marketing authorization for InflaRx's vilobelimab (GOHIBIC) for SARS-CoV-2-induced ARDS in mechanically ventilated adults. • The positive opinion is based on Phase 3 PANAMO trial results, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. • Vilobelimab, a first-in-class anti-C5a antibody, has already received Emergency Use Authorization from the FDA for treating COVID-19 in hospitalized adults. • InflaRx is considering commercial distribution options with potential partners in the EU, with marketing authorization anticipated early next year.

InflaRx's Vilobelimab Receives Positive CHMP Opinion for COVID-19-Induced ARDS

6 months ago

• InflaRx received a positive CHMP opinion recommending marketing authorization for vilobelimab (GOHIBIC®) to treat SARS-CoV-2-induced ARDS in adults. • The recommendation is based on Phase 3 PANAMO trial results, which showed a 23.9% relative reduction in 28-day all-cause mortality compared to placebo. • Vilobelimab is intended for patients receiving systemic corticosteroids and invasive mechanical ventilation, addressing a critical need in severe COVID-19 cases. • InflaRx plans to commercialize GOHIBIC® in Europe and is exploring distribution partnerships, with minimal impact expected on the company's cash flow.

EMA's CHMP Recommends Multiple New Medicines and расширения Indications in November and December 2024 Meetings

6 months ago

• The CHMP recommended eight medicines for approval in November, including Augtyro for advanced solid tumors and Lazcluze for first-line treatment of advanced non-small cell lung cancer. • Seventeen new medicines were recommended for approval in December, bringing the total for 2024 to 114, including Andembry for hereditary angioedema and Beyonttra for transthyretin amyloidosis. • Extensions of therapeutic indication were recommended for 11 medicines in November and 8 in December, expanding the use of already authorized treatments like Keytruda and Ofev. • The CHMP also reviewed and updated recommendations for several medicines, including Leqembi for Alzheimer's disease and Mysimba for weight loss, and addressed the withdrawal of Alofisel for Crohn's disease.

InflaRx Advances Pipeline with Vilobelimab and INF904, Anticipates Key Milestones in 2025

6 months ago

• InflaRx's Phase 3 trial of vilobelimab for pyoderma gangrenosum (PG) reached its 30-patient recruitment milestone, with an interim analysis expected by the end of Q2 2025. • A Phase 2a trial for INF904, targeting chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), is set to begin by the end of 2024, with initial data expected in summer 2025. • The European Committee for Medicinal Products for Human Use (CHMP) is reviewing vilobelimab, with a decision anticipated around mid-November. • InflaRx's current funds of €62.0 million are projected to sustain operations into 2026, supporting the advancement of its complement inhibitor pipeline.

InflaRx's GOHIBIC (Vilobelimab) Selected for First BARDA-Sponsored Clinical Trial

a year ago

InflaRx N.V. announced that its drug GOHIBIC (vilobelimab) has been chosen by BARDA for a Phase 2 clinical trial to explore new treatments for acute respiratory distress syndrome (ARDS), a life-threatening lung condition with no currently approved therapy.

FDA Grants Emergency Use Authorization for Vilobelimab in Treating Critically Ill COVID-19 Patients

2 years ago

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, for the treatment of critically ill COVID-19 patients requiring invasive mechanical ventilation or extracorporeal membrane oxygenation. This authorization is based on the results of the Phase III PANAMO trial, which demonstrated a significant reduction in 28-day all-cause mortality.

Drug Development Updates