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Immunic, Inc. Announces That Oral Treatment IMU-838 Shows Evidence of Clinical Activity in Moderate COVID-19 in Phase 2 CALVID-1 Trial
- Clinical Activity of IMU-838 Confirmed Based on Multiple Secondary Endpoints, Including Clinically Meaningful Improvements in Time to Clinical Recovery and
About this update from Immunic, Inc.
[{"type":"text","content":"- Clinical Activity of IMU-838 Confirmed Based on Multiple Secondary Endpoints, Including Clinically Meaningful Improvements in Time to Clinical Recovery and Clinical Improvement -\n - Primary and Key Secondary Endpoints Were Not Evaluable Due to the Very Low Rates of Serious Complications in the Population of Hospitalized Patients With Moderate COVID-19 -\n - High-Risk Patients and Patients Aged Over 65 Years Experienced a More Substantial Treatment Effect of IMU-838 -\n - Robust Anti-Inflammatory Effect Observed, Based on a More Effective Reduction of C-Reactive Protein (CRP) in IMU-838 Treated Patients, as Compared to Placebo -\n - Initial Data From a Post Hoc Analysis of \"Long COVID\" Symptoms Indicates That IMU-838 May Have the Potential to Contribute to the Prevention of Long-Term Fatigue -\n - Conference Call and Webcast to be Held on February 18, 2021 at 8:00am ET -\n\n\nNEW YORK, Feb. 17, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that its lead asset, IMU-838, the company's selective oral DHODH inhibitor, has shown evidence of clinical activity in hospitalized patients with moderate coronavirus disease 2019 (COVID-19). This planned main analysis of the company's phase 2 CALVID-1 trial is based on data from 204 randomized patients and includes top-line clinical efficacy, safety, disease marker, and virology data. Although no formal statistical analysis was pre-specified for this main analysis, endpoints have been analyzed descriptively. A final analysis of the complete randomized patient population of 223, which will comprise data on all endpoints, including subgroup and sensitivity analyses, is expected to be available in the second quarter of 2021.\nThe primary endpoint of the randomized, placebo-controlled, double-blind trial was defined as the proportion of patients without any need for invasive ventilation through day 28. In contrast to the relatively high rates of ventilation reported in the first COVID-19 wave in early 2020, the CALVID-1 trial found an actual rate of less than 1% of invasive ventilation for hospitalized patients with moderate COVID-19. This very low event rate, consistent with the findings of many recent thi...