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Immunic COVID-19 Trial, And Other News: The Good, Bad And Ugly Of Biopharma

Jun. 12, 2020 11:32 AM ETImmunic, Inc. (IMUX)OPK, SLNO


  • Immunic is cleared to start a phase 2 trial of its IMU-838 in COVID-19.
  • Soleno receives a setback.
  • Opko records positive data for somatrogon.
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Immunic Receives FDA Clearance for Phase 2 COVID-19 Trial

Immunic (NASDAQ:IMUX) announced that it has received the FDA allowance for starting its Phase II trial for IMU-838. The company expects the top-line data to be available later this year. The drug candidate is a selective oral DHODH inhibitor and has shown robust potential. IMU-838 mainly works by inhibiting the intracellular metabolism of activated immune cells.

CALVID-1 trial aims to assess the potential of the drug candidate as an oral treatment option for COVID-19. Initially, the trial is expected to enroll nearly 230 patients across different sites in the United States and Europe. The patients will be randomized and will receive 22.5 mg of IMU-838 twice daily, or placebo twice daily, for 14 consecutive days. The study will include hospitalized adult patients with a confirmed SARS-CoV-2 infection and meeting the criterion of clinical status category 3 or 4.

The prime endpoint of the study has been set as the proportion of patients free of invasive ventilation throughout the entire study period. The trial also has multiple secondary endpoints such as duration of hospitalization, duration of intensive care unit (ICU) treatment, 28-day all-cause mortality, time to clinical improvement, and viral titer reduction. Andreas Muehler, M.D., Chief Medical Officer of Immunic said:

IMU-838's profile, as an orally available DHODH inhibitor that employs a host-based mode of action, thereby providing broad-spectrum antiviral activity, makes it a unique, potential therapeutic option which may be applicable as either a standalone or combination therapy."

The company plans to initiate the trial shortly.

The CALVID-1 study will use an adaptive trial strategy and will include interim safety and efficacy assessments. If the clinical activity of the drug candidate is confirmed by the Independent Data Monitoring Committee after the first interim analysis, then a recommendation to expand the trial into a

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