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Immunic Inc (NASDAQ: IMUX) completes the main analysis of Phase 1 CALVID-1 trial evaluating its lead asset, IMU-838. It is a selective oral DHODH inhibitor used in hospitalized patients with moderate COVID-19.
Though the data from 204 patients showed evidence of clinical activity, compared to placebo, the numbers were not very different in both arms. IMU-838 was found to be safe and well-tolerated.
18.5% of the IMU-838 treated patients reached clinical recovery at day 7, compared with 12.8% in the placebo arm. On day 28, 71.3% of the IMU-838 treated patients had recovered compared with 66.7% in the placebo arm.
Time to clinical improvement was found to be shorter in the IMU-838 treatment arm than placebo, and the incremental benefit increased over time.
42.7% of patients in the treatment arm reached clinical improvement, versus 38.5% in placebo. On day 28, the numbers were 90.9% and 87.4%, respectively.
The relative proportion of patients not improving was 6.8% greater in the placebo arm than the IMU-838 treatment arm at 14 days and 27.7% greater at 28 days.
Initial data from a post hoc analysis of "Long COVID" symptoms that remain even after elimination of the COVID-19 virus indicated that IMU-838 could potentially be an option for the prevention of long-term fatigue.
High-risk patients and patients aged over 65 years experienced a more substantial treatment benefit from IMU-838 than in the general patient population.
An anti-viral effect of IMU-838 on SARS-CoV-2 was observed by viral titers at the end of the treatment period (day 14) and the end of the study (day 28).
The final analysis of the complete randomized patient population of 223 is expected in the second quarter of 2021. This supplemental data set will contain full efficacy, virology, and drug trough level data, as well as the safety follow-up until day 60.
Price Action: IMUX slipped 16.6% at $21.1 in premarket trading on the last check Wednesday.
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