Immunic Therapeutics, a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies for the treatment of chronic inflammatory and autoimmune diseases, announced in February 2021 that its lead product candidate IMU-838, the company’s selective oral DHODH inhibitor, has shown evidence of clinical activity in hospitalized patients with moderate COVID-19.

The data showed clinical activity based on several secondary endpoints:

1. Clinically meaningful improvements in time to clinical recovery and time to clinical improvement
2. A substantial treatment effect in high-risk patients and patients aged 65 years and older
3. An antiviral effect of IMU-838 against SARS-CoV-2 in patients, as observed by viral titers
4. A robust anti-inflammatory effect, based on a more effective reduction in C-Reactive Protein (CRP) in treated patients, as compared to placebo
5. An indication, based on initial data from a post-hoc analysis of “Long COVID” symptoms, that IMU-838 may have the potential to prevent long-term fatigue

In addition, IMU-838 was found to be safe and well-tolerated in this patient population, which was already demonstrated by Immunic in other indications previously (e.g., multiple sclerosis). In particular, a significantly lower number of COVID-19-associated adverse events was observed.

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. A final analysis of the full randomized population of 223 patients, which will include data on all endpoints, including subgroup and sensitivity analyses, is expected to be available in the second quarter of 2021.