Immunic's lead MS drug hits primary and key secondary endpoints in PhII, but questions remain
Just a week after its lead program began enrolling patients in a study to treat Covid-19, Immunic Therapeutics is making more waves.
This time, the biotech is providing a glimpse at topline data from a Phase II trial studying the efficacy of vidofludimus calcium, or IMU-838, in relapsing-remitting multiple sclerosis patients. Taken orally, the candidate met its primary endpoint in reducing the cumulative number of combined unique active MRI lesions after 24 weeks for a 45 mg dose compared to a placebo, as well as a key secondary endpoint in such reductions for the 30 mg dose.
Immunic listed more than 50 other endpoints they studied in the trial, but due to “the study’s design, sample size and the patient’s follow-up duration” did not release any data other than the two topline endpoints.
Nonetheless, the news impressed Wall Street, as company stock $IMUX surged over 35% in pre-market trading to $23.17.
The trial for RRMS was double-blinded with a placebo arm and tested 210 patients. In the primary, 45 mg dose arm, CUA MRI lesion reduction reached 62% for the once-daily pill. The secondary arm, with 30 mg doses, saw lesion reduction hit 70%. Both numbers were statistically significant.
Though based in New York, Immunic’s trials were conducted internationally in 36 hospitals across four European countries. The biotech is also testing IMU-838 in a range of chronic inflammatory and autoimmune diseases, such as ulcerative colitis and Crohn’s disease.
IMU-838 works by blocking the enzyme dihydroorotate dehydrogenase, or DHODH, and inhibiting the intracellular metabolism of activated T and B cells. DHODH inhibitors can also produce a host-based antiviral effect regardless of specific virus proteins and structure. Immunic is hopeful this can lead to use as the treatment of several different viruses.
That effect also led to the UK’s NHS to sponsor a trial for the candidate in moderate to severe Covid-19 cases. An NHS trust at University Hospitals Coventry and Warwickshire began enrolling patients for an open-label, Phase IIb trial researching the efficacy of IMU-838 in combination with Tamiflu.
Image: Daniel Vitt, Immunic CEO