Immunic’s MS drug shows positive biomarker results in phase 2 trial, boosting investor confidence

Immunic, multiple sclerosis, biomarkers, clinical trial data, vidofludimus calcium

Immunic Therapeutics’ strategic decision to refocus its efforts earlier this year appears to be yielding positive results, drawing favorable reactions from investors in response to early biomarker data from its multiple sclerosis (MS) candidate. The biotech has been conducting a phase 2 trial of vidofludimus calcium, an inhibitor of dihydroorotate dehydrogenase, in patients with progressive MS. Preliminary data from 203 patients, representing about half of the eventual trial participants, showed that those receiving a 45-mg dose of the drug experienced a 6.7% decrease in serum neurofilament light chain (NfL) levels, in contrast to a 15.8% increase among the placebo group.

Among the 79 patients who could be evaluated at 48 weeks, those on vidofludimus calcium, also known as IMU-838, saw a 10.4% reduction compared to a 6.4% increase in the placebo group.

Furthermore, the data were analyzed within subgroups. Among the 59 patients with primary progressive MS (PPMS), those receiving the drug ended the 24 weeks with serum NfL levels that were 18.8% lower than those on placebo. Immunic highlighted that the only approved drug for PPMS, Roche’s Ocrevus, demonstrated a 12.4% reduction versus placebo at 24 weeks in the phase 3 ORATORIO trial.

“Particularly remarkable, the non-active progressive MS population, which represents the highest unmet medical need in MS, also showed differences in NfL levels over this relatively short observation period in favor of vidofludimus calcium.” 

– Jens Kuhle, M.D., Ph.D., head of the multiple sclerosis center at University Hospital Basel in Switzerland

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“The clear separation observed in serum NfL for vidofludimus calcium over placebo in the PMS patient population represents another major step forward for, what potentially could be, a first-in-class nuclear receptor related 1 activator for MS.” 

– Immunic CEO Daniel Vitt, Ph.D

Investors responded positively to the news, causing the biotech’s stock to briefly surge over 30% in premarket trading before settling around a 17% increase at $1.86 ahead of the market opening.

While the study’s primary endpoint regarding changes in brain volume and key secondary endpoints related to brain atrophy are still pending, the present data offer a promising yet tentative validation of Immunic’s strategic focus. Earlier this year, the company redirected its resources away from psoriasis and castration-resistant prostate cancer development, channeling its efforts toward multiple sclerosis and celiac disease.

This strategic shift was announced alongside phase 2b results for vidofludimus calcium in ulcerative colitis in April. In June, the biotech disclosed that the study had not met its primary endpoint, citing “unexpected interference” between the drug candidate and concurrent corticosteroid use. Consequently, Immunic decided not to advance the drug in that indication without a partner.

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