Immunic's MS Drug Shows Mixed Results in Phase II Trial

Immunic, a biotechnology company focused on developing therapies for chronic inflammatory and autoimmune diseases, has reported mixed results from its Phase II clinical trial for vidofludimus calcium, an oral multiple sclerosis (MS) drug. While the trial failed to meet its primary endpoint, the company remains optimistic about the drug's potential based on disability-related outcomes.

Primary Endpoint Missed, But Disability Outcomes Encouraging

The CALLIPER Phase II study, which evaluated vidofludimus calcium in patients with progressive forms of MS, did not achieve statistical significance in its primary endpoint of slowing brain volume loss. The drug improved the annualized rate of brain volume change by 5% compared to placebo, falling short of the threshold for significance.

However, Immunic's CEO Daniel Vitt emphasized the importance of disability-related outcomes over brain volume changes. The trial showed a 20% lower likelihood of disability worsening events at 24 weeks in the vidofludimus calcium group compared to placebo. This effect was consistent or even increased in various patient subgroups, including those with primary progressive MS and those without inflammatory lesions at baseline.

Shift in MS Drug Development Focus

Vitt highlighted a significant shift in the field of MS drug development, stating, "Nobody should care at all about whole brain volume change anymore." He explained that the inclusion of brain volume as the primary endpoint was a "leftover" from the trial design settled five years ago. The focus has now moved towards using disability as a key endpoint, an approach Immunic is adopting for its upcoming Phase III trial.

Safety Profile and Future Prospects

The safety profile of vidofludimus calcium appeared favorable, with severe side effects occurring at similar frequencies between treatment arms (8.1% in the vidofludimus calcium group vs. 6.5% in the placebo group). Immunic reported no new safety signals of concern.

Looking ahead, Immunic is proceeding with the Phase III ENSURE program to further assess vidofludimus calcium, with data expected next year. Leerink analysts have expressed optimism about the drug's prospects, assigning a 50% probability of success for the Phase III trial.