Immunic Therapeutics Chief Medical Officer Dr Andreas Muehler joined Steve Darling from Proactive to announce two major developments for the company’s lead drug candidate, vidofludimus calcium (IMU-838)—a nuclear receptor-related 1 (Nurr1) activator currently being investigated for the treatment of multiple sclerosis.
The company has successfully completed enrollment for both Phase 3 ENSURE trials (ENSURE-1 and ENSURE-2), each designed to assess efficacy, safety, and tolerability of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS). Together, the trials enrolled 2,221 adult RMS patients across more than 100 sites in 15 countries, including the United States, India, Latin America, MENA, and Central and Eastern Europe.
Each trial randomized patients in a double-blind fashion to receive either 30 mg of vidofludimus calcium or placebo once daily. The primary endpoint of both trials is time to first relapse over a 72-week period, with secondary endpoints including time to confirmed disability worsening (CDW) using the Expanded Disability Status Scale, Volume of new T2-lesions on MRI and time to sustained clinically relevant cognitive decline.
Dr. Muehler emphasized the significance of reaching this enrollment milestone, marking a major step forward in delivering a novel oral treatment option for RMS patients globally.
Immunic has also released new secondary endpoint data from its Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), further highlighting the neuroprotective potential of vidofludimus calcium.
Among the 467 PMS patients enrolled, vidofludimus calcium reduced the hazard ratio (HR) for 24-week confirmed disability worsening (24wCDW) by 24% compared to placebo (HR 0.76), based on EDSS measurements. Breakdown by PMS subtype showed a 33% reduction in Primary Progressive, a 19% reduction in non-active Secondary Progressive MS and a 34% reduction in active Secondary Progressive MS
These new insights reinforce vidofludimus calcium’s broad neuroprotective potential across progressive MS subgroups, where few effective treatment options currently exist.
With multiple data readouts anticipated and a global footprint already established, Immunic is taking significant strides toward changing the treatment landscape for both relapsing and progressive forms of MS.
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