Immunic Inc (NASDAQ:IMUX) announced a positive outcome from the interim futility analysis of its Phase 3 ENSURE program which is investigating its lead asset vidofludimus calcium in relapsing multiple sclerosis (RMS).
The company said an Independent Data Monitoring Committee (IDMC) reviewed unblinded data and concluded that the trials had not met futility criteria, recommending that the study continue as planned without any changes.
"While Immunic remains blinded to all data, the IDMC's favorable recommendations in this interim analysis corroborate our initial assumptions for the design, powering and relapse rate of the twin Phase 3 trials of vidofludimus calcium in RMS, and suggest that they are in line with the data observed so far," Immunic chief medical officer Dr Andreas Muehler commented.
"In particular, the planned sample size seems appropriate to address the primary endpoint of time to first relapse. As the IDMC recommends, we are continuing the ENSURE trials unchanged, with completion expected in 2026."
The ENSURE program consists of two identical Phase 3 trials, ENSURE-1 and ENSURE-2, each aiming to enroll about 1,050 patients across more than 15 countries.
The trials focus on assessing the time to first relapse as the primary endpoint, with secondary measures including disability progression and brain volume changes.
Vidofludimus calcium is an oral drug candidate targeting multiple sclerosis and other autoimmune conditions. It acts by modulating immune response while preserving normal immune function, showing potential anti-inflammatory and neuroprotective effects.
Immunic CEO Dr Daniel Vitt welcomed the positive outcome as a “critical milestone” for the ENSURE program.
"We are confident in vidofludimus calcium's potential to transform the oral MS market and continue to believe that the Phase 3 program provides a clear and straightforward path towards seeking potential regulatory approval in RMS,” he said.
He highlighted that the next clinical milestone for vidofludimus calcium is the top-line readout from the company’s phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), expected in April next year.
“If this data set continues to show a neuroprotective effect for vidofludimus calcium, we believe our drug may be positioned as first-in-class oral treatment option for PMS, a form of MS with highest unmet medical needs,” Vitt concluded.