Immunic Reports Positive Phase 3 ENSURE Program Outcome

October 22, 2024

DENVER, Colo., Oct 22, 2024 (247marketnews.com)- Immunic (NASDAQ: IMUX) reported that, based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) recommended that its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS), trials are not futile and should continue as planned.

Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic, commented, “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.

“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.”

Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, added, “I am particularly excited about the positive outcome of the interim analysis of our phase 3 ENSURE trials, marking the successful achievement of a critical milestone for the 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. Our next clinical milestone for vidofludimus calcium is the top-line readout of our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), which we expect to release in April of 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.”

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