Immunic(US:IMUX) Prnewswire·2024-10-22 10:30Core Insights - The Independent Data Monitoring Committee (IDMC) confirmed that the predetermined futility criteria for the phase 3 ENSURE program have not been met, allowing the trials to continue as planned [1][2] - The ENSURE program is expected to be completed in 2026, with the trials evaluating the efficacy of vidofludimus calcium for treating relapsing multiple sclerosis (RMS) [1][3] Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, with its lead asset being vidofludimus calcium (IMU-838) [5][6] - Vidofludimus calcium is designed as a next-generation treatment option for multiple sclerosis and has shown a favorable pharmacokinetic, safety, and tolerability profile in over 1,800 individuals [5][6] Clinical Trial Details - The ENSURE program consists of two identical multicenter, randomized, double-blind phase 3 trials (ENSURE-1 and ENSURE-2), each enrolling approximately 1,050 adult patients with active RMS across more than 100 sites in over 15 countries [3] - The primary endpoint for both trials is the time to first relapse, assessed over a period of up to 72 weeks, with key secondary endpoints including disability progression and changes in brain volume [3] Future Milestones - The next clinical milestone for vidofludimus calcium is the topline readout of the phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), expected to be released in April of the following year [2]