Phase 3 of Multiple Sclerosis Therapy.
Immunic, Inc., a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced the first patient enrolled in its phase 3 ENSURE program of lead asset, vidofludimus calcium (IMU-838), the company’s selective oral DHODH inhibitor, in patients with relapsing multiple sclerosis (RMS).
“Enrollment of the first patient in ENSURE, which comes on the heels of initiating our supportive phase 2 CALLIPER trial in patients with progressive multiple sclerosis, marks an important inflection point for Immunic as we advance our lead asset, vidofludimus calcium, into active clinical phase 3 development,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Based on the strong activity observed in our phase 2 EMPhASIS trial and the drug’s well-established safety and tolerability profile to date, we believe that the design of the ENSURE program provides a straightforward path towards potential regulatory approval of vidofludimus calcium in RMS.”
“The progression of this pivotal phase 3 program for vidofludimus calcium and approval of the trial design by many ethics committees and regulators reflects and validates our approach,” added Andreas Muehler, M.D., Chief Medical Officer of Immunic. “The ENSURE program, along with the supportive phase 2 CALLIPER trial in progressive multiple sclerosis, designed to corroborate the neuroprotective potential of vidofludimus calcium and back its differentiated profile, gives us a strong foundation from which we hope to ultimately position the drug as a preferred oral therapeutic option that allows MS patients to continue their normal social lives without being reminded that they are on a chronic treatment.”
The ENSURE program comprises twin multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients. Each trial is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, Latin America, Central and Eastern Europe, and India.
Patients will receive either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include volume of new T2-lesions, time to confirmed disability progression, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume, and white matter volume. With regard to the disability progression endpoint, the ENSURE program applies a pooled analysis of disability worsening across both trials, which may be further supported by data from the CALLIPER trial.
An interim analysis to assess event rates is planned to occur after a certain number of relapses have occurred in the double-blind treatment periods. This analysis is intended to inform potential sample size adjustment and help ensure that the final study readout is not planned to occur before sufficient events have been achieved. This interim analysis will also allow for a non-binding futility analysis.