Immunic (NASDAQ:IMUX) announced positive Phase 2 CALLIPER data demonstrating its nuclear receptor related 1 (Nurr1) activator—vidofludimus calcium (IMU-838)—reduced the risk of progressive multiple sclerosis (PMS) worsening by 30%.
According to Immunic, reduction of confirmed disability worsening is widely considered to be the most recognized regulatory approval endpoint for registrational studies in progressive forms MS.
In a statement, Daniel Vitt, Ph.D., CEO of Immunic, commented, “The tremendous reduction of confirmed disability worsening in PMS patients is a wonderful confirmation of the objectives of this exploratory Phase 2 trial. CALLIPER was designed to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of PMS patients to determine the suitability of advancing to a confirmatory Phase 3 program.”
“We are particularly thrilled to see such a clinically meaningful effect in the primary PMS (PPMS) population, with a 30% reduction in the relative risk of 24-week confirmed disability events, which would be the endpoint of a future Phase 3 registration study, outperforming historic trials in PPMS regarding numerical reduction of disability progression events.”
Dr. Vitt concluded, “We believe that vidofludimus calcium may represent a novel and exciting approach for people living with PMS, where there continues to be a huge unmet medical need given only one approved therapy. We look forward to discussing these results with healthcare authorities to determine appropriate next steps for vidofludimus calcium in PMS.”
