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Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at ACTRIMS Forum 2023
– Long-Term Open-Label Treatment With Vidofludimus Calcium Was Associated With a Low Rate of Confirmed Disability Worsening (CDW) Over Time – – CDW Data
About this update from Immunic, Inc.
[{"type":"text","content":"– Long-Term Open-Label Treatment With Vidofludimus Calcium Was Associated With a Low Rate of Confirmed Disability Worsening (CDW) Over Time –\n– CDW Data Compares Favorably to Historical Trial Data for Currently Available Multiple Sclerosis Treatments –\nNEW YORK, Feb. 22, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced that Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio, will present data from the blinded and open-label extension (OLE) parts of the company's phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), a selective oral DHODH inhibitor, in relapsing-remitting multiple sclerosis (RRMS) at the eighth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023, taking place February 23-25 in San Diego, California. Dr. Fox has served as Coordinating Investigator in Immunic's multiple sclerosis (MS) programs and receives consulting fees for serving as an advisor to Immunic.\n\"The encouraging data from the 24-week double-blind main treatment period of the phase 2 EMPhASIS trial of vidofludimus calcium in RRMS patients showed that 12-week and 24-week Confirmed Disability Worsening (CDW) events occurred in 1.6% of subjects in the combined vidofludimus calcium treatment arms as compared to 3.7% in the placebo group,\" stated Dr. Fox. \"Additionally, in the OLE phase, the proportion of patients free from 12-week CDW was 97.2% after 48 weeks and 94.2% after 96 weeks of vidofludimus calcium treatment, as measured from the start of the OLE phase. Similarly, 97.6% of patients were free from 24-week CDW after 48 weeks and 94.5% after 96 weeks.\"\n\"The opportunity to present data from our EMPhASIS trial at the ACTRIMS Forum 2023 is of high relevance for Immunic, allowing us to further highlight to the industry the potential of vidofludimus calcium in RRMS, especially as the CDW rates seen in this trial were on the lower end of those observed in historical trials with currently approved MS medications,\" added Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"We eage...