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Immunic Completes Enrollment of Its Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis
– Unblinded Interim Biomarker Analysis Expected in the Fall of 2023 – – Full Data Readout Expected in April 2025 – NEW YORK, Aug. 17, 2023 /PRNewswire/ --
About this update from Immunic, Inc.
[{"type":"text","content":"– Unblinded Interim Biomarker Analysis Expected in the Fall of 2023 –\n– Full Data Readout Expected in April 2025 –\nNEW YORK, Aug. 17, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the completion of enrollment of its phase 2 CALLIPER trial of lead asset, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). In total, 467 patients with primary PMS, or active or non-active secondary PMS have been randomized to either 45mg of vidofludimus calcium or placebo. The trial, running concurrently and as a complement to the company's twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), is focused on progressive forms of multiple sclerosis (MS) and is designed to corroborate vidofludimus calcium's neuroprotective potential in this patient population.\nAnticipated Milestones for the CALLIPER Trial:\nAn interim analysis comprising unblinded biomarker data, including serum neurofilament light chain (NfL), is expected to be available in the fall of 2023 and will include data for approximately half of the enrolled patients (225) who have completed a follow-up period of at least 24 weeks of study treatment.A top-line data readout of the full 467 patients is now expected in April of 2025.\"Our phase 2 CALLIPER trial is designed to corroborate the neuroprotective potential of vidofludimus calcium in a progressive patient population. Enrollment of the final PMS patient, according to plan, is another important milestone in the clinical development of our lead asset in MS,\" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"We believe that the data from the CALLIPER trial, along with that from our ENSURE program, in conjunction with vidofludimus calcium's postulated neuroprotective effects as a first-in-class nuclear receptor related 1 (Nurr1) activator as well as its strong safety and tolerability profile shown, to date, may further strengthen the uniqueness of this treatment approach compared to other oral MS medications and result in a highly attractive commercial positioning.\"\n\"As reported in May of this year, in preclinical testing, we have discovered strong Nurr1 agonism by vidofludimus calcium. ...