Immunic will continue developing its multiple sclerosis (MS) drug, vidofludimus calcium (IMU-838), despite a Phase II trial missing its primary endpoint.
Topline data from the ongoing CALLIPER study (NCT05054140) of vidofludimus calcium showed modest benefit on an exploratory primary MRI endpoint reporting a 5% annualised rate of percent brain volume change compared to placebo.
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The company added that vidofludimus calcium substantially reduced the annualised rate of thalamic brain volume loss by 20% in patients with PMS compared to placebo.
The drug reduced the relative risk of 24-week confirmed disability worsening (24wCDW) events based on changes in the expanded disability status scale (EDSS) by 20% compared to placebo. There was even more benefit seen in a subgroup of patients, with a 30% reduction in the relative risk of 24wCDW events in the primary progressive MS study population compared to placebo and a respective 15% reduction in the non-active secondary progressive MS population.
CEO of Immunic, Dr. Daniel Vitt, remained positive about the results despite the MRI endpoint miss. Vitt said: “We are particularly thrilled to see such a clinically meaningful effect in the PPMS population, with a 30% reduction in the relative risk of 24-week confirmed disability worsening events, which would be the endpoint of a future Phase III registration study, outperforming historic trials in primary progressive MS regarding numerical reduction of disability progression events.”
The top-line data confirmed the drug remained safe and tolerable in the study, with no new safety signals identified.
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By GlobalDataThe ongoing study will continue to evaluate the nuclear receptor related 1 (Nurr1) activator’s efficacy and safety in 467 patients. The trial’s open-label extension phase may continue for up to eight years.
The biotech has two ongoing Phase III trials (NCT05134441 and NCT05201638) of the drug candidate in patients with relapsing MS, which is expected to complete in 2026. This was initiated shortly after the Phase II EMPhASIS trial (NCT03846219) met its primary and key secondary endpoints.
Earlier this year, Roche announced that a Phase III trial (NCT04544436) evaluating high-doses of its intravenous (IV) Ocrevus (ocrelizumab) in patients with relapsing MS failed to meet its primary endpoint. The US Food and Drug Administration (FDA) first approved Ocrevus in March 2017 as the first product approved for primary progressive MS.
