Immunic Inc (NASDAQ:IMUX) has published extended data from its Phase 2 EMPhASIS trial of its lead asset vidofludimus calcium in relapsing-remitting Multiple Sclerosis (RRMS) in the peer-reviewed journal Neurology, Neuroimmunology and Neuroinflammation, an official journal of the American Academy of Neurology.
Immunic is developing its small molecule investigational drug vidofludimus calcium as an oral treatment option for patients with MS and other chronic inflammatory and autoimmune diseases.
After doses of 30mg and 45mg of vidofludimus calcium showed “robust activity” on multiple endpoints, the EMPhASIS trial enrolled patients to receive a lower dose of vidofludimus calcium to further investigate the dose-response relationship by extending the trial to a broader dose range.
Study cohort 2 explored a 10mg dose versus placebo.
The newly published paper, titled "Safety and Dose-Response of Vidofludimus Calcium in Relapsing Multiple Sclerosis: Extended Results of a Placebo-Controlled Phase 2 Trial,” was authored by coordinating investigator Dr Robert Fox.
It details the extended results from the pooled EMPhASIS data from cohorts 1 and 2, including the comparison to the pooled placebo group from both study cohorts.
The pooled data showed that vidofludimus calcium in 30mg and 45mg daily doses supported the development of new combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24 by 76% and 71%, respectively.
It suppressed the development and gadolinium-enhancing lesions by 78% to 74% compared to the pooled placebo at 24 weeks.
The improvements in serum neurofilament light chain (NfL), which is thought to correlate with neuronal destruction, decreased in a dose-dependent manner.
It decreased by 9% for the 10mg cohort, 18% for the 30mg cohort and 26% for the 45mg cohort, which Immunic said suggests NfL has a different dose-response pattern.
Dr Daniel Vitt, Immunic's CEO, highlighted that the publication of the company’s Phase 2 EMPhASIS trial results for both study cohorts with an extended dose range represented “further evidence of the strength of these findings for vidofludimus calcium in patients with RRMS.”
"As reported, a dose-dependent effect of vidofludimus calcium on the suppression of new CUA MRI lesions as well as gadolinium-enhancing lesions was demonstrated along with an encouraging initial signal towards reducing 12-week and 24-week confirmed disability worsening events as compared to placebo during the double-blind treatment period,” Vitt said.
“The findings impressively underline the drug's combined neuroprotective and anti-inflammatory effects.”
Vitt added that the company continues to enroll patients in its twin Phase 3 ENSURE trials of its lead asset in relapsing multiple sclerosis.
“We expect to report an interim futility analysis in late 2024, with the top-line readout of the first of the ENSURE trials anticipated in the second quarter of 2026,” he said.