Immunic, Inc. (NASDAQ:IMUX), a leading biotech company, has recently unveiled promising results from its phase 2 clinical trials at the ACTRIMS Forum 2024. The trials focused on investigating the efficacy of vidofludimus calcium, a potential therapy for progressive multiple sclerosis (PMS) and its impact on fatigue possibly linked to Epstein-Barr virus (EBV) reactivation in multiple sclerosis (MS) patients.

The interim analysis of the phase 2 CALLIPER trial revealed a substantial reduction in serum neurofilament light chain (NfL) levels, a key biomarker for neuronal damage, in PMS patients treated with vidofludimus calcium compared to placebo. The treatment group experienced a notable 22.4% decrease in serum NfL, indicating the drug’s potential neuroprotective benefits alongside its anti-inflammatory properties. Top-line data from the CALLIPER trial is anticipated in April 2025.

In addition, the phase 2 CALVID-1 trial, initially focused on COVID-19 patients, suggested that vidofludimus calcium may prevent the reactivation of EBV, potentially alleviating fatigue, a prevalent symptom in MS patients. Patients treated with the drug exhibited a lower frequency of post-COVID fatigue compared to those receiving a placebo. These findings could signify a novel approach to managing fatigue in MS patients, pending further confirmation in ongoing phase 3 ENSURE trials.

Vidofludimus calcium (IMU-838), Immunic’s lead development program, is currently undergoing phase 3 and phase 2 clinical trials for relapsing and progressive MS, respectively. As a first-in-class nuclear receptor related 1 (Nurr1) activator with neuroprotective effects, the drug has demonstrated promise in earlier trials for various autoimmune conditions. The company is striving to confirm the drug’s ability to influence fatigue and EBV reactivation in its ongoing phase 3 ENSURE trials in relapsing MS patients. Detailed poster presentations on these findings will be accessible on Immunic’s website.

These groundbreaking results mark a significant stride in Immunic’s clinical pipeline, underscoring its commitment to addressing unmet medical needs in chronic inflammatory and autoimmune diseases.