NEW YORK - Immunic, Inc. (NASDAQ:IMUX), a biotech company focused on developing treatments for chronic inflammatory and autoimmune diseases, has presented new data from its phase 2 clinical trials at the ACTRIMS Forum 2024.
The trials investigate vidofludimus calcium, a potential therapy for progressive multiple sclerosis (PMS) and a separate study on its effects on fatigue possibly linked to Epstein-Barr virus (EBV) reactivation in multiple sclerosis (MS) patients.
The phase 2 CALLIPER trial interim analysis revealed a significant reduction in serum neurofilament light chain (NfL) levels, a biomarker for neuronal damage, in PMS patients treated with vidofludimus calcium compared to placebo.
The treatment group saw a 22.4% decrease in serum NfL, with reductions observed across all PMS subtypes. This suggests the drug's potential neuroprotective benefits in addition to its anti-inflammatory properties. Top-line data from the CALLIPER trial is expected in April 2025.
Additionally, the phase 2 CALVID-1 trial, which initially focused on COVID-19 patients, indicated that vidofludimus calcium might prevent the reactivation of EBV, which has been associated with fatigue, a prevalent symptom in MS patients.
The trial showed a lower frequency of post-COVID fatigue in patients treated with the drug compared to those receiving a placebo. These findings may point to a new approach in managing fatigue in MS patients, pending further confirmation in ongoing phase 3 ENSURE trials.
Immunic's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for relapsing and progressive MS, respectively. The drug is a first-in-class nuclear receptor related 1 (Nurr1) activator with neuroprotective effects and has shown promise in earlier trials for various autoimmune conditions.
The company aims to confirm the ability of vidofludimus calcium to influence fatigue and EBV reactivation in its ongoing phase 3 ENSURE trials in relapsing MS patients. The poster presentations detailing these findings will be available on Immunic's website.
This article is based on a press release statement from Immunic, Inc. The company is advancing its clinical pipeline with a focus on addressing unmet medical needs in chronic inflammatory and autoimmune diseases.
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