Immunic's Vidofludimus Calcium Shows Long-Term Efficacy in RRMS Treatment

Immunic Inc released new long-term data from a study on its experimental drug, vidofludimus calcium, which continues to help patients with relapsing-remitting multiple sclerosis (RRMS) over time. The data showed that 92.3% of patients remained free of 12-week confirmed disability worsening and 92.7% free of 24-week CDW at week 144. The drug demonstrated a favorable safety profile over long-term use, with no new safety signals emerging. Immunic CEO Dr Daniel Vitt believes vidofludimus calcium has the potential to address the unmet need of slowing and preventing disease progression in RRMS.

Immunic, Inc. (Nasdaq: IMUX) has released new long-term data from its phase 2 EMPhASIS trial, demonstrating the potential of its experimental drug, vidofludimus calcium (IMU-838), in managing relapsing-remitting multiple sclerosis (RRMS). The data, presented at week 144, showed that 92.3% of patients remained free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW. This indicates a low rate of disability progression, an important unmet need in RRMS despite existing treatments [1].

The drug has shown a favorable safety and tolerability profile over long-term use, with no new safety signals emerging during the 5.5-year treatment period. This is significant as it suggests that vidofludimus calcium can be safely administered over extended periods, which is crucial for chronic conditions like RRMS [1].

The CEO of Immunic, Dr. Daniel Vitt, expressed optimism about the potential of vidofludimus calcium to address the critical need for slowing and preventing disease progression in RRMS. The drug's unique dual mode of action—neuroprotective, anti-inflammatory, and anti-viral effects—targets the complex pathophysiology of MS, offering a promising approach to managing the disease [1].

The phase 2 EMPhASIS trial, an international, multicenter study, randomized 268 RRMS patients to receive vidofludimus calcium or placebo. The trial achieved both primary and key secondary endpoints, and the long-term open-label extension (OLE) period has provided valuable insights into the drug's efficacy and safety over extended periods [1].

Immunic's pipeline includes other small molecule therapies for chronic inflammatory and autoimmune diseases, with IMU-856 targeting intestinal barrier function and IMU-381 in preclinical testing for gastrointestinal diseases [1]. The company's lead asset, vidofludimus calcium, is currently in phase 3 clinical trials for the treatment of relapsing MS, with top-line data expected by the end of 2026.

References:
[1] https://www.biospace.com/press-releases/immunic-reports-new-positive-long-term-open-label-extension-data-from-phase-2-emphasis-trial-of-vidofludimus-calcium-in-relapsing-remitting-multiple-sclerosis