- 92.3% of patients remained free of 12-week confirmed disability worsening (CDW) and 92.7% remained free of 24-week CDW at Week 144.
- Vidofludimus calcium maintains a favorable safety profile with no new safety signals over 5.5 years.
- 71.6% patient retention in the open-label extension trial, representing approximately 952 treatment years.
Immunic Inc. (IMUX, Financial) has released promising results from its Phase 2 EMPhASIS trial's open-label extension (OLE) examining vidofludimus calcium in relapsing-remitting multiple sclerosis (RRMS) patients. At week 144, 92.3% of participants showed no confirmed disability worsening (CDW) over 12 weeks, and 92.7% were free of 24-week CDW.
The study, representing approximately 952 treatment years, highlighted that of the 29 CDW events confirmed at 12 weeks, 44.8% were linked to relapse-associated worsening, while only 13.8% were associated with progression independent of relapse activity. Vidofludimus calcium demonstrated a strong safety record, with low discontinuation rates and no new safety concerns emerging during the 5.5-year trial period.
The trial's retention rate was high, with 71.6% of patients from the OLE period being assessed at week 144, underlining the drug's tolerance and potential benefits. Vidofludimus calcium, administered orally, provides patients with a convenient alternative to injectable therapies, significantly impacting the long-term management of multiple sclerosis by potentially delaying disability progression and improving quality of life.
