other material
confidence high
sentiment positive
materiality 0.85
Immunic's vidofludimus calcium reduces disability worsening risk by 30% in PPMS from phase 2 CALLIPER trial
IMMUNIC, INC.
- Vidofludimus calcium reduced 24-week confirmed disability worsening risk by 20% overall (n=467) vs placebo.
- In PPMS subgroup (n=152), risk reduced by 30%; in non-active SPMS (n=268) by 15%.
- Reduced annualized thalamic brain volume loss by 20% vs placebo; T2 lesion burden improved.
- Safety profile consistent with prior trials: TEAEs 69.4% (drug) vs 68.5% (placebo); SAEs 8.1% vs 6.5%.
- Company plans to discuss phase 3 registration path with healthcare authorities.