Immunic Reports P-IIb Study (CALDOSE-1) Results of IMU-838 (vidofludimus calcium) for Moderate-to-Severe Ulcerative Colitis
Shots:
- The P-IIb dose-finding study evaluates vidofludimus calcium vs PBO in patients at 78 study sites in the US and EU
- The 50wk. maintenance phase results showed a dose-linear increase in clinical remission, 10 & 30mg, qd of vidofludimus calcium showed clinical remission rate (42.3% & 61.5% vs 27.8%); steroid-free clinical remission rate (38.5% & 61.5% vs 27.8%); steroid-free clinical remission rate of patients who received corticosteroids during the induction phase (38.5% & 66.7% vs 27.3%) & endoscopic healing rate (53.6% & 73.1% vs 35.3%)
- The therapy was well tolerated with no new safety signals, the incidence of TEAEs was comparable with PBO, and no increased rates of liver events, liver enzyme elevations, renal events, or AEs of special interest were seen
Ref: Immunic, Inc. | Image: Immunic, Inc.
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