US-based biotech Immunic has unveiled data from the Phase II CALDOSE-1 trial of vidofludimus for the treatment of moderate to severe ulcerative colitis.   

Data showed that the induction phase did not achieve the primary endpoint of clinical remission for the total population. In data presented at the United European Gastroenterology Week 2023 on 14-17 October, it is thought that this may be due to interactions with corticosteroids started just before randomisation.  

A dose-linear increase in clinical remission was seen at the maintenance phase, the point at which concomitant corticosteroids were mandatorily tapered. Patients treated with vidofludimus achieved dose-linear increases in steroid-free clinical remission, endoscopic healing, and microscopic healing. 

The CALDOSE-1 trial, which enrolled 263 patients, is a multicentre, randomised, double-blind, placebo =-controlled, dose-finding study that included a blinded ten-week induction phase and a blinded 50-week maintenance phase. 

Vidofludimus is a small molecule investigational drug that inhibits the enzyme dihydroorotate dehydrogenase (DHODH), a key enzyme in immune function.  

Professor at Amsterdam University Medical Centers Geert D’haens said: “The maintenance phase results of the Phase IIb CALDOSE-1 trial demonstrate statistically significant activity of vidofludimus calcium compared to placebo and reaffirm the drug’s favourable safety and tolerability profile. The data, therefore, validates the potential of vidofludimus in UC and other inflammatory bowel disease indications.” 

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Last week, Immunic unveiled data from the Phase II EMPhASIS trial evaluating the safety and efficacy of vidofludimus in patients with relapsing-remitting multiple sclerosis (RRMS). The study, which enrolled 268 patients, achieved both primary and secondary endpoints with high statistical significance.  

According to GlobalData, vidofludimus’ sales forecast are estimated to reach $777m in 2029. GlobalData is the parent company of Clinical Trials Arena.