After Positive Data In Ulcerative Colitis Study, Immunic Prioritizes Vidofludimus Calcium Program With One More Candidate

  • Immunic, Inc IMUX reported data from the maintenance phase of its phase 2b CALDOSE-1 trial of lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC).
  • Data showed a dose-linear increase in clinical remission as compared to placebo at week 50. 
  • An exploratory statistical analysis confirmed the 30 mg dose of vidofludimus calcium to be statistically superior (p=0.0358) in achieving clinical remission at week 50, with a 33.7% absolute improvement over the placebo. 
  • Related: Immunic Touts Positive Vidofludimus Calcium Data In Multiple Sclerosis Candidate.
  • A dose-linear increase in endoscopic healing was observed, with the 30 mg dose of vidofludimus calcium being associated with a 37.8% absolute improvement over the placebo.
  • Immunic says the maintenance phase data of CALDOSE-1 confirms vidofludimus calcium's activity in the absence of chronic corticosteroid co-administration.
  • Immunic has decided to focus its resources on vidofludimus calcium and IMU-856, deprioritizing the clinical portion of its izumerogant development program in psoriasis and castration-resistant prostate cancer.
  • For IMU-856, the part C portion of the ongoing phase 1 trial in celiac disease patients has been proceeding more quickly than anticipated, with initial data expected to become available in the current quarter.
  • Price Action: IMUX shares are up 11% at $1.62 on the last check Wednesday.
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