Immunic reports positive data from maintenance phase of phase 2 caldose-1 trial of vidofludimus calcium in moderate-to-severe ulcerative colitis
– 50-week maintenance phase data shows dose-linear increase in clinical remission for vidofludimus calcium as compared to placebo – – 30 mg once-daily dose of vidofludimus calcium demonstrated statistically significant rates of clinical remission (p=0.0358) and endoscopic healing (p=0.0259) at week 50 – – to focus resources on high performing vidofludimus calcium and imu-856 programs, immunic decided to deprioritize izumerogant (imu-935) program – – conference call and webcast to be held today, april 5, 2023 at 8:00 am et – new york , april 5, 2023 /prnewswire/ -- immunic, inc. (nasdaq: imux), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today reported positive 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) (clinicaltrials.gov: nct03341962). the maintenance phase efficacy data at week 50 are as follows: placebo 10 mg imu-838 30 mg imu-838 clinical remission rate1 27.8% (n=5/18) 42.3% (n=11/26) 61.5% (n=16/26) steroid-free clinical remission rate 27.8% (n=5/18) 38.5% (n=10/26) 61.5% (n=16/26) steroid-free clinical remission rate of patients who received corticosteroids during induction phase 27.3% (n=3) 38.5% (n=5) 66.7% (n=8) endoscopic healing rate2 35.3% (n=6/17) 53.6% (n=15/28) 73.1% (n=19/26) as shown above, data from the maintenance phase of caldose-1 showed a dose-linear increase in clinical remission as compared to placebo at week 50.
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