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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
About this update from Immunic, Inc.
[{"type":"text","content":"– 50-Week Maintenance Phase Data Shows Dose-Linear Increase in Clinical Remission for Vidofludimus Calcium as Compared to Placebo –\n– 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 –\n– To Focus Resources on High Performing Vidofludimus Calcium and IMU-856 Programs, Immunic Decided to Deprioritize Izumerogant (IMU-935) Program –\n– Conference Call and Webcast to be Held today, April 5, 2023 at 8:00 am ET –\nNEW 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:\nPlacebo\n10 mg IMU-838\n30 mg IMU-838\nClinical remission rate1\n27.8%\n(N=5/18)\n42.3%\n(N=11/26)\n61.5%\n(N=16/26)\nSteroid-free clinical remission rate\n27.8%\n(N=5/18)\n38.5%\n(N=10/26)\n61.5%\n(N=16/26)\nSteroid-free clinical remission rate of patients who received corticosteroids during induction phase\n27.3%\n(N=3)\n38.5%\n(N=5)\n66.7%\n(N=8)\nEndoscopic healing rate2\n35.3%\n(N=6/17)\n53.6%\n(N=15/28)\n73.1%\n(N=19/26)\nAs 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. Moreover, 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 placebo. A similar effect on clinical remission rates at week 50 was also found among those patients who received corticosteroids during the induction phase. Finally, 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 placebo and also achieving statistical significance in an exploratory statistical analysis (p=0.0259).\nImmunic believes that the maintenance phase data of CALDOSE-1 confirms vidofludimus calciu...