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Immunic, Inc. Reports Top-Line Data from Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Patients with Moderate-to-Severe Ulcerative Colitis and Provides Corporate Update
– Trial Did Not Achieve Primary Endpoint in the Ulcerative Colitis (UC) Population Caused by Unexpected Interference Between Vidofludimus Calcium and
About this update from Immunic, Inc.
[{"type":"text","content":"– Trial Did Not Achieve Primary Endpoint in the Ulcerative Colitis (UC) Population Caused by Unexpected Interference Between Vidofludimus Calcium and Concurrent Use of Corticosteroids –\n– In UC Population Without Concurrent Steroid Use, Pooled Vidofludimus Calcium Data Suggest Activity in Clinical Remission Over Placebo; Counterbalanced by Interference Observed in the UC Population with Concurrent Steroid Use –\n– Company Does Not Plan Further Development Activities in Ulcerative Colitis Without a Partner –\n– Focus to Remain on Ongoing Phase 3 Development of Vidofludimus Calcium in Multiple Sclerosis, and Ongoing IMU-935 and IMU-856 Programs with Clinical Data for Both Expected in 2022 –\n– $93.1 Million in Cash and Cash Equivalents as of May 31, 2022 Expected to Fund Immunic Into the Fourth Quarter of 2023 –\n– Conference Call and Webcast, Including a Corporate Update, to be Held today, June 2, 2022 at 8:00 am ET –\nNEW YORK, June 2, 2022 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today reported top-line data from its phase 2 CALDOSE-1 trial of lead asset, vidofludimus calcium (IMU-838), the company's selective oral DHODH inhibitor, in patients with moderate-to-severe ulcerative colitis (UC) (clinicaltrials.gov: NCT03341962).\nThe trial did not achieve the primary endpoint of clinical remission for the pooled 30 and 45 mg/day active dose groups of vidofludimus calcium versus placebo at week 10. In addition, no meaningful differences were observed between the three active dose groups for the overall intent-to-treat patient population (10 mg/day: 14.9%, 30 mg/day: 10.6%, 45 mg/day: 13.6%, placebo: 12.5%) or for the trial's other secondary endpoints, including symptomatic remission, or endoscopic healing.\nConsistent with prior data sets in other patient populations, administration of vidofludimus calcium in this trial was observed to be safe and well-tolerated. No new safety signals were observed. As compared to placebo, there were no increased rates of infections and infestations, no elevated rates of liver events or liver enzyme elevations, and no elevated rates for changes in hematology-related laboratory variables. The most common adverse events in this ...