DGAP-News: Immunic, Inc.
/ Key word(s): Conference/Study results
Immunic, Inc. to Present Preclinical Data for Vidofludimus Calcium at the 17th Congress of European Crohn's and Colitis Organization and Announces Blinded Baseline Characteristics of its Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Ulcerative Colitis - Top-Line Data of the CALDOSE-1 Trial Expected to be Available in June of 2022 - NEW YORK, February 18, 2022 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that Evelyn Peelen, Ph.D., Senior Manager Translational Pharmacology at Immunic, will present preclinical data on the potent anti-inflammatory activity of vidofludimus calcium (IMU-838), the company's selective oral DHODH inhibitor, at the 17th Congress of European Crohn's and Colitis Organization (ECCO). The poster, entitled, "Vidofludimus Calcium (IMU-838), a Small Molecule DHODH Inhibitor in Phase 2 Clinical Trial for Ulcerative Colitis, Shows Potent Anti-inflammatory Activity in Cell-Culture-Based Systems" (Abstract Number: EC22-1109, Poster Number: P064), will be presented during the Virtual Poster Exhibition - Basic Science / ePosters being held today. The poster presentation will also be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Highlights include: - Vidofludimus calcium reduces proinflammatory immune cell responses by inducing regulatory macrophages, reducing pro-inflammatory cytokine secretion and reducing T cell proliferation. - Vidofludimus calcium shows an additive to synergistic effect with anti-TNF antibodies in a mixed lymphocyte reaction assay, suggesting a new and promising potential combination treatment opportunity for ulcerative colitis (UC). - DHODH is important in cells that receive a strong immune stimulus and are highly metabolically active. In support, vidofludimus calcium was observed to show a biological selectivity by only targeting these hyperactive cells and, thus, allows for a normal immune response against pathogens and towards vaccines, representing a medically relevant advantage for treatment of patients with inflammatory bowel disease. Additionally, Immunic announces the blinded baseline characteristics of its phase 2 CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC. In October 2021, Immunic announced the completion of enrollment of the trial. At completion of patient recruitment, the trial had randomized a total of 263 patients into four arms: three active dosing arms of 10 mg, 30 mg and 45 mg, as well as placebo. Top-line data for the induction phase is expected to be available in June of 2022. The main blinded baseline characteristics of the CALDOSE-1 trial include: - 263 moderate-to-severe UC patients were enrolled in 78 study sites with the Ukraine and Poland representing the countries with highest number of patients and U.S. sites contributing 12.5% of the overall enrollment. - Of the 263 patients, 148 (56.3%) were male and 115 (43.7%) were female patients. The mean age at baseline was 41.7 (18-77) years. - All patients had to have failed at least one prior therapy option. Of the 263 patients, 83% were biologically naïve and 17% were biologically experienced (received at least 1 prior treatment with any biological agent approved in the UC indication). - Enrolled patients had to show evidence of active moderate-to-severe UC disease. This is reflected in their baseline characteristics for patient-reported outcomes: - The baseline Mayo stool frequency scores were: (i) score of 3 for 59% of patients, (ii) score of 2 for 36% patients and (iii) score of 1 for 5% of patients. - The Mayo rectal bleeding scores were: (i) score of 3 in 10% of patients, (ii) score of 2 for 54% of patients and (iii) score of 1 for 31% of patients. - The average value for fecal calprotectin at baseline was approximately 1,320 µg/g for currently available, yet incomplete data. - The trial employed a central independent reader to evaluate the endoscopic eligibility criteria and the following modified Mayo endoscopic scores were assessed at baseline: - 55% of patients with a score of 3; and - 45% of patients with a score of 2. - At week 10 (the time point of the primary efficacy analysis), an adjudication procedure was used for endoscopy assessments. In the case of disagreement between two independent readers, a third independent reader was used for adjudication. Immunic believes that these blinded baseline characteristics of randomized patients and the methodology regarding endoscopic assessments contributes to ensuring an optimized study read-out. About Vidofludimus Calcium (IMU-838) About Immunic, Inc. Cautionary Statement Regarding Forward-Looking Statements Contact Information US IR Contact US Media Contact 18.02.2022 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
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