Immunic, Inc. Announces EMPhASIS Interim Analysis of 10 mg Cohort Confirms IMU-838's Dose Response in Relapsing-Remitting Multiple Sclerosis and Supports Phase 3 Dose Selection
April 15, 2021 at 06:30 am
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Immunic, Inc. announced interim data from Cohort 2 of its phase 2 EMPhASIS trial of IMU-838 in relapsing-remitting multiple sclerosis (RRMS). Immunic has concluded from this data, along with previously published data from Cohort 1, that 30 mg once daily IMU-838 is the most appropriate dose for future phase 3 trials in patients with RRMS. In support, Immunic notes that both the 30 mg and 45 mg dosing groups of IMU-838 in Cohort 1 performed equivalently regarding efficacy-related endpoints and there was no safety signal for either dosing group, as compared to placebo. The second cohort of the EMPhASIS trial was designed to confirm that a dose lower than the 30 mg and 45 mg daily dose groups studied in the first cohort was unlikely to match the efficacy seen in these higher doses, thus enabling a straightforward and simpler phase 3 design. As anticipated, the 10 mg dose of IMU-838 proportionally showed less magnetic resonance imaging (MRI) lesion suppression in RRMS than the previously published results of the 30 mg and 45 mg doses of IMU-838. In particular, the 10 mg dose of IMU-838 in Cohort 2 demonstrated a placebo-adjusted reduction of 32% and 40% in combined unique active and gadolinium-enhancing MRI lesions at week 12, respectively. This result is numerically lower than the analogous reduction in MRI lesions observed in the 30 mg and 45 mg IMU-838 dosing arms of Cohort 1 at week 12, which ranged between 62% and 75%. Collectively, Immunic believes that these data demonstrate a clear dose-response pattern for IMU-838 in RRMS. The Cohort 2 interim analysis was performed after 59 randomized patients, receiving either 10 mg of IMU-838 or placebo once daily, completed week 12 MRI assessments. All Cohort 2 patients continue to be treated and will proceed to complete their 24-week blinded treatment. Immunic remains in discussions with regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, regarding the planned phase 3 program in RRMS. At the FDA's request, Immunic plans to proceed directly to submitting an Investigational New Drug (IND) application, instead of holding an end-of-phase 2 meeting. As previously announced, feasibility and other preparatory activities for the phase 3 program are already ongoing and initiation is expected in the second half of 2021.
Immunic, Inc. is a biotechnology company. The Company is focused on developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The Companyâs s lead development program, vidofludimus calcium (IMU-838), is in phase III and phase II clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase II clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis. IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease. IMU-381 is in preclinical testing, a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.