DGAP-News: Immunic, Inc.
/ Key word(s): Study results
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
- Totality of Data Clearly Supports Decision that 30 mg Once Daily Dose of IMU-838 Will Now Be Targeted for Phase 3 Development in Relapsing-Remitting Multiple Sclerosis -
- As Previously Announced, Phase 3 Program Expected to Start in the Second Half of 2021 -
NEW YORK, April 15, 2020 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today 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.
"The positive outcome of the interim analysis of our Cohort 2 sub-trial of IMU-838 in RRMS further strengthens our understanding of the dose-response relationship of IMU-838. The 10 mg interim data and its comparison to the already available 30 mg and 45 mg data provides additional support to address potential regulatory requests in the context of the design and execution of our phase 3 program," commented Andreas Muehler, M.D., Chief Medical Officer of Immunic. "Based on all available data, we believe that the dose of 30 mg once daily IMU-838 should be considered the most appropriate dose for RRMS patients. While we continue our discussions with major regulatory authorities, we will move ahead with formal phase 3 feasibility activities."
"Reporting of this Cohort 2 sub-trial analysis, on time and with results fully matching our expectations, is a testament to the strength of our scientific and clinical teams," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "We look forward to announcing details for the design of our phase 3 program, which we intend to initiate in the second half of this year, as soon as the final regulatory feedback is available. Data thus far continues to convince us that IMU-838 may become an important, new, oral therapeutic option with an outstanding combination of safety, tolerability and robust efficacy for the treatment of patients suffering from RRMS, and we are eager to move ahead with its final clinical development steps."
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15.04.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.