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 2021-04-15 / 12:30 The issuer is solely responsible for the content of this announcement. =---------------------------------------------------------------------------------------------------------------------- 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 - Preplanned Interim Analysis of 12-Week MRI Data from 10 mg IMU-838 Dose and Placebo, in Combination with Existing 30 and 45 mg Dose Data, Establishes Clear Dose-Response Relationship for IMU-838 - - 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." About Relapsing-Remitting Multiple Sclerosis Multiple sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve. In MS, myelin, the coating that protects the nerves, is attacked and damaged by the immune system. Thus, MS is considered an immune-mediated demyelinating disease of the central nervous system. Relapsing-remitting MS (RRMS) is the most common form of the disease. Approximately 85% of patients with MS are expected to develop RRMS, with some of these patients later developing more progressive forms of the disease. RRMS is characterized by clearly defined attacks of new or increasing neurologic symptoms. These relapses are followed by periods of remission, or partial or complete recovery. During remissions, all symptoms may disappear, or some symptoms may continue and become permanent. MS is a progressive disease which, without effective treatment, leads to severe disability. MS affects more than 700,000 people in the United States, and more than 2.2 million people worldwide. The disease mainly affects young adults of prime working age, although MS can occur at any age. MS is at least two to three times more common in women than in men. About IMU-838 IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors, such as IMU-838, are known to possess a host-based antiviral effect, which is independent with respect to specific virus proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in a phase 2 trial in patients with ulcerative colitis. In the third quarter of 2020, the company reported positive results from its phase 2 EMPhASIS trial of IMU-838 in relapsing-remitting multiple sclerosis, achieving both primary and key secondary endpoints with high statistical significance. In the first quarter of 2021, Immunic announced that IMU-838 showed evidence of clinical activity in its phase 2 CALVID-1 trial in hospitalized patients with moderate COVID-19. Also, in the first quarter of 2021, the company reported positive top-line data from an investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in primary sclerosing cholangitis which was conducted in collaboration with Mayo Clinic. To date, IMU-838 has been tested in more than 800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. IMU-838 is not yet licensed or approved in any country. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, IMU-838, a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis, ulcerative colitis, Crohn's disease, COVID-19, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR?t, is targeted for development in psoriasis and Guillain-Barré syndrome. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. For further information, please visit: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements relating to Immunic's three development programs and the targeted diseases; the potential for IMU-838 to safely and effectively target diseases, including relapsing-remitting multiple sclerosis; preclinical and clinical data for IMU-838; the timing of current and future clinical trials; the availability, safety or efficacy of potential treatment options for patients with relapsing-remitting multiple sclerosis or other
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