Immunic Announces Publication of Data from its Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis in the Peer-Reviewed Journal, Annals of Clinical and Translational Neurology

NEW YORK, June 15, 2022 /PRNewswire/ — immuneInc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on the treatment of chronic inflammatory and autoimmune diseases, today announced that data from its EMPhASIS Phase 2 trial of lead asset, vidofludimus calcium (IMU-838), in patients with relapsed remitting multiple sclerosis (RRMS), was published in the peer-reviewed journal, Annals of Clinical and Translational Neurology.

The article, written by the coordinating investigator, Robert J. FoxMD, Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice President of Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohiois titled, “Safety and efficacy of vidofludimus calcium, a selective dihydroorotate dehydrogenase inhibitor, in relapsing-remitting multiple sclerosis (EMPhASIS): a double-blind, randomized, placebo-controlled phase 2 trial. It is accessible via the following link: https://onlinelibrary.wiley.com/doi/10.1002/acn3.51574.

Vidofludimus calcium is a novel second-generation selective dihydroorotate dehydrogenase (DHODH) inhibitor with no off-target effects on kinases seen with drugs in the same class, which may lead to an improved safety and tolerability profile. Inhibition of DHODH has been shown to suppress magnetic resonance imaging (MRI) brain damage and disease activity in multiple sclerosis. The article assessed safety and potency on MRI-based endpoints as well as clinical and biomarker assessments of vidofludimus calcium in patients with RRMS.

“The results of this Phase 2 trial of vidofludimus calcium in patients with RRMS are encouraging, as the trial met its key primary and secondary endpoints for suppression of imaging combined lesion counts. unique active magnetic resonance scans,” said Dr. Fox. “Importantly, vidofludimus calcium was shown to be safe and well tolerated compared to placebo, with no increased rate of infections, effects on liver or blood cell laboratory parameters and with a very low treatment drop-out rate. Dr. Fox receives consulting fees for his advisory work with Immunic.

“The publication of the EMPhASIS trial results in a peer-reviewed journal demonstrates the importance of our Phase 2 findings for vidofludimus calcium in patients with RRMS,” said Daniel Vitt, Ph.D., CEO and President of Immunic. “Based on these strong data, we enrolled patients in our Phase 2 CALLIPER trial in patients with progressive multiple sclerosis to further explore the neuroprotective potential of vidofludimus calcium, as evidenced by the slowing of cerebral atrophy and delayed worsening of disability, which are often caused by axonal diseases and neural damage Equally exciting, we have also enrolled patients in our ENSURE Phase 3 program of vidofludimus calcium as a treatment relapsing multiple sclerosis (MS). We remain very excited about the potential of this new treatment to become a best-in-class DHODH inhibitor – in the RMS.”

Full plain data from the Phase 2 double-blind, placebo-controlled EMPhASIS trial (cohort 1 with 30 and 45 mg vidofludimus calcium or placebo once daily) was reported by Immunic in September 2020 and is summarized in more detail in this peer-reviewed journal. The trial met all key primary and secondary endpoints. In particular, the study met its primary endpoint, demonstrating a statistically significant reduction in the cumulative number of unique active combined MRI lesions (AUC) through week 24 in patients receiving 45 mg of vidofludimus calcium once daily. day, by 62% (p = 0.0002), compared to the placebo. The study also met its key secondary endpoint, showing a statistically significant reduction in cumulative AUC MRI lesion count for the 30 mg once daily dose by 70% (p

Earlier in 2022, Immunic published data from a second lower dose cohort of the EMPhASIS trial in RRMS (cohort 2: 10 mg vidofludimus calcium or placebo once daily) that Immunic has l intend to summarize in a future publication. In the final Cohort 2 dataset, the anti-inflammatory effects of vidofludimus calcium at a dose of 10 mg were observed to be weaker (13% reduction in gadolinium-enhancing magnetic resonance imaging lesions up to at 24 weeks, versus placebo) than those found with the 30 mg dose of vidofludimus calcium in the pooled data from Cohorts 1 and 2 (78% reduction), providing further support for dose selection of 30 mg in the ongoing ENSURE trials in the RMS.

About Vidofludimus Calcium (IMU-838)

Vidofludimus Calcium is an investigational drug in development as a next-generation, orally available, selective immune modulator designed to inhibit the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium has been observed to act on activated T and B cells while leaving other immune cells largely unchanged and allowing the immune system to continue to function, for example to fight infections. In previous trials, vidofludimus calcium did not show an increased rate of infections compared to placebo. Additionally, DHODH inhibitors, such as vidofludimus calcium, are known to possess a host-based antiviral effect, which is independent of specific viral proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against several viruses. To date, vidofludimus calcium has been tested in over 1,100 people and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium 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 focused on treating chronic inflammatory and autoimmune diseases. The Company is developing three small molecule products: its lead development program, vidofludimus calcium (IMU-838), a selective immune modulator that inhibits intracellular metabolism of activated immune cells by blocking the DHODH enzyme and exhibits an antiviral effect host-based, is currently being developed as a treatment option for multiple sclerosis and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor RORγ/RORγt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barré syndrome. IMU-856, which targets the restoration of gut barrier function, is targeted for development in diseases involving gut barrier dysfunction. For more information, visit: www.imux.com.

Caution 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 fact, included in this press release regarding strategy, future operations, future financial condition, future revenues, projected expenses, timing and expected results of clinical trials, outlook, plans and objectives of management are forward-looking statements . Examples of such statements include, but are not limited to, statements relating to Immunic’s three development programs and target diseases; the potential of vidofludimus calcium to target disease safely and effectively; preclinical and clinical data for vidofludimus calcium; the schedule of current and future clinical trials and anticipated clinical milestones; the nature, strategy and direction of the business and other updates thereto; and the development and commercial potential of any of the Company’s product candidates. Immunic may not actually achieve the plans, achieve the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on such forward-looking statements. These statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements due to numerous factors, including, but not limited to, the COVID-19 pandemic, risks and uncertainties associated with the ability to project the use future liquidity and reserves necessary for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of preclinical studies and prior clinical trials may not not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, the risks associated with the drug development and regulatory approval process, and the impact of competing products and technological changes. A list and additional descriptions of these risks, uncertainties and other factors can be found in the section titled “Risk Factors” of the Company’s Annual Report on Form 10-K for the fiscal year ended. December 31, 2021filed with the SEC on February 24, 2022, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statements made in this release speak only as of the date of this release. Immunic disclaims any intention or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims any liability for actions taken or not taken based on any or all of the content of this press release.

Contact information

Immunic, Inc.
Jessica Breu
Head of Investor Relations and Communication
+49 89 2080 477 09
jessica.breu@imux.com

US IR contact
Rx Communications Group
Paula Schwartz
+1 917 322 2216
immunic@rxir.com

Contact with the media in the United States
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Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com

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