First Patient Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of Vidofludimus Calcium in Patients with Post COVID Syndrome

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NEW YORK, Sept. 4, 2024. Immunic, Inc., a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of its lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID­­_REVIVE)."

"There remains an urgent need for the treatment of Post COVID Syndrome (PCS) and its related symptoms, including physical function and fatigue," stated Prof. Dr. Maria J.G.T. Vehreschild, Head of the Department of Infectious Diseases at the University Hospital Frankfurt and Principal Investigator for the RAPID_REVIVE trial. "That said, vidofludimus calcium is an ideal candidate for our trial, due to its proven antiviral and anti-inflammatory effects, as well as its potential ability to prevent Epstein-Barr virus (EBV) reactivation and reduce fatigue. We look forward to further enrolling patients in this trial."

"We are honored to have vidofludimus calcium chosen for this investigator-sponsored trial, run by such highly regarded investigators at esteemed institutions in Germany," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We have seen convincing data supporting vidofludimus calcium's antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our phase 2 CALVID-1 trial. Importantly, third-party research has identified EBV reactivation as a potential cause for fatigue, one of the most dominating symptoms for both PCS and multiple sclerosis (MS) patients, negatively impacting their quality of life and ability to participate in social activities. We aim to confirm the ability of vidofludimus calcium to influence fatigue and EBV reactivation in our ongoing MS trials and look forward to receiving additional data from the RAPID_REVIVE trial. It is our belief that this may create yet another differentiating feature for this product candidate."

In patients with PCS, fatigue is by far the most prevalent symptom. Similarly, fatigue is frequently experienced by MS patients, often to such an extent that it interferes with quality of life. Recent third-party data in PCS patients have identified EBV reactivation as a leading risk factor and potential cause for fatigue in this patient group. Depending on the clinical study, EBV reactivation is observed in 55-95% of PCS patients. A recent study found detectable amounts of EBV DNA, a sign of lytic EBV reactivation, in throat washes of 50% of PCS patients experiencing fatigue compared to 20% of those without fatigue.

Vidofludimus calcium is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive MS, respectively. Preclinical experiments showed a dose-dependent reduction for vidofludimus calcium of lytic EBV reactivation in B cells as well as reduced lytic EBV production in Akata cells. A post-hoc analysis of Immunic's previous phase 2 CALVID-1 trial in COVID-19 patients revealed a lower prevalence of Post COVID fatigue using a patient questionnaire. Notably, 80% of patients who received placebo reported fatigue, compared to 50% who received 45 mg vidofludimus calcium. Fatigue decreased in both treatment groups over the next 9-17 weeks to 33% for placebo and to 17% for vidofludimus calcium. Given the known suppression of EBV reactivation observed for vidofludimus calcium in in vitro experiments, lowering patient's assessment of fatigue as observed in PCS patients may, potentially, also extend to MS patients. Signs of EBV reactivation and prevalence of patient-reported fatigue are also being investigated in the ongoing clinical trials of Immunic in relapsing and progressive MS patients.

Study Details

The phase 2 RAPID_REVIVE trial (EudraCT number: 2024-511628-16-00) is a randomized, placebo-controlled, double-blind, parallel group trial led by Prof. Dr. Vehreschild and sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research (BMBF).

The trial, for which Immunic is providing study medication, plans to enroll 376 patients at 11 clinical sites in Germany. Following a 7-day screening period during the initialization phase, patients will be randomized 1:1 to receive either vidofludimus calcium (22.5 mg initiation dose for 7 days, followed by 45 mg for 49 days) or placebo. Thereafter, a response-adaptive randomization procedure will be followed. The trial will also include a 28-day follow-up period. The primary endpoint of the trial is the intra-patient change in physical function as measured by the Short Form-36 Physical Function (SF-36-PF) from baseline to day 56. Secondary endpoints include mental and physical health, intensity of fatigue and incapacitation, severity of mental disorder symptoms, and cognitive function.

About Vidofludimus Calcium (IMU-838)Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals 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 biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). 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, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking StatementsThis 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, government grants to fund clinical trials, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such 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 as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed 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 earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, 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 statement made in this release speaks only as of the date of this release. Immunic disclaims any intent 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 all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Posted : 2024-09-06 08:51

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