STOCK TITAN

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

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags
clinical trial covid-19

Immunic, Inc. (Nasdaq: IMUX) announced the enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of vidofludimus calcium (IMU-838) for Post COVID Syndrome (PCS). The trial, named RAPID_REVIVE, is sponsored by Goethe University Frankfurt and funded by a German government grant. The study aims to assess vidofludimus calcium's effectiveness in treating PCS symptoms, particularly fatigue, and its ability to suppress Epstein-Barr virus (EBV) reactivation.

The trial will enroll 376 patients across 11 German sites, with a primary endpoint of change in physical function measured by SF-36-PF. Vidofludimus calcium has shown promise in preclinical and clinical studies for its antiviral and anti-inflammatory effects, as well as potential to reduce fatigue in PCS and multiple sclerosis (MS) patients.

Immunic, Inc. (Nasdaq: IMUX) ha annunciato l'arruolamento del primo paziente in uno studio clinico di fase 2 sponsorizzato da un investigatore per il vidofludimus calcio (IMU-838) per la Sindrome Post COVID (PCS). Lo studio, chiamato RAPID_REVIVE, è sponsorizzato dall'Università Goethe di Francoforte ed è finanziato da un contributo del governo tedesco. L'obiettivo dello studio è valutare l'efficacia del vidofludimus calcio nel trattare i sintomi della PCS, in particolare la fatica, e la sua capacità di sopprimere la riattivazione del virus di Epstein-Barr (EBV).

Lo studio arruolerà 376 pazienti in 11 centri in Germania, con un obiettivo primario di cambiamento nella funzione fisica misurato tramite SF-36-PF. Il vidofludimus calcio ha mostrato promettenti risultati negli studi preclinici e clinici per i suoi effetti antivirali e antinfiammatori, così come per il potenziale di riduzione della fatica nei pazienti con PCS e sclerosi multipla (SM).

Immunic, Inc. (Nasdaq: IMUX) anunció el reclutamiento del primer paciente en un ensayo clínico de fase 2 patrocinado por un investigador para el vidofludimús calcio (IMU-838) para el Síndrome Post COVID (PCS). El ensayo, denominado RAPID_REVIVE, es patrocinado por la Universidad Goethe de Francfort y financiado por una subvención del gobierno alemán. El estudio tiene como objetivo evaluar la eficacia del vidofludimús calcio en el tratamiento de los síntomas del PCS, en particular la fatiga, y su capacidad para suprimir la reactivación del virus de Epstein-Barr (EBV).

El ensayo incluirá a 376 pacientes en 11 sitios en Alemania, con un objetivo primario de cambio en la función física medido a través del SF-36-PF. El vidofludimús calcio ha demostrado ser prometedor en estudios preclínicos y clínicos por sus efectos antivirales y antiinflamatorios, así como su potencial para reducir la fatiga en pacientes con PCS y esclerosis múltiple (EM).

Immunic, Inc. (나스닥: IMUX)는 vidofludimus calcium (IMU-838)에 대한 임상 연구자 주도의 2상 임상 시험에 첫 번째 환자가 등록되었다고 발표했습니다. 이 시험은 RAPID_REVIVE라는 이름으로 고에 대학에서 후원하고 독일 정부 보조금으로 자금을 지원받고 있습니다. 이 연구는 vidofludimus calcium이 COVID 후 증후군(PCS)의 증상, 특히 피로를 치료하는 데 효과적인지 평가하려는 목표를 가지고 있으며, Epstein-Barr 바이러스(EBV) 재활성화를 억제하는 능력도 조사합니다.

이 시험은 독일의 11개 사이트에서 376명의 환자를 등록하며, 주요 목표는 SF-36-PF를 통해 측정된 신체적 기능의 변화를 포함합니다. vidofludimus calcium은 전임상 및 임상 연구에서 항바이러스 및 항염증 작용으로 유망한 결과를 보여주었으며, PCS 및 다발성 경화증(MS) 환자들에서 피로를 줄일 수 있는 잠재력도 보여주었습니다.

Immunic, Inc. (Nasdaq: IMUX) a annoncé l'inscription du premier patient dans un essai clinique de phase 2 sponsorisé par un enquêteur sur le vidofludimus calcium (IMU-838) pour le Syndrome Post COVID (PCS). L'essai, nommé RAPID_REVIVE, est sponsorisé par l'Université Goethe de Francfort et financé par une subvention du gouvernement allemand. L'étude vise à évaluer l'efficacité du vidofludimus calcium dans le traitement des symptômes du PCS, en particulier la fatigue, ainsi que sa capacité à supprimer la réactivation du virus d'Epstein-Barr (EBV).

L'essai impliquera 376 patients répartis sur 11 sites en Allemagne, avec un objectif principal mesurant le changement de la fonction physique à l'aide du SF-36-PF. Le vidofludimus calcium a montré des résultats prometteurs dans les études précliniques et cliniques pour ses effets antiviraux et anti-inflammatoires, ainsi que son potentiel à réduire la fatigue chez les patients atteints de PCS et de sclérose en plaques (SEP).

Immunic, Inc. (Nasdaq: IMUX) gab bekannt, dass der erste Patient in eine Phase 2-Studie für vidofludimus Calcium (IMU-838) bei Post-COVID-Syndrom (PCS) eingeschrieben wurde, die von einem Untersucher geleitet wird. Die Studie mit dem Namen RAPID_REVIVE wird von der Goethe-Universität Frankfurt gesponsert und durch einen deutschen Staatszuschuss finanziert. Ziel der Studie ist es, die Wirksamkeit von vidofludimus Calcium bei der Behandlung von PCS-Symptomen, insbesondere von Müdigkeit, zu bewerten und die Fähigkeit zur Unterdrückung der Reaktivierung des Epstein-Barr-Virus (EBV) zu untersuchen.

Das Studienprotokoll sieht vor, 376 Patienten an 11 Standorten in Deutschland einzuschreiben, mit einem primären Endpunkt, der eine Veränderung der körperlichen Funktion misst, die durch SF-36-PF evaluiert wird. vidofludimus Calcium hat in präklinischen und klinischen Studien vielversprechende Ergebnisse hinsichtlich seiner antiviralen und entzündungshemmenden Wirkungen gezeigt, ebenso wie Potenzial zur Reduzierung von Müdigkeit bei Patienten mit PCS und Multipler Sklerose (MS).

Positive
  • First patient enrolled in phase 2 trial for Post COVID Syndrome treatment
  • Trial funded by German government grant, reducing company expenses
  • Potential to address fatigue in both PCS and MS patients
  • Previous phase 2 CALVID-1 trial showed reduced fatigue in COVID-19 patients treated with vidofludimus calcium
Negative
  • Results from the trial are not yet available
  • Efficacy in treating PCS and suppressing EBV reactivation is still unproven

Insights

The initiation of this phase 2 trial for vidofludimus calcium in Post COVID Syndrome (PCS) is a significant development. The study's focus on fatigue and Epstein-Barr virus (EBV) reactivation could have far-reaching implications beyond PCS. Key points:

  • The trial's design to assess physical function, fatigue and EBV reactivation aligns with recent research linking EBV to PCS fatigue.
  • Previous data showing vidofludimus calcium's ability to reduce EBV reactivation and fatigue in COVID-19 patients is promising.
  • The potential application to Multiple Sclerosis (MS), where fatigue is also a major symptom, expands the drug's market potential.

While promising, investors should note that this is an early-stage trial and results are not guaranteed. The involvement of respected institutions and government funding adds credibility but doesn't ensure success.

This news presents a positive development for Immunic, potentially expanding the application of its lead asset. Key financial implications:

  • The government-funded, investigator-sponsored trial reduces Immunic's financial burden while advancing research.
  • Positive results could significantly increase the market potential of vidofludimus calcium beyond MS, into PCS and potentially other fatigue-related conditions.
  • The dual focus on PCS and MS could enhance the drug's value proposition, potentially leading to increased investor interest.

However, it's important to remember that this is an early-stage trial and the financial impact remains speculative. Investors should monitor the trial's progress and upcoming MS trial results for a more comprehensive assessment of the drug's potential.

– Investigator Study Sponsored by Goethe University Frankfurt (Germany), Funded via a German Government Grant; Study Drug Vidofludimus Calcium Provided by Immunic

In Addition to Post COVID Readouts, Study Designed to Deliver Important Data on the Activity of Vidofludimus Calcium Suppressing Epstein-Barr Virus Reactivation and Related Fatigue Symptoms; Third-Party Research Identified Epstein-Barr Virus Reactivation as Potential Cause for Post COVID Fatigue –

– Severe Fatigue Also a Common and Debilitating Symptom for Multiple Sclerosis Patients
with No Effective Therapies Available; Potential Read-Through to Immunic's Multiple Sclerosis Development Program –

NEW YORK, Sept. 4, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), 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 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, 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 UkraineRussia 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.

Contact Information

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact 
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@ksca.com

Immunic, Inc. Logo (PRNewsfoto/Immunic, Inc.)

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/immunic-announces-first-patient-enrolled-in-investigator-sponsored-phase-2-clinical-trial-of-vidofludimus-calcium-in-patients-with-post-covid-syndrome-302237781.html

SOURCE Immunic, Inc.

FAQ

What is the purpose of the RAPID_REVIVE trial for IMUX's vidofludimus calcium?

The RAPID_REVIVE trial aims to assess the effectiveness of vidofludimus calcium in treating Post COVID Syndrome symptoms, particularly fatigue, and its ability to suppress Epstein-Barr virus reactivation in patients.

How many patients will be enrolled in the RAPID_REVIVE trial for IMUX's drug?

The trial plans to enroll 376 patients across 11 clinical sites in Germany.

What is the primary endpoint of the RAPID_REVIVE trial for IMUX's vidofludimus calcium?

The primary endpoint 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.

How does IMUX's vidofludimus calcium potentially address fatigue in Post COVID Syndrome?

Vidofludimus calcium has shown antiviral and anti-inflammatory effects in preclinical and clinical studies, and may suppress Epstein-Barr virus reactivation, which is linked to fatigue in Post COVID Syndrome patients.

Immunic, Inc.

NASDAQ:IMUX

IMUX Rankings

IMUX Latest News

IMUX Stock Data

109.90M
89.15M
3.44%
65.02%
4.21%
Biotechnology
Pharmaceutical Preparations
Link
United States of America
NEW YORK