Immunic Launches Phase 2 Trial of Vidofludimus Calcium for PCS
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Immunic Initiates Groundbreaking Phase 2 Trial
Immunic, Inc. (Nasdaq: IMUX) has taken a significant step in addressing the pressing health issue of Post COVID Syndrome (PCS) with the announcement of the first patient enrolled in its investigator-sponsored Phase 2 clinical trial. This initiative is being spearheaded by esteemed researchers at an academic institution, aiming to explore the impacts of Vidofludimus Calcium (IMU-838) on patients suffering from the long-term effects of COVID-19.
The Importance of This Clinical Trial
Post COVID Syndrome is characterized by a range of debilitating symptoms, the most common being severe fatigue. By enrolling patients in this trial, Immunic aims not only to address the symptoms of PCS but also to investigate the potential role of Epstein-Barr Virus reactivation in triggering these symptoms, particularly fatigue. Existing research has raised concerns about EBV reactivation as a contributing factor to fatigue among both PCS and multiple sclerosis (MS) patients.
Expert Insights
According to Prof. Dr. Maria J.G.T. Vehreschild, the Principal Investigator for the RAPID_REVIVE trial, there is a critical need for effective treatments for PCS and its associated fatigue. Prof. Vehreschild emphasized that Vidofludimus Calcium has shown promising antiviral and anti-inflammatory properties, positioning it as a strong candidate for this trial.
Corporate Overview
Daniel Vitt, Ph.D., CEO of Immunic, expressed pride in having Vidofludimus Calcium selected for this significant research initiative. The company is confident in the drug's potential to impact fatigue levels, based on previous studies indicating its effectiveness.
Trial Overview and Goals
The RAPID_REVIVE trial is a rigorous randomized, placebo-controlled, double-blind study designed to enroll 376 patients across multiple clinical sites. Immunic is providing the study medication, and the trial will focus on specific endpoints such as changes in physical function and mental health metrics over the course of the study.
About Vidofludimus Calcium
Vidofludimus Calcium is an innovative treatment currently advancing through multiple clinical trials, notably for treating relapsing and progressive MS. As a selective immune modulator, its action on the neuroprotective transcription factor Nurr1 is tied to direct neuroprotective properties and potential antiviral effects.
Future Directions
As the trial progresses, Immunic looks forward to gathering vital data that could also influence their ongoing multiple sclerosis research. The outcomes of this study may shed more light on the association between EBV reactivation and fatigue, with implications for treatment protocols in MS patients as well.
Contact Information
For more information, please reach out to Immunic, Inc. Contact:
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
[email protected]
Frequently Asked Questions
What is the purpose of the RAPID_REVIVE trial?
The trial aims to assess the effectiveness of Vidofludimus Calcium in treating Post COVID Syndrome, particularly its impact on fatigue and physical function.
Who is leading the clinical trial?
The trial is led by Prof. Dr. Maria J.G.T. Vehreschild from the University Hospital Frankfurt.
How many patients will be enrolled in the trial?
The study plans to enroll 376 patients at 11 clinical sites.
What is Vidofludimus Calcium?
Vidofludimus Calcium is an investigational medication targeted for chronic inflammatory and autoimmune diseases, including MS and PCS.
What are the expected outcomes of this trial?
The study will evaluate changes in physical and mental health, as well as fatigue levels in patients over a specified period.
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