– 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 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.
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
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SOURCE Immunic, Inc.