NEW
YORK, Feb. 29, 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 the presentation of data from
the company's phase 2 CALLIPER and CALVID-1 clinical trials of lead
asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus
calcium (IMU-838), in two poster presentations at the Americas
Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2024, taking place from February 29 to March 2, in West Palm Beach, FL.
"Having two poster presentations on our lead asset, vidofludimus
calcium, at the prestigious ACTRIMS Forum is a testament to the
strength of the data we have generated," stated Daniel Vitt, Ph.D., Chief Executive Officer and
President of Immunic. "In the interim analysis of our phase 2
CALLIPER trial, we saw a clear separation of vidofludimus calcium
from placebo in serum neurofilament light chain (NfL) levels across
all progressive multiple sclerosis (PMS) patients as well as all
subtypes. We believe that the data set provides biomarker evidence
that vidofludimus calcium's activity extends beyond the previously
observed anti-inflammatory effects, further reinforcing its
neuroprotective potential. The next inflection point for this
potentially first-in-class Nurr1 activator for the treatment of PMS
is the CALLIPER top-line data, expected in April of next year."
Dr. Vitt continued, "Our second poster on the phase 2 CALVID-1
trial illustrates that, because of vidofludimus calcium's potential
ability to prevent the reactivation of the Epstein-Barr virus
(EBV), it may also contribute to the reduction of fatigue in MS
patients. While fatigue is one of the most dominating symptoms for
MS patients influencing their quality of life and ability to
participate in social activities, it remains largely unsolved from
the clinical perspective. Our clinical trial in COVID-19 patients
showed an initial signal that patients treated with vidofludimus
calcium showed the post COVID symptom of fatigue less frequent than
patients in the placebo arm. Recent third-party data in post COVID
patients identified EBV reactivation as a potential cause for
fatigue in this patient group. We aim to confirm the ability of
vidofludimus calcium to influence fatigue and EBV reactivation in
our ongoing phase 3 ENSURE trials in relapsing MS patients and hope
that this may create yet another differentiating feature for this
medication candidate."
Presentation Details:
- Poster Title: Impact of Vidofludimus Calcium on Serum
Neurofilament in Progressive MS: Data from the CALLIPER Interim
Analysis
- Presenting Author: Robert
J. Fox, MD, Staff Neurologist, Mellen Center for Multiple
Sclerosis, Vice-Chair for Research, Neurological Institute,
Cleveland Clinic, Cleveland,
Ohio
- Abstract Number: 509
- Poster Number: P044
- Poster Session: 1
- Date: Thursday, February 29,
2024
- Time: 6:00 – 7:30 pm
ET
CALLIPER is a multicenter, randomized, double-blind,
placebo-controlled phase 2 trial assessing efficacy and safety of
vidofludimus calcium in PMS. The trial enrolled 467 patients with
primary PMS (35.2%), non-active secondary PMS (59.5%), and active
secondary PMS (7.9%) who were randomized 1:1 to vidofludimus
calcium or placebo. A pre-planned interim analysis was conducted
after half of the study participants completed 24 weeks of study
treatment and had biomarker data available at baseline and Week 24.
In total, 203 patients were included in the interim analysis, of
which 29% had primary PMS, 61% non-active secondary PMS, and 10%
active secondary PMS. Compared to placebo, serum NfL was decreased
in the treatment group by 22.4% (p=0.01, post hoc). Additionally, a
reduction was seen across all subtypes: -18.8% in primary PMS,
-20.1% in non-active secondary PMS and -43.3% in active secondary
PMS.
- Poster Title: May Vidofludimus Calcium
Potentially be Used to Reduce Fatigue in Multiple Sclerosis by
Blocking EBV Reactivation?
- Presenting Author: Dr. Alexandra Herrmann, Manager Translational
Pharmacology, Immunic
- Abstract Number: 6
- Poster Number: P271
- Poster Session: 2
- Date: Friday, March 1,
2024
- Time: 6:00 – 7:30 pm
ET
In the phase 2 CALVID-1 trial, patients aged 18 years or older
who tested positive for COVID-19 were randomized to receive placebo
or 45 mg of vidofludimus calcium for 14 days, with both groups
receiving standard-of-care treatment. An analysis of the antiviral
activity of vidofludimus calcium revealed a dose-dependent
reduction of lytic EBV reactivation in B cells as well as reduced
lytic EBV production in Akata cells. Results from a post hoc
analysis of post COVID syndrome (PCS) symptoms indicated a
potential contribution of vidofludimus calcium to the prevention of
long-term fatigue, which is one of the most common PCS symptoms and
known to be related to EBV reactivation. 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. Therefore, by preventing the reactivation of
EBV, vidofludimus calcium may also contribute to the reduction of
fatigue in multiple sclerosis patients.
The poster presentations will be accessible on the "Events and
Presentations" section of Immunic's website at:
https://ir.imux.com/events-and-presentations.
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, sufficiency of cash, 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
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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SOURCE Immunic, Inc.