NEW
YORK, Oct. 16, 2023 /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 CALDOSE-1 trial of vidofludimus calcium
(IMU-838) in an oral presentation at the United European
Gastroenterology Week (UEGW) 2023, taking place October 14-17 in Copenhagen.
Geert R. D'Haens, M.D., Ph.D., Full Professor, AGEM - Amsterdam
Gastroenterology Endocrinology Metabolism and Gastroenterology and
Hepatology, Amsterdam University Medical Centers, The Netherlands, commented, "The maintenance
phase results of the phase 2b
CALDOSE-1 trial demonstrate statistically significant activity of
vidofludimus calcium compared to placebo and reaffirm the drug's
favorable safety and tolerability profile. The data, therefore,
validates the potential of vidofludimus calcium in UC and other
inflammatory bowel disease indications."
The CALDOSE-1 trial of vidofludimus calcium in
moderate-to-severe ulcerative colitis (UC) was a phase 2b, multicenter, randomized, double-blind,
placebo-controlled, dose-finding study, including a blinded 10-week
induction phase and a blinded 50-week maintenance phase. Data
presented today show that the induction phase did not achieve the
primary endpoint of clinical remission for the total population,
possibly because of interaction by corticosteroids started shortly
before randomization. In contrast, in the maintenance phase, at the
start of which concomitant corticosteroids were mandatorily
tapered, vidofludimus calcium showed a dose-linear increase in
clinical remission compared to placebo at week 50 (10 mg: 42.3%, 30
mg: 61.5%, placebo: 27.8%). Similarly, patients treated with
vidofludimus calcium achieved dose-linear increases in steroid-free
clinical remission, endoscopic healing and microscopic healing. An
exploratory statistical analysis showed superiority of the 30 mg
vidofludimus calcium treatment group over placebo for both clinical
remission (p=0.0358) and endoscopic healing (p=0.0259). Consistent
with prior data sets in other patient populations, administration
of vidofludimus calcium in this trial was found to be safe and
well-tolerated.
Presentation Details:
- Title: Efficacy and Safety of Vidofludimus Calcium
(IMU-838) In Patients With Moderately to Severely Active Ulcerative
Colitis (UC): Results From the Prospective Placebo-Controlled Phase
2 CALDOSE-1 Trial
- Abstract Number: AS-UEG-2023-01648
- Presenting Author: Dr. Geert R. D'Haens
- Presentation Session: The new kids on the block in IBD:
Part 2
- Location: Abstract Session, A3
- Date: Monday, October 16,
2023
- Time: 3:18 – 3:30 pm
CET
- The poster presentation is accessible on the "Events and
Presentations" section of Immunic's website at:
https://ir.imux.com/events-and-presentations.
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 1,400 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 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, where 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 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,
2022, filed with the SEC on February
23, 2023, 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
Head of 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.