NEW
YORK, Oct. 15, 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 1b clinical trial
of IMU-856, an orally available and systemically acting small
molecule modulator that targets SIRT6 (Sirtuin 6), in patients with
celiac disease in a moderated poster session at the United European
Gastroenterology Week (UEGW) 2023, taking place October 14-17 in Copenhagen.
In this phase 1b, double-blind,
randomized, placebo-controlled trial in patients with celiac
disease, IMU‑856 showed positive effects over placebo in four key
dimensions of clinical outcome: protection of the gut architecture,
improvement of patients' symptoms, biomarker response and
enhancement of nutrient absorption. IMU-856 was also found to be
safe and well-tolerated with a benign adverse event profile and
with pharmacokinetics that allow once-daily dosing. There were no
systematic clinically relevant findings relative to safety and
tolerability, as assessed by physical examination, clinical
laboratory tests, vital signs, and 12-lead electrocardiograms.
"We were delighted to hear that, according to the UEGW, our
IMU-856 poster was selected as one of the best among the abstracts
submitted," stated Daniel Vitt,
Ph.D., Chief Executive Officer and President of Immunic. "In our
phase 1b clinical trial, IMU-856
showed the first clinical signals of its potential ability to
restore a healthy gut by renewal of the gut wall in patients with
celiac disease. These stronger than expected results across
histology, disease symptoms, biomarkers and nutrient absorption,
along with the drug's clean safety and tolerability profile, may
set the stage for a potential first-in-class, oral celiac disease
therapy. IMU-856 may also offer extensive potential beyond celiac
disease in other gastrointestinal diseases with high unmet needs
such as ulcerative colitis, Crohn's disease, or irritable bowel
syndrome with diarrhea."
Poster Details:
- Title: First in Human Trial of IMU-856, An Orally
Available Epigenetic Modulator of Barrier Regeneration for the
Treatment of Celiac Disease
- Abstract Number: AS-UEG-2023-01180
- Poster Number: MP147
- Presenting Author: Franziska
Burianek, M.D., Senior Medical Director, Immunic
- Poster Session: Coeliac disease
- Location: Moderated Posters, Poster Stage 3
- Date: Sunday, October 15,
2023
- Time: 5:48 – 5:54 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 IMU-856
IMU-856 is an orally available and systemically acting small
molecule modulator that targets SIRT6 (Sirtuin 6), a protein which
serves as a transcriptional regulator of intestinal barrier
function and regeneration of bowel epithelium. Based on preclinical
data, the compound may represent a unique treatment approach, as
the mechanism of action targets the restoration of the intestinal
barrier function and bowel wall architecture in patients suffering
from gastrointestinal diseases such as celiac disease, inflammatory
bowel disease, irritable bowel syndrome with diarrhea and other
intestinal barrier function associated diseases. Immunic believes
that, because IMU-856 has been shown in preclinical investigations
to avoid suppression of immune cells, it may therefore have the
potential to maintain immune surveillance for patients during
therapy, an important advantage versus immunosuppressive
medications. IMU-856 demonstrated positive results in a phase
1b clinical trial in celiac disease
patients in four key dimensions of the disease's pathophysiology:
histology, disease symptoms, biomarkers and nutrient absorption.
Currently, the company is preparing for phase 2 clinical testing in
this patient population. IMU-856 is an investigational drug product
that has not been approved in any jurisdiction.
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.