– New Data Suggests that IMU-856 Could Be a
Potential Oral Treatment Option for Weight Management; Program Is
Phase 2 Ready –
– Dose-Dependent Increase of Endogenous GLP-1
Levels Observed in Post Hoc Analysis of Patients From Phase
1b Clinical Trial in Celiac Disease
–
– Dose-Dependent Reduction of Body Weight
Gain and Food Consumption Observed in Preclinical Study –
– Webcast to be Held Today, February 20 at 8:00 am
ET –
NEW
YORK, Feb. 20, 2025 /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 that IMU-856, an orally available and
systemically acting small molecule modulator that targets SIRT6
(Sirtuin 6), demonstrated a dose-dependent increase of endogenous
glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of
patients from its phase 1b clinical
trial in celiac disease. IMU-856 also showed a dose-dependent
reduction of body weight gain and food consumption in
preclinical in vivo testing. These effects may indicate the
potential for IMU-856 as an oral treatment option for weight
management.
"GLP-1, a hormone that occurs naturally in the gut, is released
after eating and helps the body regulate blood sugar and satiety.
It plays several critical roles, including triggering insulin
release from the pancreas and blocking glucagon, a hormone raising
blood sugar. Additionally, GLP-1 affects areas of the brain that
process hunger and satiety," noted Hella
Kohlhof, Ph.D., Chief Scientific Officer of Immunic.
"IMU-856's target, SIRT6, is highly expressed in cells of the bowel
wall, including enteroendocrine cells, which produce
gastrointestinal hormones such as GLP-1 and gastric inhibitory
peptide (GIP). Our phase 1b clinical
trial in celiac disease patients demonstrated IMU-856's ability to
regenerate epithelial cells, as measured by protection of villous
height and improved cellular function. The current observations of
increased GLP-1 in these celiac disease patients and the
preclinical signs of reduced body weight gain indicate that IMU-856
may also have the effect of activating the function of
enteroendocrine cells. These findings corroborate the tissue
renewal effects already seen for IMU-856 and warrant continued
evaluation, as they may meaningfully expand the potential
indications for IMU-856."
New data is available from a post hoc analysis of the company's
phase 1b clinical trial of IMU-856 in
celiac disease patients, where blood concentrations of GLP-1 were
measured, between baseline and day 28, in a fasting state. A highly
statistically significant (day 29: 80 mg p=0.014; 160 mg p=0.003)
and dose-dependent increase of GLP-1 versus placebo control was
detectable, even in the small patient population in this phase
1b clinical trial (baseline: N
placebo = 11, N 80 mg IMU-856 = 13, N 160 mg IMU-856 = 13). These
clinical findings were corroborated by effects observed in a
6-month preclinical in vivo study, where IMU-856 was found
to reduce body weight gain accompanied by food consumption in a
dose-dependent fashion up to -40 %, compared to the control group,
which was found to be linked to reduced food intake.
"This newly released clinical and preclinical data demonstrating
IMU-856's potential positive effect on GLP-1 and food consumption
is an exciting development for Immunic's oral small molecule
program," stated Daniel Vitt, Ph.D.,
Chief Executive Officer of Immunic. "Data from our phase
1b clinical trial in celiac disease
patients showed, under fasting conditions, a dose-dependent
increase of naturally occurring GLP-1 levels of up to 250 % versus
placebo. This compares favorably to the typical physiological 2-3
times increase in GLP-1 in healthy humans after a meal, indicating
that IMU-856 may replicate the natural effect after eating. While
currently available incretin mimetics delivered via subcutaneous
injection are focused on one or two enteroendocrine hormones, we
hypothesize that the SIRT6 modulation approach may result in a
broader, more physiologic activation of enteroendocrine hormones,
which we plan to explore further. If the effects reported today can
be confirmed in further clinical trials, our convenient, once-daily
small molecule tablet may represent an oral treatment option for
obesity – a market with millions of people affected worldwide and
which is expected to reach more than $170
billion globally by 2031. Our IMU-856 program offers the
potential for immediate phase 1b or
phase 2 clinical testing. As such, we will continue to analyze the
findings and assess any next steps."
Webcast and Presentation Information
Immunic will host
a webcast today at 8:00 am ET. To
participate in the webcast, please register in advance at:
https://imux.zoom.us/webinar/register/WN_o9yQAoqtT3yWnjb0049_Dw or
on the "Events and Presentations" section of Immunic's website at
ir.imux.com/events-and-presentations. Registrants will receive a
confirmation email containing a link for online participation or a
telephone number for dial in access.
An archived replay of the webcast will be available
approximately one hour after completion on Immunic's website at
ir.imux.com/events-and-presentations.
Today's update, along with phase 1b biomarker data for IMU-856, will also be
presented as a digital oral presentation at the 19th Congress of
ECCO (European Crohn's and Colitis Organisation). The presentation
will be accessible on the "Events and Presentations" section of
Immunic's website at:
https://ir.imux.com/events-and-presentations.
- Presentation Title: Promising Effects of IMU-856, an
Orally Available Epigenetic Modulator of Barrier Regeneration -
Biomarker Findings from a Phase 1 Clinical Study
- Presenting Author: Amelie
Schreieck, Ph.D., Senior Manager Biomarker Development,
Immunic
- Abstract Number: EC25-1515
- Presentation Number: DOP012
- Presentation Time: 5:57 pm
– 6:03 pm CET
- Session Name: Digital Oral Presentation (DOP) Session 2:
Clinical Trials II
- Session Date: February 20,
2025
- Session Hall: A8
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 and other
intestinal barrier function associated diseases. Based on
preclinical investigations demonstrating no suppression of immune
cells, IMU-856 may have the potential to maintain immune
surveillance for patients during therapy, which would be 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. In a post hoc
analysis of patients from the phase 1b clinical trial, IMU-856 demonstrated a
dose-dependent increase of endogenous glucagon-like peptide-1
(GLP-1) levels and, in preclinical testing, showed a dose-dependent
reduction of body weight gain and food consumption, indicating
potential as a possible oral treatment option for weight
management. The company is currently preparing for further clinical
testing. 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, 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 as well as
inflammatory bowel disease, Graft-versus-Host-Disease and weight
management. 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 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
IMU-856 to safely and effectively target diseases or to reduce body
weight gain and food consumption; other preclinical and clinical
data for IMU-856; 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, including the
ability to satisfy the minimum average price and trading volume
conditions required to receive funding in tranche 2 and 3 of the
January 2024 private placement, the
fact that the results of earlier preclinical studies and clinical
trials may not be predictive of future clinical trial results, any
changes to the size of the target markets for the Company's
products or product candidates, 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 of 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@kcsa.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/immunics-oral-imu-856-demonstrated-dose-dependent-increase-of-glp-1-in-celiac-disease-patients-and-corresponding-effects-in-preclinical-testing-302381158.html
SOURCE Immunic, Inc.