NEW
YORK, Nov. 2, 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 that it has received a Notice of
Allowance from the United States Patent and Trademark Office
(USPTO) for patent application 17/391,442, entitled, "Treatment of
Multiple Sclerosis Comprising DHODH Inhibitors," covering a daily
dose of about 10 mg to 45 mg of vidofludimus calcium (IMU-838) and
other salt as well as free acid forms for the treatment of
relapsing multiple sclerosis (RMS). The claims are expected to
provide protection into 2041, unless extended further.
"Allowance of this patent, covering the dose strength of
vidofludimus calcium for the treatment of RMS, including the 30 mg
dosage used in our ongoing twin phase 3 ENSURE trials,
significantly bolsters the multilayered proprietary intellectual
property position we have strategically built around our lead,
late-stage program for patients with multiple sclerosis," stated
Daniel Vitt, Ph.D., Chief Executive
Officer and President of Immunic. "Importantly, this patent for the
dose strength in RMS patients covers all salt and free acid forms
of vidofludimus calcium. We remain committed to protecting the
technology around this phase 3 asset, in order to assure extended
exclusivity upon potential regulatory approval from the U.S. Food
and Drug Administration."
Vidofludimus calcium is covered by several layers of granted
patents in the United States,
Europe and other jurisdictions
around the world. These patents are directed towards
composition-of-matter for salt forms of vidofludimus calcium,
including the specific salt form used in Immunic's clinical trials,
as well as the dose strength used in clinical trials for the
treatment of RMS, as reported in this announcement. In the United States, these patents provide
protection into 2041, unless extended further. In addition, pending
applications are directed towards composition-of-matter of a
specific polymorph of vidofludimus calcium and a related method of
production of the clinical material; the dosing regimens including
those used in clinical trials for the treatment of MS; as well as
the use of vidofludimus calcium and other salt as well as free acid
forms for treating neurodegenerative diseases. If granted,
these applications could provide protection up to 2044, unless
extended further. Finally, additional undisclosed patent
applications dedicated to strengthening the exclusivity period are
currently in process. On top of the patent exclusivity,
vidofludimus calcium, as a new chemical entity, should also benefit
from regulatory data protection.
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.