– Fundamental New Patent Covers Treatment of
Multiple Sclerosis Into 2038 and Beyond –
– Third U.S. Patent Directed to Use of
Vidofludimus Calcium in Multiple Sclerosis –
– Multilayered Intellectual Property Strategy
Provides Protection Into 2041 in the U.S. and Into 2038
Internationally, Unless Extended Further –
– Adds on Recently Allowed U.S. Patent
Protecting Specific Dose Strength for Relapsing Multiple Sclerosis
Treatment –
NEW
YORK, Nov. 21, 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 17/992,162, entitled, "Compounds and
Dosage Regimen for Use in the Prevention or Treatment of Chronic
Inflammatory and/or Autoimmune Diseases."
Specifically, the resulting patent covers dosing regimens
associated with lead asset, vidofludimus calcium (IMU-838), and
other salt forms as well as free acid forms for the treatment of
multiple sclerosis (MS), including all regimens tested in the
company's MS clinical program. The patent is expected to provide
protection into 2038, and, if additional Patent Term Extension is
granted, may offer up to 14 years of market exclusivity in
the United States upon the drug's
potential approval. The patent was previously granted to the
company in Japan and certain other
countries. This patent adds on the recently received notice of
allowance for patent application 17/391,442, claiming treatment of
relapsing MS (RMS) with specific dose strengths.
"Coming on the heels of the recently granted dose strength
patent for vidofludimus and its salts for the treatment of RMS,
granting of this next fundamental patent in the United States, Japan and other countries is a critical
achievement and helps to significantly strengthen the multiple
layers of protection we have built around vidofludimus calcium,"
stated Daniel Vitt, Ph.D., Chief
Executive Officer and President of Immunic. "This patent for dosing
regimens in MS patients covers all salt and free acid forms of
vidofludimus and links the expected label with respective patent
claims. Going forward, we expect to continue to expand the layers
of patent protection around vidofludimus calcium, in order to
extend the exclusivity period upon its potential regulatory
approval."
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;
the treatment of RMS with a specific dose strength used in the
clinical trials; as well as the dosing regimens, including those
used in clinical trials for the treatment of MS, 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; as well as the use of vidofludimus calcium and
other salt forms as well as free acid forms for treating
neurodegenerative diseases. If granted, these applications could
provide protection up to 2044, unless extended further. Finally,
further 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, 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, 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 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,
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.