– Patent Will Also Cover a Related Method of
Production of the Material –
– Fourth U.S. Patent Directed to Use of
Vidofludimus Calcium in Multiple Sclerosis –
– Multilayered Intellectual Property Strategy
Provides Protection Into 2041 in the
United States and Into 2039 Internationally, Unless Extended
Further –
NEW
YORK, March 20, 2024
/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 16/981,122, entitled,
"Calcium salt polymorphs as anti-inflammatory, immunomodulatory and
anti-proliferative agents," covering the composition-of-matter of a
specific polymorph of vidofludimus calcium (IMU-838) and a related
method of production of the material. The claims are expected to
provide protection into 2039, unless extended further. The patent
was previously granted to the company in Australia, Canada, Indonesia, Japan and Mexico.
"Allowance of this key composition-of-matter
patent, covering the specific polymorph of vidofludimus calcium,
provides another important layer of proprietary intellectual
property protection around our lead, late-stage asset," stated
Daniel Vitt, Ph.D., Chief Executive
Officer and President of Immunic. "A significant part of this
patent will also cover the related method of producing material of
vidofludimus calcium used in our studies. Importantly, we meanwhile
have eight patent families active for vidofludimus. Our commitment
to protecting the technology behind this phase 3 asset remains
paramount and is made that much stronger by the addition of this
fourth U.S. patent directed to the use of vidofludimus calcium in
multiple sclerosis."
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, including the
specific calcium salt form used in Immunic's clinical trials; the
treatment of relapsing multiple sclerosis with a specific dose
strength used in the clinical trials; the dosing regimens,
including those used in clinical trials for the treatment of
multiple sclerosis; as well as composition-of-matter of a specific
polymorph of vidofludimus calcium and a related method of
production of the material, as reported in this announcement. In
the United States, these patents
provide protection into 2041, unless extended further. In addition,
a pending application is directed towards the use of vidofludimus
calcium and other salt forms as well as free acid forms for
treating neurodegenerative diseases. If granted, this application
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 1,800 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, for
which 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,
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 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
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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SOURCE Immunic, Inc.