MediciNova Receives a Notice of Allowance for a New Patent Covering the Combination of MN-166 (ibudilast) and Riluzole for the Treatment of Amyotrophic Lateral Sclerosis (ALS) in Canada
2023年10月11日 - 8:00AM
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ
Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo
Stock Exchange (Code Number: 4875), today announced that it has
received a Notice of Allowance from the Canadian Intellectual
Property Office for a pending patent application which
covers the combination of MN-166 (ibudilast) and riluzole for the
treatment of amyotrophic lateral sclerosis (ALS).
Once issued, the patent maturing from this
allowed patent application is expected to expire no earlier
than November 2035. The allowed claims cover the use of the
combination of MN-166 (ibudilast) and riluzole for treating a
patient diagnosed with ALS when administered in a tablet, a
capsule, or a liquid dosage form. The allowed claims
specifically cover the use of the combination of MN-166 (ibudilast)
and riluzole for slowing progression of disease in a patient
diagnosed with ALS when administered in a tablet, a capsule, or a
liquid dosage form. The allowed claims cover a wide range of doses
and a range of dosing regimens for both MN-166 (ibudilast) and
riluzole.
Kazuko Matsuda, MD, PhD, MPH, Chief Medical
Officer of MediciNova, Inc., commented, "We are very pleased
to receive notice that this new patent will be granted. Previously,
similar patents were granted in the U.S., Japan, and
Europe based on data from our first clinical trial in ALS
patients. We previously announced results of a responder analysis
which found that the proportion of responders, defined as stable or
improved in the ALS functional score, muscle test and subjective
ALSAQ-5 quality of life assessment, was higher in the MN-166 plus
riluzole-treated group compared to the riluzole-only group. We
believe this new patent could substantially increase the potential
value of MN-166. We are currently conducting a Phase 3
clinical trial with ALS patients in
the U.S. and Canada. The U.S. FDA
granted both orphan-drug designation and fast-track designation to
MN-166 for the treatment of ALS, and the European
Commission granted Orphan Medicinal Product Designation to
MN-166 for the treatment of ALS."
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule compound
that inhibits phosphodiesterase type-4 (PDE4) and inflammatory
cytokines, including macrophage migration inhibitory factor (MIF).
It is in late-stage clinical development for the treatment of
neurodegenerative diseases such as ALS (amyotrophic lateral
sclerosis), progressive MS (multiple sclerosis), and DCM
(degenerative cervical myelopathy); and is also in development for
glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral
neuropathy), and substance use disorder. In addition, MN-166
(ibudilast) was evaluated in patients that are at risk for
developing acute respiratory distress syndrome (ARDS).
About MediciNova
MediciNova, Inc. is a clinical-stage
biopharmaceutical company developing a broad late-stage pipeline of
novel small molecule therapies for inflammatory, fibrotic, and
neurodegenerative diseases. Based on two compounds, MN-166
(ibudilast) and MN-001 (tipelukast), with multiple mechanisms of
action and strong safety profiles, MediciNova has 11 programs in
clinical development. MediciNova’s lead asset, MN-166 (ibudilast),
is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and
degenerative cervical myelopathy (DCM) and is Phase 3-ready for
progressive multiple sclerosis (MS). MN-166 (ibudilast) is also
being evaluated in Phase 2 trials in glioblastoma, Long COVID, and
substance dependence. MN-001 (tipelukast) was evaluated in a Phase
2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2
trial in non-alcoholic fatty liver disease (NAFLD) is ongoing.
MediciNova has a strong track record of securing
investigator-sponsored clinical trials funded through government
grants.
Statements in this press release that are not
historical in nature constitute forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include, without limitation, statements regarding the future
development and efficacy of MN-166, MN-001, MN-221, and MN-029.
These forward-looking statements may be preceded by, followed by,
or otherwise include the words "believes," "expects,"
"anticipates," "intends," "estimates," "projects," "can," "could,"
"may," "will," "would," “considering,” “planning” or similar
expressions. These forward-looking statements involve a number of
risks and uncertainties that may cause actual results or events to
differ materially from those expressed or implied by such
forward-looking statements. Factors that may cause actual results
or events to differ materially from those expressed or implied by
these forward-looking statements include, but are not limited to,
risks of obtaining future partner or grant funding for development
of MN-166, MN-001, MN-221, and MN-029 and risks of raising
sufficient capital when needed to fund MediciNova's operations and
contribution to clinical development, risks and uncertainties
inherent in clinical trials, including the potential cost, expected
timing and risks associated with clinical trials designed to meet
FDA guidance and the viability of further development considering
these factors, product development and commercialization risks, the
uncertainty of whether the results of clinical trials will be
predictive of results in later stages of product development, the
risk of delays or failure to obtain or maintain regulatory
approval, risks associated with the reliance on third parties to
sponsor and fund clinical trials, risks regarding intellectual
property rights in product candidates and the ability to defend and
enforce such intellectual property rights, the risk of failure of
the third parties upon whom MediciNova relies to conduct its
clinical trials and manufacture its product candidates to perform
as expected, the risk of increased cost and delays due to delays in
the commencement, enrollment, completion or analysis of clinical
trials or significant issues regarding the adequacy of clinical
trial designs or the execution of clinical trials, and the timing
of expected filings with the regulatory authorities, MediciNova's
collaborations with third parties, the availability of funds to
complete product development plans and MediciNova's ability to
obtain third party funding for programs and raise sufficient
capital when needed, and the other risks and uncertainties
described in MediciNova's filings with the Securities and Exchange
Commission, including its annual report on Form 10-K for the year
ended December 31, 2022 and its subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Undue reliance should not be
placed on these forward-looking statements, which speak only as of
the date hereof. MediciNova disclaims any intent or obligation to
revise or update these forward-looking statements.
INVESTOR CONTACT:
Geoff O'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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