MediciNova Receives a New Patent Covering MN-001 for the Treatment of Scleroderma and Systemic Sclerosis in Europe
15 Agosto 2023 - 6:00PM
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 it has received
a Decision to Grant from the European Patent Office for a
new patent which covers MN-001 (tipelukast) for the treatment of
scleroderma and/or systemic sclerosis.
This patent is expected to expire no earlier
than June 2035. The allowed claims cover the use of MN-001
(tipelukast) for inhibiting or treating scleroderma and/or systemic
sclerosis. The allowed claims cover oral administration, including
tablets and capsules, as well as liquid dosage forms. The allowed
claims cover a wide range of doses and a range of different dosing
frequencies.
Kazuko Matsuda, M.D. Ph.D., MPH., Chief Medical
Officer, MediciNova, Inc., commented, “This new patent is
based on positive results from a systemic sclerosis animal model
study conducted recently. The Canadian Intellectual Property
Office granted a similar patent earlier this year. We are very
pleased to receive notice of this new patent which covers Europe,
and we believe it could increase the potential value of
MN-001.”
About MN-001 (tipelukast)
MN-001 (tipelukast) is a novel, orally
administered, small molecule compound with multiple mechanisms of
action which has been in clinical development for the treatment of
chronic inflammatory and fibrotic diseases, among others, due to
its anti-inflammatory and anti-fibrosis effects. Based on the
finding that MN-001 (tipelukast) reduces triglycerides (TG) in the
blood from our previous clinical trials, we conducted a Phase 2
clinical trial in patients with hypertriglyceridemia and NASH or
NAFLD. Based on the findings from the in-vitro mechanistic study of
MN-001 (tipelukast), a subgroup analysis of the Phase 2 clinical
trial showed a stronger improvement in lipid profile in the
NASH/NAFLD patients with a history of diabetes. Therefore, a new
Phase 2 clinical trial was initiated to investigate the effect of
MN-001 (tipelukast) in NAFLD patients with type 2 diabetes and
hypertriglyceridemia.
The molecular mechanism of action of MN-001
(tipelukast) includes leukotriene receptor antagonism and
inhibition of phosphodiesterase (mainly 3 and 4) and 5-lipoxygenase
(5-LO) and these multiple mechanisms are believed to reduce
inflammation and prevent fibrosis. We have also confirmed that
MN-001 (tipelukast) suppresses fibrosis-promoting genes such as
LOXL2, Collagen Type 1, and TIMP-1 and suppresses
inflammation-promoting genes such as CCR2 and MCP-1 in a fibrosis
disease model study. Although the direct mechanism of action of
MN-001 (tipelukast) on TG reduction in blood has not yet been fully
clarified, we are conducting joint research with Juntendo
University with the aim of elucidating this mechanism of
action.
In various animal models of fibrosis disease,
MN-001 (tipelukast) has been shown to improve fibrosis on
histopathological examination, and the FDA has granted Fast Track
status to MN-001 (tipelukast) for the treatment of NASH with
fibrosis. MN-001 (tipelukast) has also been granted Fast Track
status and Orphan Drug designation for the treatment of idiopathic
pulmonary fibrosis. In the past, we have conducted clinical trials
for MN-001 (tipelukast) for the treatment of bronchial asthma and
interstitial cystitis, and more than 600 patients have been treated
with MN-001 (tipelukast) to date, confirming its good safety and
tolerability profile.
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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