MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ
Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo
Stock Exchange (Code Number: 4875), today announced that Principal
Investigators Leila Gobejishvili, PhD and Craig McClain, MD at the
University of Louisville School of Medicine presented positive
results of the in-vitro and in-vivo studies that evaluated MN-001
(tipelukast, referred to as D46 in the presentation) for its
anti-liver fibrotic effect in human hepatic stellate cells (HSCs)
and in an acute liver injury model at the Liver Meeting Digital
Experience™ 2020 (TLMdX™), the annual meeting of the American
Association for the Study of Liver Diseases (AASLD).
The study was a collaborative effort between
MediciNova, Inc., and Drs. Craig McClain and Leila Gobejishvili,
University of Louisville Alcohol Research Center and Hepatobiology
and Toxicology Centers of Biomedical Research Excellence (COBRE) at
the University of Louisville in Louisville, Kentucky.
This study, funded by the National Institute of
General Medical Sciences (NIGMS), one of the U.S. National
Institutes of Health (NIH), sought to examine the pathogenic role
of phosphodiesterase 4 (PDE4) in hepatic stellate cell (HSC)
activation and TGFβ1 (transforming growth factor beta 1) signaling.
Specifically, the studies evaluated the effect of PDE4 inhibitors
on attenuating fibrotic processes with an emphasis on HSC
activation.
The highlights of the presentation entitled
"Modulation of TGFβ1 signaling by interaction of cAMP effectors and
TGFβ1 type I receptor in hepatic stellate cells" are as
follows:
MN-001 (D46) significantly attenuated
- TGFβ1 induced HSC activation
- TGFβ1 mediated increase in HSC motility and contractility by
reducing myosin light chain (MLC) phosphorylation and
Endothelin-1
- Fibrogenic signaling in a mouse acute carbon tetrachloride
(CCl4) induced liver injury model, specifically,
- MN-001 (D46) decreased CCl4-induced HSC activation demonstrated
by reduced SMAD3 and alpha smooth muscle actin (αSMA) levels
- MN-001 (D46) decreased CCl4-induced liver αSMA, collagen 1a1
and lysyl oxidase 2 mRNA levels
Promoting cAMP signaling by using PDE4
inhibitors could be beneficial in attenuating the development of
liver fibrosis.
Yuichi Iwaki, MD, PhD, President and Chief
Executive Officer of MediciNova, Inc. commented, “We are very
pleased with the positive findings in an acute liver injury model
study conducted by Dr. Gobejishvili and Dr. McClain. This is
additional scientific evidence to support MN-001’s anti-fibrotic
effects in the liver. We look forward to advancing to the next step
to further investigate the potential of MN-001 in liver
fibrosis.”
Dr. McClain, Professor of Medicine, Pharmacology
and Toxicology, Chief of Research Affairs, Division of
Gastroenterology, Hepatology and Nutrition, Director Clinical
Trials Unit / Liver Research Program commented, “We are very
excited to report positive data from our in-vitro and acute liver
injury model study with MN-001 (D46). The attenuation of TGFβ1
signaling for HSC activation and the anti-fibrogenic effect in an
acute liver injury model by MN-001 was very promising. We are
looking forward to further collaboration with MediciNova.”
About MN-001
MN-001 (tipelukast) is a novel, orally
bioavailable, small molecule compound thought to exert its effects
through several mechanisms to produce its anti-inflammatory and
anti-fibrotic activity in preclinical models, including leukotriene
(LT) receptor antagonism, inhibition of phosphodiesterases (PDE)
(mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The
5-LO/LT pathway has been postulated as a pathogenic factor in
fibrosis development, and MN-001's inhibitory effect on 5-LO and
the 5-LO/LT pathway is considered to be a novel approach to treat
fibrosis. MN-001 has been shown to down-regulate expression of
genes that promote fibrosis including LOXL2, Collagen Type 1 and
TIMP-1. MN-001 has also been shown to down-regulate expression of
genes that promote inflammation including CCR2 and MCP-1. In
addition, histopathological data shows that MN-001 reduces fibrosis
in multiple animal models.
About MediciNova
MediciNova, Inc. is a publicly traded
biopharmaceutical company founded upon developing novel,
small-molecule therapeutics for the treatment of diseases with
unmet medical needs with a primary commercial focus on the U.S.
market. MediciNova's current strategy is to focus on BC-PIV
SARS-COV-2 vaccine for COVID-19, MN-166 (ibudilast) for
neurological disorders such as progressive multiple sclerosis (MS),
amyotrophic lateral sclerosis (ALS), degenerative cervical
myelopathy (DCM), substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and glioblastoma
(GBM), as well as prevention of acute respiratory distress syndrome
(ARDS) caused by COVID-19, and MN-001 (tipelukast) for fibrotic
diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic
pulmonary fibrosis (IPF). MediciNova’s pipeline also includes
MN-221 (bedoradrine) and MN-029 (denibulin). For more information
on MediciNova, Inc., please visit www.medicinova.com.
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 BC-PIV SARS-COV-2 vaccine, 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 BC-PIV SARS-COV-2 vaccine, 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, 2019 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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