MediciNova to Conduct Mouse Study under Partnership with BARDA to Develop MN-166 (ibudilast) as a Medical Countermeasure Agai...
June 28 2021 - 6:30AM
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 it will conduct
a mouse study to investigate the efficacy of MN-166 (ibudilast) in
a murine model of chlorine-induced lung injury and lethality. After
mice are exposed to chlorine gas and treated with MN-166
(ibudilast) or control, the study will evaluate survival, clinical
outcomes, body weights, lung weights, and upper respiratory tract
histopathology.
This mouse study and the sheep study announced
recently are the result of a partnership between MediciNova and the
Biomedical Advanced Research and Development Authority (BARDA),
part of the Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services, to
repurpose MN-166 (ibudilast) as a potential medical countermeasure
(MCM) against chlorine gas-induced lung damage such as acute
respiratory distress syndrome (ARDS) and acute lung injury
(ALI).
Federico Gaeta, Ph.D., Chief Scientific Officer
of MediciNova, Inc., commented, “We are pleased to reach agreement
to conduct a study in BARDA’s validated mouse model of
chlorine-induced pulmonary injury using higher challenge
concentrations. This will be the second animal model study to
evaluate MN-166 as a potential rapidly administered treatment for
patients exposed to chemical agents such as chlorine. We will
evaluate survival rate, clinical status, and lung histological
changes compared to control mice. In a previous ARDS mouse model
study, MN-166 attenuated histological changes including pulmonary
edema in lung tissue and protected against pulmonary injury by
attenuating the secretion of inflammatory cytokines and reducing
cellular apoptosis in lung tissue. Considering that pulmonary edema
is a hallmark feature of exposure to chlorine, MN-166 has the
potential to improve health outcomes and save lives.”
This project is federally funded in part by the
Department of Health and Human Services; Office of the Assistant
Secretary for Preparedness and Response; Biomedical Advanced
Research and Development Authority, under Contract No.
75A50121C00022.
About MN-166MN-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 for
glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy),
and substance use disorder. In addition, MN-166 (ibudilast) is
being evaluated in patients that are at risk for developing
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, patients at risk of developing acute
respiratory distress syndrome (ARDS), and substance dependence.
MN-001 (tipelukast) is being evaluated in a Phase 2 trial in
idiopathic pulmonary fibrosis (IPF) and is in preparation for a
second Phase 2 trial in nonalcoholic steatohepatitis (NASH).
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 and MN-001. 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 and MN-001, and risks of raising sufficient capital when
needed to fund MediciNova's operations and contribution to clinical
development, risks and uncertainties inherent to the development of
formulations as well as the initiation and conduct of clinical
trials and animal studies, including the potential cost, expected
timing and risks associated with clinical trials and animal studies
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 and animal studies 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 animal studies
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
and animal studies or significant issues regarding the adequacy of
clinical trial and animal study designs or the execution of
clinical trials and animal studies, 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, 2020 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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