MediciNova Initiates Sheep Study under Partnership with BARDA to Develop MN-166 (ibudilast) as a Medical Countermeasure Again...
June 07 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 has
initiated a sheep study to investigate MN-166 (ibudilast) in an
ovine model of chlorine-induced acute lung injury. Following
treatment of the sheep with MN-166 (ibudilast) or control, the
study will evaluate pulmonary function, lung injury and edema
formation, cardiopulmonary hemodynamics, and systemic vascular
permeability.
MediciNova has partnered with 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 work with BARDA
to initiate the first animal model study to evaluate MN-166 as a
potential rapidly-administered treatment for patients exposed to
chemical agents such as chlorine. Under the FDA Animal Rule,
development of medical countermeasures (MCMs) does not require
human clinical trials to establish efficacy when these trials would
not be ethical or feasible. FDA can grant approval of a drug for a
MCM indication based on well-controlled animal studies, when the
results of these studies establish that the drug is reasonably
likely to produce clinical benefit in humans. MN-166 attenuated
histological changes observed in an ARDS mouse model, including
pulmonary edema in lung tissue, and protected against pulmonary
injury by 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 has been funded in whole or in part
with Federal funds from 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 with COVID-19 that are at risk for
developing ARDS.
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
MN-166 (ibudilast) for neurological disorders such as progressive
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 ARDS caused by COVID-19, and MN-001
(tipelukast) for fibrotic diseases such as nonalcoholic
steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). 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 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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