MediciNova to Participate in Panel Discussion at the B. Riley FBR Virtual Infectious Disease Summit
July 20 2020 - 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 that Geoffrey
O'Brien, JD/MBA, Vice President and Executive Officer, will
participate in Panel #3: Taming the Severe Disease Presentations at
the B. Riley FBR Virtual Infectious Disease Summit – Therapeutics
Day on Tuesday, July 21, 2020 at 2:10 p.m. ET. The panel will
include a discussion of treatment approaches for COVID-19 including
MediciNova’s development of MN-166 (ibudilast) for prevention of
acute respiratory distress syndrome (ARDS) in patients with
COVID-19. MediciNova recently announced that the
Investigational New Drug Application (IND) for MN-166 (ibudilast)
for prevention of ARDS has been opened with the U.S. Food and Drug
Administration (FDA) and MediciNova was informed by the FDA that
its proposed clinical investigation of MN-166 (ibudilast) for the
prevention of ARDS in patients with COVID-19 may proceed.
About the Trial
Based on review and discussion with FDA, the design of the Phase
2 clinical trial includes the following elements:
- Randomized (1:1), double-blind, placebo-controlled, parallel
group study in hospitalized COVID-19 patients at risk for
developing ARDS and receiving standard-of-care including
anticoagulation therapy.
- Subjects will be randomly assigned to receive up to 100 mg/day
MN-166 or matching placebo for 7 days;
- Patients will be followed up at Days 14 and 28;
- The co-primary objectives include the proportion of subjects
free of respiratory failure, subjects’ change in clinical status
measured by NIAID scale, and plasma cytokine levels after 7 days of
treatment;
- Secondary objectives include safety, tolerability, and the
proportion of subjects free of respiratory failure on Day 14.
Major inclusion criteria for trial eligibility will include
confirmed SARS-CoV-2 infection, oxygen saturation (SpO2) ≤92% on
room air, chest imaging with abnormalities consistent with COVID-19
pneumonia, and at least one risk factor that poses a higher risk
for more severe illness from COVID-19.
About Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) is a frequently
lethal lung condition caused by excessive inflammation for which
there are no effective therapies beyond supportive care. Normally,
the lung exchanges oxygen for carbon dioxide in small airway sacs
called alveoli. In ARDS, there is extensive inflammation and tissue
injury in the alveoli of the lungs, and loss of the surfactant, a
substance necessary for keeping alveoli open. These changes prevent
the lungs from filling properly with air and providing the body
with enough oxygen, causing life-threatening difficulty breathing.
ARDS may develop over a few days, or it can get worse very quickly.
The first symptom of ARDS is usually shortness of breath. Other
signs and symptoms of ARDS are low blood oxygen, shallow, and/or
rapid breathing. Infections are the most common cause of
ARDS. These infections may include the flu, coronavirus,
other viruses, and sepsis. The rate of death in the
hospital is approximately 40% for ARDS patients.
About MN-166
MN-166 (ibudilast) has been marketed in Japan and Korea since
1989 to treat post-stroke complications and bronchial asthma.
MN-166 (ibudilast) is a first-in-class, orally bioavailable, small
molecule phosphodiesterases (PDE) 4 and 10 inhibitor and a
macrophage migration inhibitory factor (MIF) inhibitor that
suppresses pro-inflammatory cytokines and promotes neurotrophic
factors. It attenuates activated glia cells, which play a major
role in certain neurological conditions. Ibudilast's
anti-neuroinflammatory and neuroprotective actions have been
demonstrated in preclinical and clinical study results and provide
the rationale for its therapeutic utility in substance use
disorders, neurodegenerative diseases (e.g., ALS and progressive
MS), and chronic neuropathic pain. MediciNova is developing
MN-166 for various neurological conditions such as progressive MS,
ALS, and substance abuse/addiction.
About MediciNova
MediciNova, Inc. is a publicly traded biopharmaceutical company
founded upon acquiring and 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 multiple sclerosis (MS), amyotrophic
lateral sclerosis (ALS) and substance dependence (e.g., alcohol use
disorder, methamphetamine dependence, opioid dependence) 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) for the treatment of acute exacerbations of asthma
and MN-029 (denibulin) for solid tumor cancers. MediciNova is
engaged in strategic partnering and other potential funding
discussions to support further development of its programs. 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, 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, 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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