MediciNova Receives Notice of Allowance for New Patent Covering MN-001 and MN-002 for the Treatment of Fibrosis
July 24 2016 - 7:00PM
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 it has
received a Notice of Allowance from the U.S. Patent and Trademark
Office (USPTO) for a pending patent application which covers MN-001
(tipelukast) and MN-002 (a major metabolite of MN-001) for the
treatment of “fibrosis” which includes a broad range of fibrosis /
fibrotic disease in different organs due to different causes.
Once issued, the patent maturing from this allowed patent
application is expected to expire no earlier than June 2035. The
allowed claims cover a method of inhibiting or treating fibrosis
using MN-001 or MN-002.
MediciNova is currently conducting a Phase 2 clinical trial
evaluating MN-001 in idiopathic pulmonary fibrosis (IPF) patients
and another Phase 2 clinical trial evaluating MN-001 in
nonalcoholic steatohepatitis (NASH).
Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.,
commented, "We are very pleased to receive notice that this new
patent will be granted as the claims are broad enough to cover
MN-001 for the treatment of many forms of fibrosis and fibrotic
disease. We believe this patent could substantially increase the
potential value of MN-001 as MN-001’s broad anti-fibrotic activity
enables us to pursue clinical development in various types of
fibrosis in addition to the ongoing clinical studies in NASH and
IPF."
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.
The FDA has granted Fast Track designation to MN-001 for the
treatment of NASH with fibrosis. In addition, the FDA has also
granted MN-001 Orphan-Drug designation and Fast Track designation
for the treatment of IPF. Previously, MediciNova evaluated
MN-001 for its potential clinical efficacy in asthma and had
positive Phase 2 study results. MN-001 has been exposed to more
than 600 subjects and is considered generally safe and
well-tolerated.
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 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, ALS
and substance dependence (e.g., alcohol use disorder,
methamphetamine dependence and opioid dependence), and MN-001
(tipelukast) for fibrotic diseases such as NASH and 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-221, MN-001 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-221, MN-001 and MN-029, 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, 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, 2015 and its subsequent periodic
reports on Forms 10-Q and 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'Brien
Vice President
MediciNova, Inc.
info@medicinova.com
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