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 its plans for a
Phase 3 clinical trial of MN-166 (ibudilast) in progressive
multiple sclerosis (progressive MS) following feedback from the FDA
(U.S. Food and Drug Administration).
Key elements of MediciNova’s Phase 3 clinical trial plan for
MN-166 (ibudilast) in progressive MS include the following:
• MediciNova’s Phase 3 trial will enroll only subjects with
secondary progressive MS without relapses. The rationale for
enrolling this type of progressive MS is the following:
- The FDA agreed that a population of subjects with secondary
progressive MS without relapses is an appropriate target
population.
- MediciNova believes that subjects with secondary progressive MS
without relapses will have the best clinical response to MN-166
(ibudilast) treatment, as compared to other types of progressive
MS. As MediciNova previously reported in April 2019, results
of the subgroup analysis of the SPRINT-MS Phase 2b trial of MN-166
(ibudilast) in progressive MS showed that the trends for reduction
in the risk of confirmed disability progression, as measured by
EDSS, were highest for the subgroup of subjects with secondary
progressive MS without relapses, in which MN-166 (ibudilast)
demonstrated a 46% risk reduction compared to placebo as indicated
by the hazard ratio of 0.538.
- MediciNova believes that the unmet medical need is highest in
subjects with secondary progressive MS without relapses as compared
to other types of progressive MS. Unlike primary progressive
MS and relapsing (or “active”) secondary progressive MS, there are
no drugs approved for long-term treatment of secondary progressive
MS without relapses. In addition, secondary progressive MS
without relapses is the largest subgroup of progressive MS
patients. Based on the data from recently completed clinical
trials in progressive MS, MediciNova believes that more than 80% of
patients with secondary progressive MS do not have relapses.
• The FDA agreed that the primary endpoint of the Phase 3
trial should be time to 3-month confirmed disability progression,
as measured by EDSS (Expanded Disability Status Scale). This
is the same primary endpoint that was used in the Phase 3 trials of
other drugs recently approved for progressive MS.
• MediciNova plans to conduct a single Phase 3 trial.
The FDA acknowledged that a single trial can be the basis for
marketing approval and the acceptability of a single trial to
support drug approval depends on the study results. The two
drugs approved for relapsing (or “active”) secondary progressive MS
in March 2019 were approved by the FDA after conducting a single
Phase 3 trial.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer
of MediciNova, Inc., commented, "We are excited to announce
our Phase 3 plan for MN-166 for progressive MS. Although two
drugs have recently received FDA approval for relapsing
secondary progressive MS, there remains a very large unmet medical
need for secondary progressive MS patients without relapses as the
vast majority of secondary progressive MS patients do not have
relapses and there is still no drug approved for long-term
treatment of these patients. With a convenient oral
administration, a very favorable safety and tolerability profile,
and the potential for better efficacy than other drugs for
progressive MS, we believe ibudilast could become the
best-in-disease drug."
About Progressive Multiple Sclerosis
According to the National MS Society, MS affects
approximately 2.3 million people worldwide. Approximately 85% of MS
patients are initially diagnosed with relapsing remitting MS
(RRMS). Most RRMS patients will eventually transition into
secondary progressive MS (SPMS) in which there are fewer or no
relapses but gradual worsening of neurologic function.
Approximately 15% of MS patients are diagnosed with primary
progressive MS (PPMS) at onset and exhibit gradually increasing
disability in walking, vision, mental acuity, and other bodily
functions without experiencing relapses or remissions. Current
therapies for MS affect the inflammatory response, but provide
limited benefit for the neurodegeneration seen in progressive MS.
There is a significant unmet medical need for agents that may
provide neuroprotection in progressive MS.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a first-in-class, orally bioavailable,
small molecule macrophage migration inhibitory factor (MIF)
inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that
suppresses pro-inflammatory cytokines and promotes neurotrophic
factors. It attenuates activated glial cells, which play a major
role in certain neurological conditions. MN-166 (ibudilast)'s
anti-neuroinflammatory and neuroprotective actions have been
demonstrated in preclinical and clinical studies, which provide the
rationale for treatment of progressive multiple sclerosis (MS),
amyotrophic lateral sclerosis (ALS), and other neurological
diseases such as glioblastoma (GBM), and substance
abuse/addiction. MediciNova is developing MN-166 for
progressive MS, ALS, and other neurological conditions such as
degenerative cervical myelopathy (DCM), glioblastoma, substance
abuse/addiction, and chemotherapy-induced peripheral
neuropathy. MediciNova has a portfolio of patents which
covers the use of MN-166 (ibudilast) to treat various diseases
including progressive MS, ALS, and drug addiction.
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, ALS, degenerative cervical myelopathy (DCM), substance
dependence (e.g., alcohol use disorder, methamphetamine dependence,
opioid dependence) and glioblastoma (GBM), 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 (i) our ability to
successfully complete a Phase 3 clinical trial of MN-166 in
patients with secondary progressive MS without relapses, (ii) our
expectations regarding the FDA regulatory pathway for MN-166,
including our ability to obtain regulatory approval for MN-166 with
a single Phase 3 clinical trial, (iii) subjects with secondary
progressive MS without relapses will continue to respond to MN-166
consistent with our Phase 2 clinical trial results and (iv) our
ability to successfully compete against other approved MS drugs,
assuming we obtain regulatory approval for MN-166. 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, we may
not successfully complete our Phase 3 clinical trial of MN-166 on a
timely basis or at all, risks of obtaining future partner or grant
funding for development of MN-166, MN-221, MN-001, 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, 2018 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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