LA JOLLA, Calif., Sept. 2, 2015 (GLOBE NEWSWIRE) — 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 the first advanced ALS patient, using non-invasive ventilation (NIV), has enrolled in the Phase 2 clinical trial evaluating MN-166 (ibudilast) in both early and advanced stage ALS. MediciNova amended the protocol to expand its recruitment to include advanced ALS patients in the trial, and this amendment was approved by FDA (U.S. Food and Drug Administration). The amended protocol now plans enrollment of 60 advanced ALS patients with NIV support in the study in addition to 60 patients without NIV support. Dr. Benjamin Rix Brooks, Director, Carolinas HealthCare System’s Neuromuscular/ALS-MDA Center, is the Principal Investigator of the study.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased to have successfully completed the FDA review period, which allows us to enroll the first advanced ALS patient with NIV support. The safety and efficacy data from advanced ALS patients will be important for our development efforts in ALS and is complementary to the ongoing study that is enrolling ALS patients who are not using NIV.”
About the Study Design
This is a single-center, randomized, double-blind, placebo-controlled, 6-month study designed to evaluate the safety, tolerability and clinical endpoint responsiveness of MN-166 (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in subjects with ALS. The protocol amendment plans for an additional 60 advanced ALS patients, who are on NIV support, to be enrolled in the study. This study consists of two treatment arms, MN-166 and matching placebo, and randomization will occur in a 2:1 ratio (MN-166: placebo). To be eligible, subjects must have a diagnosis of sporadic or familial ALS with onset of less than 10 years from first clinical weakness prior to screening, may be on NIV support, and must be on a stable dose of riluzole for at least 1 month prior to study drug treatment. A total of approximately 120 male and female subjects from 18 to 80 years old, inclusive, will be enrolled (80 subjects in the MN-166 group; 40 subjects in the placebo group). Upon completion of the Double-blind Phase, subjects randomized to the placebo arm will continue for an additional 6 months and will receive open-label MN-166. If there are no safety or tolerability concerns in the MN-166-treated group, a decision will be made to extend participation to the MN-166-treated group into the Open-Label Extension (OLE) Phase. Otherwise, only the placebo-treated patients will participate in the OLE Phase.
The primary objective is to evaluate the safety and tolerability of MN-166 60 mg/day versus placebo when administered for 6 months with riluzole. The secondary objective is to evaluate the clinical endpoint responsiveness of MN-166 60 mg/day versus placebo when administered with riluzole as measured by the following assessments:
- Functional activity as assessed by the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R)
- Respiratory function as measured by slow vital capacity (SVC), Maximum Inspiratory Pressure (MIP) also known as Negative Inspiratory Force (NIF) and Forced Expiratory Volume in 1 second (FEV1) measured under SVC protocol
- Muscle strength measured by manual muscle testing (MMT) and instrumented hand grip dynamometry
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak. As a result, ALS affects voluntary movement and patients in the later stages of the disease may become totally paralyzed. Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 30,000 ALS patients in the U.S. and approximately 5,600 people in the U.S. are diagnosed with ALS each year. Riluzole is the only pharmaceutical treatment approved for ALS, but it has limited efficacy.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova licensed MN-166 (ibudilast) from Kyorin Pharmaceutical Co., Ltd. for potential utility in RRMS. Intellectual property was additionally established or obtained by MediciNova in progressive MS and other neurological conditions. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (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 neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain.
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., methamphetamine dependence and 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-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, 2014 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.
CONTACT: INVESTOR CONTACT: Geoff O'Brien Vice President MediciNova, Inc. firstname.lastname@example.org