LA JOLLA, Calif., April 26, 2018 (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), announced that principal investigator Dr. Benjamin Rix Brooks, Director, Carolinas HealthCare System’s Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute, will present additional clinical data from MediciNova’s completed clinical trial of MN-166 (ibudilast) in ALS (amyotrophic lateral sclerosis) tomorrow at the American Academy of Neurology (AAN) 70th Annual Meeting in Los Angeles, California.
Highlights of the presentation entitled "Ibudilast – Phosphodiesterase Type 4 Inhibitor – Bi-Modal Therapy with Riluzole in Early [Not Requiring Non-Invasive Ventilation (NIV)] Cohort (EC) and Advanced [Requiring NIV] (ANC) Amyotrophic Lateral Sclerosis (ALS) Patients - Single-Center Adaptive Design Six-Month Double-Blind (DB) - Placebo-Controlled Phase 1b/2a Epoch Followed by Six-Month Open Label Extension (OLE) Epoch, Washout (WO) and Post-Washout Epoch (PWO) - Final Report and Future Directions" include the following:
- A responder was defined as a subject who achieved the composite endpoint of (1) less than 12 unit decline in ALSFRS-R total score at the end of the open-label extension period (i.e. average of less than one unit decline per month over entire 12 month period), and/or (2) less than one MMT unit decline in neck and/or leg muscles at the end of the open-label extension period.
- There was a higher rate of responders in the MN-166 (ibudilast) group compared to the placebo group. 32.4% (11/34) of subjects in the MN-166 (ibudilast) group were responders compared to 11.8% (2/17) of subjects in the placebo group (p=0.11).
- Responders showed improved survival (p=0.0010) in the 30 months post MN-166 (ibudilast) treatment.
- Subjects who completed 6 months or 12 months MN-166 (ibudilast) treatment per protocol showed improved survival (p=0.0025) in the 30 months post MN-166 (ibudilast) treatment.
The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score, which ranges from 0 to 48, measures the functional activity of an ALS subject. ALS subjects decline on the ALSFRS-R total score over time as the disease progresses and their symptoms worsen. Manual muscle testing (MMT), which is graded on a scale from 0 to 5, measures the muscle strength of an ALS subject. ALS subjects decline on the MMT scale over time as the disease progresses and their symptoms worsen.
Dr. Benjamin Rix Brooks, principal investigator, commented, “This composite endpoint provides information that ibudilast may delay ALS progression in some patients and this may benefit survival. The proportion of responders was higher, approximately one in three (11/34), in ALS subjects who started ibudilast rather than placebo during the Double-Blind epoch. This degree of response is more than seen in natural history studies involving thousands of ALS patients in the PRO-ACT database and is greater than those provided by current ALS treatments. Future clinical trials of ibudilast and other treatments in ALS may benefit from use of this novel clinical endpoint in Phase 2 and Phase 3 clinical trials.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with the results of this analysis which indicates that MN-166 may improve survival in this devastating and fatal disease. Based on the positive results from this study, we are planning to discuss the next steps in our development plan with FDA.”
About the ALS Trial
MediciNova, in collaboration with Dr. Benjamin Rix Brooks, Director, Carolinas Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute, evaluated 60mg of MN-166 (ibudilast) per day in early and advanced stage ALS patients. All subjects in the study received 100mg of riluzole per day. This trial was a randomized, double-blind, placebo-controlled study which included a six-month treatment period followed by a six-month open-label extension. The primary endpoint was safety and tolerability and the study also evaluated several efficacy endpoints including functional activity (ALSFRS-R). Data analyzed from the 51 early ALS subjects (the intent-to-treat/ITT population) was presented at the 28th International Symposium on ALS/MND in Boston, MA in December 2017. There was a higher rate of responders on the ALSFRS-R total score, MMT (manual muscle testing) and ALSAQ-5 score (subjective quality-of-life questionnaire) in the MN-166 (ibudilast) group compared to the placebo group. This was the first study of MN-166 (ibudilast) in ALS and the study provides the necessary clinical data for powering assumptions for the next study of MN-166 (ibudilast) in ALS.
About ALS
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 completely paralyzed. Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 20,000 ALS patients in the U.S. and approximately 6,000 people in the U.S. are diagnosed with ALS each year.
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 is developing MN-166 for progressive multiple sclerosis (MS) and other neurological conditions such as ALS and substance abuse/addiction. 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 has a portfolio of patents which cover 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 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 MS, 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-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 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, 2017 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'Brien
Vice President
MediciNova, Inc.
info@medicinova.com