MediciNova to Present ALS Study at International Symposium

Biopharmaceutical MediciNova, Inc. will be present at the 26th International Symposium on ALS/MND (amyotrophic lateral sclerosis/motor neurone disease) to host a session on its therapeutic strategies for the treatment of Amyotrophic Lateral Sclerosis (ALS). The company announced it will participate in the symposium to provide preclinical data on MN-166 (ibudilast), its investigational treatment for ALS.

The 26th International Symposium on ALS/MND will be held December 11-13, 2015, in Orlando, FL, and MediciNova will host a presentation on the second day of the conference under the title “Ibudilast, a phosphodiesterase (PDE) 4 and 10 and macrophage migration inhibitory factor (MIF) inhibitor, demonstrates efficacy in two drosophila melanogaster models of ALS.” The session will take place at 6:40 p.m., at the JW Marriott Grande Lakes, Orlando.

MediciNova is working in collaboration with Dr. Benjamin Rix Brooks, who serves as medical director of the Carolinas HealthCare System’s Neuromuscular/ALS-MDA Center, to assess the use of MN-166 in both early and advanced stage ALS patients. The company and the center are currently conducting a randomized, double-blind, placebo-controlled clinical trial that includes a six-month treatment period followed by a six-month open-label extension. The session will be focused on the preclinical results of this study.

Investigators will evaluate numerous efficacy endpoints, such as functional activity (ALSFRS-R), respiratory function, and muscle strength in about 120 ALS patients, half of them with Non-Invasive Ventilator (NIV). Last September, the company announced it was going to enroll the first advanced ALS patient on NIV in the ibudilast trial, stating its fulfilment for engaging in another stage of the studies.

“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,” stated the President and Chief Executive Officer of MediciNova, Yuichi Iwaki, MD, PhD, at the time.

MN-166 is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) 4 and 10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor, able to suppress pro-inflammatory cytokines and promote neurotrophic factors. Treatment with MN-166 attenuated activated glia cells, which are determinant in neurological diseases. Preclinical and clinical study results have already revealed MN-166’s anti-neuroinflammatory and neuroprotective capacities, with a potential use in neurodegenerative conditions like ALS. MN-166 has been available in Japan and Korea since 1989, indicated for the treatment of post-stroke complications and bronchial asthma. MediciNova licensed and later gained MN-166’s intellectual property from Kyorin Pharmaceutical to initially study its use in the treatment of relapse-remitting multiple sclerosis (RRMS).