MediciNova, a biopharmaceutical company that creates and studies small molecule medications for the management of medical conditions with unmet medical needs, is currently undergoing research on ALS patients who use non-invasive ventilation and will be treated with MN-166, also called Ibudilast, as part of a study on the management of ALS.
Currently there are few medications available to manage the symptoms of ALS (amyotrophic lateral sclerosis), a deadly neurological disease that weakens the motor system of its sufferers so that they eventually require mechanical ventilation and suffer from death due to respiratory failure and related complications.
Amyotrophic lateral sclerosis or ALS is a neurodegenerative condition that affects the motor tracts of the spinal cord and cells of the brain, leading to muscle weakness that progresses to involve the muscles associated with respiration. When the respiratory muscles are affected, the patient often requires mechanical ventilation on a chronic basis. The average lifespan after diagnosis is 2-5 years. One of the only current medications for ALS is riluzole, which unfortunately is not very efficacious. MN-166 is an experimental medication for ALS currently in Phase II trials; it is hoped to provide a higher efficacy when added to riluzole for the treatment of ALS symptoms.
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MediciNova has been evaluating ALS patients and their responsiveness to the drug MN-166, a phosphodiesterase-4 inhibitor, a phosphodiesterase-10 inhibitor and a macrophage migration inhibitory factor inhibitor, believed to improve diseases like ALS by suppressing pro-inflammatory cytokines and by the promoting neurotrophic factors. They are expanding the research to include advanced ALS patients who use non-invasive ventilation and are reporting the enlistment of the first advanced ALS participant in the study.
The study will incorporate 80 participants, including advanced ALS patients, who will receive MN-166 along with an existing drug, riluzole. These participants will be studied along with 40 patients who will receive only riluzole and a placebo, in a double-blind study. They will be evaluated in measurements of respiratory function, functional activity and muscle strength in a Phase II trial. After six months, the placebo arm of the study will be allowed to take MN-166 in an open label trial. Those who are treated with MN-166 in the six month study will also receive additional MN-166 as long as there are no safety or tolerability concerns.
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.”