MediciNova's repurposed stroke drug missed the mark in a midstage trial testing it in methamphetamine dependence. In the 12-week study, the drug, ibudilast, did not meet its primary endpoint of methamphetamine abstinence during the final two weeks of treatment.
The trial, run by UCLA investigators, involved patients with methamphetamine dependence who were seeking treatment. They were randomized to receive a daily 100-mg dose of ibudilast or placebo for 12 weeks, and had twice-weekly clinic visits for counseling, urine drug tests and safety/medication adherence monitoring, MediciNova said. The trial was designed the detect a statistically significant benefit over placebo on the primary outcome of methamphetamine abstinence, as measured by a urine drug screen in the final two weeks of treatment.
“It is disappointing that the study could not achieve the primary endpoint with this study design and setting," said principal investigator Keith Heinzerling, M.D.
“We will conduct further analyses of the data with UCLA researchers, which will help us to better understand how to optimize study design and setting for any future clinical trials in substance dependence," said MediciNova CEO Yuichi Iwaki, M.D., PhD, in the statement. "We will discuss the results with NIH/NIDA who provided the funding for this trial, the opioid dependence trials and the alcohol dependence trial."
The company will also meet with the FDA after the data reads out from another study in methamphetamine use disorder, Iwaki said.
Ibudilast, a phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor, has been marketed in Japan for nearly 30 years for post-stroke complications and bronchial asthma. Because it suppresses pro-inflammatory molecules and promotes neurotrophic factors, MediciNova is also developing it for substance abuse/addiction, chronic neuropathic pain and neurodegenerative diseases, namely progressive multiple sclerosis and amyotrophic lateral sclerosis (ALS).
Last April, the company announced preliminary data from an open-label study suggesting ibudilast was able to extend survival in ALS patients. And in October, MediciNova reported positive data from a phase 2b trial in progressive MS, showing the drug significantly slowed the progression of brain atrophy in progressive MS patients. About 85% of the 2 million-plus MS patients in the world have the relapsing-remitting form of the disease, with the remaining 15% having the progressive form, which results in steady declines in walking, vision and mental acuity.
MediciNova is chasing Roche's Ocrevus, which in March last year became the first treatment for progressive MS to earn the FDA nod. But while Ocrevus has the first-to-market advantage, MediciNova thinks it can still grab a slice of the market with the orally active ibudilast.