Minerva Neurosciences Inc, a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders, announced favorable top line results from a Phase 2A clinical trial in insomnia disorder with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV.
“These findings were generated with our selective orexin-2 receptor antagonist, MIN-202, which is designed to physiologically regulate biological rhythm and control of the overactive wake drive,” says Remy Luthringer, PhD, Minerva president and CEO, in a release. “The data indicate that MIN-202 may accelerate sleep induction, restore sleep duration, and preserve key phases of sleep, thus enabling restorative sleep.”
Patients treated with MIN-202 in the Phase 2A trial were observed to have statistically significant improvements in key sleep parameters, compared to patients treated with placebo. These parameters include sleep efficiency as measured by objective polysomnography, the primary endpoint of the trial, for which a positive efficacy signal was detected for 40 mg MIN-202 versus placebo (p<0.001). Additional significant positive efficacy signals were observed for key secondary parameters, including latency to persistent sleep, wake after sleep onset, and total sleep time.
No serious adverse events were observed in this trial, and preliminary data indicate that MIN-202 was well tolerated by patients. The most common treatment-emergent adverse events associated with exposure to MIN-202 during the double-blind phase of the study were somnolence and abnormal dreams.
The trial was conducted at clinical sites in the United States and Europe. Complete results are planned for peer-reviewed presentation in the future.
The Phase 2A trial was a randomized, two way, cross-over, placebo-controlled double-blind study to evaluate the effect of MIN-202 on sleep and daytime functioning in 28 patients with insomnia disorder without psychiatric co-morbidity. Patients were given MIN-202 or placebo in a cross-over design for treatment periods of five days, separated by a washout period.
In addition to this trial, a Phase 1B trial with MIN-202 is ongoing in patients suffering from major depressive disorder. In this trial, MIN-202 is co-administered with an antidepressant compound. Enrollment in this trial has been completed, and top line data are expected in the first quarter of 2016.
Minerva entered into a co-development and license agreement with Janssen in February 2014, covering MIN-202 and any other orexin-2 compounds. Under this agreement, Minerva has an exclusive license to these compounds in the European Union, Switzerland, Liechtenstein, Iceland, and Norway. Janssen has exclusive rights to these compounds worldwide outside of these territories.