Minerva Neurosciences Inc, a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system disorders, provided an update on two ongoing clinical trials with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV. Patient recruitment is ongoing in both trials, which include a Phase 2a trial in insomnia disorder and a Phase 1b trial in adjunctive major depressive disorder (MDD).
“We are pleased with the progress that is being made in the development of MIN-202 in insomnia and adjunctive MDD,” says Remy Luthringer, PhD, president and CEO of Minerva, in a release. “The ongoing trials in these indications are designed to provide assessments of the effects of this compound in sleep and major depressive disorder. We believe that MIN-202 has the potential to physiologically regulate biological rhythm and control of the wake drive based on its unique mechanism of action as a selective orexin-2 receptor antagonist.”
Insomnia Trial (clinicaltrials.gov identifier: NCT02464046)
The Phase 2a trial in insomnia disorder is a randomized, placebo-controlled double-blind study to evaluate treatment with MIN-202 in subjects with insomnia disorder without psychiatric co-morbidity. It is estimated that 26 patients will be enrolled. Half of these patients will receive MIN-202 for 5 days, followed by a washout period and then placebo for 5 days. The other half will receive placebo first, followed by a washout period and then MIN-202 under the same schedule.
The primary endpoint of this trial is sleep efficiency as measured by polysomnography, and secondary endpoints include additional assessments of sleep, mood and cognition, as well as safety. The trial is being conducted at clinical sites in the United States and Europe, and the data readout is expected in the first half of 2016.
Adjunctive MDD Trial (clinicaltrials.gov identifier: NCT02476058)
The Phase 1b trial in adjunctive MDD is a randomized, diphenhydramine- and placebo-controlled double-blind study to evaluate treatment with MIN-202 in subjects with MDD. It is estimated that 48 patients will be enrolled in three groups, which will be treated with MIN-202, diphenhydramine and placebo, respectively, while maintained on their antidepressant regimens.
The primary endpoint of this trial is safety, and secondary endpoints include assessments of depressive symptomology, cognition and sleep. The trial is being conducted at clinical sites in Europe, and the data readout is expected in the first half of 2016.