Minerva Neurosciences Inc, a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, provided an update on MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV.

Preclinical and single ascending dose clinical data with respect to this compound were presented by Janssen at SLEEP 2015 (Abstract 0009, “Characterization of JNJ-42847922, a selective orexin-2 receptor antagonist, as a clinical candidate for the treatment of insomnia”).

“Based on data from a Phase 1b single-dose study in patients with major depressive disorder (MDD), MIN-202 has a potential favorable pharmacokinetic and safety profile, as well as the pharmacodynamic profile for an insomnia treatment,” says Remy Luthringer, PhD, president and CEO of Minerva, in a release. “Of particular interest, polysomnography data obtained in the Phase 1b study in major depressive patients showed that the selective blockade of orexin-2 by this compound not only accelerated sleep induction and prolonged sleep duration but more importantly also preserved physiologic or restorative sleep. The compound is quickly absorbed to facilitate rapid sleep onset and has an appropriately short half-life, which may avoid daytime sedation. Importantly, in addition to the objective measurements of sleep reported above, there was a statistically significant improvement in quality of sleep as measured by the Stanford Sleepiness Scale in MDD patients suffering from co-morbid insomnia.”

An investigational new drug application (IND) is now in effect to enable the advancement of clinical testing with MIN-202 into Adjunctive MDD. MDD is the most prominent sub-type of depression, and the link with sleep disorder is well established.

“Insomnia is often a key contributor to MDD, and we want to investigate whether treatment of individuals with MDD using an orexin-2 receptor antagonist may forestall or limit frank depressive episodes, not only by improving sleep, but also through the other actions expected from this mechanism,” says Luthringer. “We believe that the MIN-202 IND for adjunctive MDD is an important achievement that will facilitate future IND filings and clinical development, thus allowing us to explore the broader potential of this promising compound.”

Minerva expects that two additional studies with MIN-202 will be initiated in the next several months. These include a Phase 2a study in patients with primary insomnia and a further Phase 1b study in patients with MDD with co-morbid insomnia.