Date: 2015-06-16
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 29th Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2015), June 6-10, 2015
Company: Minerva Neurosciences (USA - MA) Janssen Research & Development, a J&J company (USA - NJ)
Product: MIN-202 (JNJ-42847922)
Action
mechanism: orexin-2 receptor antagonist. MIN-202 is a selective orexin-2 receptor antagonist for the treatment of primary and secondary insomnia. MIN-202 is developed under a co-development and license agreement with Janssen Pharmaceutica N.V., a Johnson & Johnson company.
Disease: comorbid insomnia related to major depressive disorder (MDD)
Therapeutic area: CNS diseases - Neurological diseases
Country:
Trial
details: MIN-202 Phase 1b Study in MDD Patients was a double-blind, placebo-controlled, randomized, four-way crossover, single dose study in 20 male and female patients with MDD and insomnia. The primary endpoint was the effect of MIN-202 (dosed PM) on latency to persistent sleep (LPS). Some additional endpoints were evaluated by PSG (polysomnography). MIN-202 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers was a double-blind, placebo-controlled, randomized MAD study in sequential cohorts of healthy males and females. MIN-202 was administered in the morning at dose levels ranging from 5mg to 60mg for 10 days. MIN-202 Phase 1 Bio-Availability (BA) Study: This third study evaluated treatment with a solid dose formulation of MIN-202 to potentially support additional clinical studies. In this study, similar pharmacokinetic profiles were observed for both formulations, qualifying the solid dose to support further clinical studies.
Latest
news: * On June 16, 2015, Minerva Neurosciences, a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) 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 the 29th Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2015), June 6-10, 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," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "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. 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. * On January 21, 2015, Minerva Neurosciences announced that preliminary results from a Phase 1 clinical study showed that treatment with MIN-202, a selective orexin-2 antagonist, resulted in significant improvements in sleep onset and sleep duration in patients with comorbid insomnia related to major depressive disorder (MDD). Preliminary results from two additional Phase 1 studies also suggest that MIN-202 is well tolerated and possesses advantageous pharmacokinetic and pharmacodynamic features. The three Phase 1 studies were conducted by Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, as part of a collaboration to develop MIN-202 with Minerva that was facilitated by Johnson & Johnson Innovation Ltd in London. I the MIN-202 Phase 1b Study in MDD Patients, the primary endpoint was the effect of MIN-202 (dosed PM) on latency to persistent sleep (LPS). Some additional endpoints were evaluated by PSG (polysomnography). Preliminary results demonstrated a statistically significant effect on LPS in all three doses tested (10, 20, and 40 mg). Treatment with MIN-202 also resulted in prolonged total sleep duration by approximately 45 minutes. In MIN-202 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers, a dose level as low as 5mg was shown to elicit sedation while dose levels >= 20mg induced (daytime) somnolence. MIN-202 plasma exposure was dose proportional from 5mg to 20mg. At higher doses, the exposure was less than dose proportional. In these Phase 1 studies, MIN-202 was found to be generally well tolerated.
