The US Food and Drug Administration has completed its review of the investigational new drug application for MIN-202, Minerva Neurosciences Inc’s selective antagonist for the orexin-2 receptor in development for the treatment of insomnia. A bioavailability study to advance development of MIN-202, which is being developed by Minerva Neurosciences in collaboration with Janssen Pharmaceutica NV and Janssen Research & Development, LLC, has been initiated by Janssen. The bioavailability study will be the first clinical trial initiated for MIN-202 in the United States.

“We are very pleased that FDA has indicated that the bioavailability study may proceed following their review of the IND for MIN-202, and that we are now in position to initiate the first US-based clinical trial for this promising compound,” says Rogerio Vivaldi, MD, MBA, Minerva Neurosciences’ president and CEO, in a release. “With the recent FDA approval of a dual orexin antagonist for the treatment of insomnia, we are especially encouraged by research indicating that our selective orexin antagonist may be positioned to offer improved specificity and a more adequate pharmacokinetics/pharmacodynamics profile.”

The bioavailability study will be a randomized, open-label, three-way crossover study in healthy male subjects to evaluate the bioavailability, food effect, safety, and tolerability of solid dosage formulation of MIN-202. In addition to this study, Janssen is conducting two other phase 1 studies with MIN-202, including a Phase 1b study in patients suffering from secondary insomnia and major depressive disorder and a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy male and female subjects. The primary objective of the MAD study is to investigate pharmacokinetics data for several doses of MIN-202 after repeated administration and to explore the safety and tolerability of MIN-202 versus placebo during 10 days of consecutive dose administration.

“With the initiation of the bioavailability trial in the US, our development program for MIN-202 will include three separate trials, representing significant progress in advancing this promising compound,” says Remy Luthringer, PhD, executive vice president and head of R&D at Minerva Neurosciences.