rva Neurosciences Announces Completion Of FDA Review Of Investigational New Drug Application For MIN-202 And Plans For First U.S.-Based Clinical Trial

Minerva Neurosciences, Inc.

, a leader in the development of new therapies to treat neuropsychiatric diseases and disorders, today announced that the U.S. Food and Drug Administration has completed its review of the Investigational New Drug Application for MIN-202, the Company'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 N.V. and Janssen Research & Development, LLC, is being 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 U.S.-based clinical trial for this promising compound," said Rogerio Vivaldi, MD, MBA, Minerva Neurosciences' president and chief executive officer. "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, 3-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 U.S., our development program for MIN-202 will include three separate trials, representing significant progress in advancing this promising compound," said Remy Luthringer, PhD, executive vice president and head of R&D at Minerva Neurosciences.