This milestone is based on the positive results of the Tyrima Phase I program reported earlier in 2008 and the recent completion of Pet brain imaging studies showing that Tyrima penetrates the central nervous system and exhibits excellent pharmacokinetic and pharmacodynamic properties.
The first Tyrima Phase II trial is a double-blind, placebo-controlled, multi-center study expected to enroll over 270 patients with major depressive disorder. The study is expected to start before the end of this quarter in 2008.
CeNeRx’s Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A (MAO-A).
CeNeRx has worldwide rights to develop and commercialize Tyrima. This compound, which could be the first RIMA antidepressant available in the US market, has patent protection beyond 2027.