CeNeRx Initiates Phase II Trial of TriRimaâ„¢ as Monotherapy in Treatment Resistant Depression
RESEARCH TRIANGLE PARK, N.C., Jan. 6, 2011 /PRNewswire/ -- CeNeRx BioPharma, Inc., today reported that it has initiated a Phase II trial of its new formulation of TriRima™, the company's novel antidepressant in development as monotherapy for treatment resistant depression. CeNeRx also announced that it will be presenting atBiotech Showcase™ 2011 onTuesday, January 11, 2011 at 11:00 AM PST.
TriRima is a member of a novel class of drugs known as RIMAs, or reversible and selective inhibitors of monoamine oxidase A (MAO-A). MAO inhibitors achieve superior "triple-action" antidepressant efficacy by elevating the levels of all three of the key neurotransmitters that positively affect mood. However, older MAO inhibitors have been limited by their potential to cause serious cardiovascular side effects when foods containing the naturally occurring substance tyramine are consumed.
TriRima is designed to achieve the efficacy of the MAO inhibitor class while reducing or eliminating the risk of these food-associated effects. In a recently reported "tyramine challenge" study, subjects receiving the new formulation of TriRima showed no signs of any negative effects, even after being exposed to large amounts of tyramine. These positive results further confirmed the good safety profile demonstrated by TriRima in Phase I studies.
The Phase II trial is a double blind, placebo-controlled study designed to assess the efficacy of TriRima administered twice daily as monotherapy in patients with treatment resistant depression. Secondary objectives include evaluating TriRima's safety and tolerability and assessing its pharmacokinetic profile. CeNeRx expects to enroll 360 patients in the study, which is being conducted at multiple centers in the U.S.
"We are eager to test the efficacy of our promising new formulation of TriRima