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