CeNeRx BioPharma, Inc., reported that it has initiated a Phase 2 trial of its new formulation of TriRima, the company’s novel antidepressant in development as monotherapy for treatment resistant depression.
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 2 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 in treatment resistant depression, and we are delighted that our Phase 2 trial is now enrolling patients,” said Daniel Burch, MD, Chief Medical Officer of CeNeRx. “The new formulation of TriRima has demonstrated excellent safety in multiple studies to date, and we believe that it has the potential to become the first agent to achieve the triple action efficacy of MAO inhibitor drugs without their limiting side effects.”
The modified release formulation of TriRima has major advantages over the version used in earlier studies. In addition to displaying excellent pharmacokinetic properties, the dosing frequency has been reduced to one tablet administered once or twice daily.
“TriRima addresses a large unmet medical need—currently a substantial proportion of patients with major depression do not receive adequate relief from their therapy,” noted Barry Brand, Chief Executive Officer of CeNeRx. “TriRima has the potential to be the first option that provides these patients superior efficacy and a good safety profile as monotherapy, and we look forward to advancing the Phase 2 trial in the coming year.”
Date: January 6, 2010
Source: CeNeRx BioPharma, Inc.
Filed Under: Drug Discovery
