CeNeRx said that these positive results further confirm the good safety profile demonstrated by TriRima in Phase I studies and set the stage for a Phase II clinical trial as monotherapy in treatment resistant depression, scheduled to begin later this month.
TriRima is a member of a new class of drugs known as RIMAs, or reversible and selective inhibitors of monoamine oxidase A (MAO-A).
CeNeRx’s TriRima is designed to achieve the efficacy of the MAO inhibitor class while reducing or eliminating the risk of these food-associated effects.
In the tyramine challenge study, subjects receiving a modified release formulation of TriRima showed no signs of any negative effects, even after receiving large amounts of tyramine.
CeNeRx chief medical officer Daniel Burch said that the new formulation of TriRima performed well in the tyramine safety study.
"It achieved plasma levels 10-fold higher than our original formulation and drug exposure two to three times greater than the version used in our initial efficacy studies, yet we did not observe any sign of cardiovascular effects, even in the presence of high doses of tyramine administered during peak TriRima exposure," Burch said.
CeNeRx CEO Barry Brand said that TriRima has the potential to be the first monotherapy approved for treatment resistant depression.