RESEARCH TRIANGLE PARK, N.C., March 13, 2007 /PRNewswire/ -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced top-line results from a Phase I clinical trial of Tyrima(TM), its lead candidate for the treatment of depression and anxiety. In this study, Tyrima was safe and well tolerated. Tyrima is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMAs.
The single-dose, placebo-controlled trial evaluated Tyrima in 41 subjects with doses escalating from 5 mg to 120 mg over the course of the study. Tyrima was well tolerated with no clinically significant adverse events even at the highest dose of 120 mg. Tyrima achieved high plasma concentrations that increased linearly with dose, and the favorable pharmacokinetic half-life should permit once or twice daily dosing. None of the safety and tolerability issues commonly associated with conventional monoamine oxidase A inhibitors (MAOIs) were seen in this study.
"The triple mechanism of MAOI antidepressants has the potential to provide enhanced efficacy to the 30% of patients who do not respond to current therapies, but use of these drugs has been limited by their propensity to cause serious side effects," said Dr. Atul Pande, chief medical officer of CeNeRx. "It is therefore encouraging that Tyrima, a selective and reversible MAO inhibitor specifically designed to avoid these side effects, demonstrated a promising safety profile in its first clinical trial, even at the highest dose. These results provide a strong foundation for proceeding to multiple dose safety studies."
Tyrima's unique mechanism elevates the levels of three key
neurotransmitters (serotonin, norepinephrine and dopamine) that
affect mood and anx