CeNeRx BioPharma, Inc. has announced the initiation of human clinical trials of Tyrima, CeNeRx's new drug candidate with a triple mechanism of action for the treatment of depression and anxiety.
Tyrima (formerly CX157) is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMA. The Phase I safety trials began this month following a successful review of the Investigational New Drug (IND) application for Tyrima by the U.S. Food and Drug Administration.
"Initiation of human trials for Tyrima is an important milestone for CeNeRx, marking our transition to a clinical stage company," said Barry Brand, chief executive officer of CeNeRx. "Our third generation RIMA series of antidepressant compounds combine a known and effective triple action mechanism that is novel to the U.S., along with an improved safety profile that has been demonstrated in pre-clinical studies. The fact that a first generation RIMA antidepressant is already marketed in Europe significantly decreases the clinical risk associated with this approach, and we look forward to rapidly advancing Tyrima to Phase II trials after successful completion of these initial safety studies."
RIMA antidepressants elevate the levels of three key neurotransmitters that affect mood and anxiety (serotonin, norepinephrine and dopamine), in contrast to the leading antidepressants available today that affect the single neurotransmitter serotonin. This triple mechanism has the potential for enhanced efficacy and an improved therapeutic index compared to current therapies. Tyrima could be the first RIMA antidepressant available in the U.S. market, and it has patent protection through 2026. CeNeRx has worldwide rights to develop and commercialize Tyrima.