CeNeRx BioPharma Announces Positive Phase I Results In First Human Trial Of Third Generation RIMA Antidepressant
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 anxiety, in contrast to the leading antidepressants available today that affect only the single neurotransmitter serotonin. This triple action mechanism has the potential for enhanced efficacy while the selective and reversible nature of RIMAs is intended to avoid toxic side effects.
"The excellent safety profile demonstrated in this study is the first confirmation in humans that Tyrima has the potential to deliver on the promise of the RIMA approach, and these positive results represent an important milestone for our company," said Barry Brand, chief executive officer of CeNeRx. "In contrast to other MAO inhibitors, our third generation RIMA series is designed to bind selectively and reversibly, with the goal of significantly reducing the cardiovascular risks and other side effects typically associated with the MAOI class. These safety results, along with the high plasma levels and favorable pharmacokinetics demonstrated in the study, support advancing Tyrima into a multiple dose safety study in late spring."
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.
The Tyrima Phase l safety trials began in January following a successful review of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration.
About CeNeRx BioPharma
CeNeRx (SEN-er-ex) is a privately held clinical stage company developing and commercializing innovative and improved treatments for diseases of the central nervous system. The company focuses on identifying and developing promising therapeutics to treat diseases related to neurotransmitters, including anxiety, bipolar disorder, dementia, depression, epilepsy, neuropathic pain, schizophrenia, and Parkinson's and Alzheimer's diseases. CeNeRx's most advanced compounds, reversible inhibitors of monoamine oxidase, or RIMAs, are in Phase I and late pre-clinical development for the treatment of major depressive disorder. More information about CeNeRx BioPharma can be found at http://www.cenerx.com/.
CeNeRx BioPharma, Inc.
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