The primary objective of this Phase II trial is to evaluate the antidepressant efficacy of Tyrima in patients with confirmed major depressive disorder (MDD). The trial design incorporates a number of features intended to reduce the variability and placebo response often observed in MDD clinical trials.
The randomized, double-blind, placebo-controlled Phase II trial will enroll approximately 272 patients with moderate to severe MDD who will receive either Tyrima or placebo for six weeks. The primary study objective of antidepressant efficacy will be assessed using the Montgomery-Asberg depression rating scale.
Secondary objectives of the study include evaluation of safety, tolerability, and pharmacokinetics of Tyrima. The trial design was supported by a Tyrima Phase I safety database of 106 subjects and a positron emission tomography study that yielded critical insight into the dose-response relationship of Tyrima. A number of patients are already randomized in the trial and initial results are expected by the end of 2009.
CeNeRx has worldwide rights to develop and commercialize Tyrima. This compound, which could be the first reversible inhibitor of monoamine oxidase -A antidepressant available in the US market, has patent protection beyond 2027.
Daniel Burch, chief medical officer of CeNeRx, said: “Tyrima has the potential to be the first triple-action antidepressant with a safety profile appropriate for the treatment of a broad population of patients with depression, and we are committed to generating clinical data from this Phase II trial.”