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news.CeNeRx BioPharma has announced the successful completion of the Phase I clinical program for Tyrima, its lead candidate for the treatment of depression and anxiety.
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Tyrima is a selective and reversible member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A (RIMA). The Phase I program evaluated a range of Tyrima doses in 65 subjects and included acute dose, repeat dose and fed-fasted studies. The repeat dose study results confirmed the positive findings of the acute dose trial that were reported previously. Tyrima was well tolerated, with no clinically significant adverse events reported at any dose. It achieved high plasma concentrations and exhibited a favorable pharmacokinetic half-life consistent with once- or twice-daily dosing.
CeNeRx has worldwide rights to develop and commercialize Tyrima. This compound, which could be the first RIMA antidepressant available in the US market, has patent protection beyond 2027.
Barry Brand, CEO of CeNeRx, said: “Tyrima offers a mechanism of action that is well-precedented and it has novel safety advantages. We look forward to rapidly advancing the Phase II program.”