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news.TorreyPines Therapeutics, a biopharmaceutical company, has announced that oral administration of NGX426, an AMPA/kainate-type glutamate receptor antagonist, is safe and well-tolerated in healthy male and female subjects when dosed once daily for five consecutive days.
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The Phase I double-blind, placebo-controlled trial enrolled 20 healthy male and female subjects in sequential, dose-escalating cohorts. Subjects received once-daily oral doses of either 90mg or 150mg of NGX426 or placebo for five consecutive days, approximating exposure under steady-state pharmacokinetic conditions. Overall, NGX426 was well-tolerated. There were no dose-limiting adverse events or discontinuations from the study and reported adverse events were generally mild and transient, the company said.
In order to pursue the Phase II clinical development of NGX426, TorreyPines intends to explore financing and strategic alternatives, including a possible project financing, equity financing, partnership, asset out-licensing or sale of the company.
Ev Graham, CEO of TorreyPines, said: The successful completion of this Phase I trial demonstrating the safety and tolerability of NGX426 when dosed over multiple days provides support for pursuing a Phase II program in chronic indications.
Combined with the positive results from our recently completed Phase I study of NGX426 in a capsaicin induced pain model, we are very encouraged about the potential for NGX426 to treat both acute and chronic pain conditions.