TorreyPines Therapeutics has announced the completion of a Phase I clinical trial for tezampanel (NGX424), a first-in-class compound in development for the treatment of acute migraine, and plans to move forward with a Phase II clinical trial during the second half of this year.
An AMPA/kainate (AK) receptor antagonist, tezampanel offers a non-opioid, non-vascular approach to the management of migraine and other persistent pain states and represents a promising alternative to current treatments.
The single, ascending, fixed-dose, double-blind and placebo-controlled trial enrolled 110 healthy adult males at one center in the U.S. The primary purpose of the study was to investigate the safety, tolerability and pharmacokinetics of tezampanel in healthy volunteers. Tezampanel, administered subcutaneously, was well tolerated at single doses up to and including 100 mg and pharmacokinetic findings showed the compound was rapidly and completely absorbed.