TorreyPines Therapeutics has initiated a Phase I clinical trial for NGX424,
a novel therapeutic for the treatment of severe migraine and other persistent,
intractable pain states. An AMPA/kainate (AK) receptor antagonist, NGX424 offers
a non-opioid, non-vascular approach to the management of severe pain.
The trial with NGX424 will enroll approximately 90 healthy male volunteers at one center in the U.S. The single, ascending, fixed-dose, study will evaluate the local and systemic tolerability, safety and pharmacokinetics of the drug, as well as the maximum tolerated dose of a subcutaneous formulation.
In previously conducted placebo-controlled, Phase II, proof-of-concept trials, an intravenous formulation of NGX424 achieved positive data in five pain models. In a placebo and active-controlled trial in migraine, NGX424, administered intravenously, achieved statistical significance in all primary and secondary endpoints traditionally required for regulatory approval. These included pain relief at two hours, pain-free at two hours, sustained pain-free state at 24 hours and relief of nausea, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).