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news.TorreyPines Therapeutics, a biopharmaceutical company, has announced that oral administration of NGX426, an AMPA/kainate-type glutamate receptor antagonist, has demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia and allodynia compared to placebo following intradermal injections of capsaicin in a human experimental model of cutaneous pain, hyperalgesia and allodynia.
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The single-center, in-clinic, randomized, double-blinded study enrolled a total of 18 healthy male subjects. Using a three-period cross-over design, subjects received two intradermal injections of capsaicin at 30 minutes and 120 minutes after administration of a single, oral dose of 90mg or 150mg of NGX426, or placebo. Pain assessments were determined at specified intervals after each injection of capsaicin and measured by visual analog scale.
According to the company, the 90mg and 150mg doses of NGX426 demonstrated analgesic effect on the primary endpoints. The 150mg dose was statistically significant compared to placebo on all three measures: reduction in spontaneous pain, hyperalgesia and allodynia. The 90mg dose also showed statistical significance on reduction of hyperalgesia and allodynia and trended toward statistical significance on reduction in spontaneous pain.
In addition, a statistically significant pain-reducing effect was observed for the 150mg dose through 4.5 hours post-dosing. NGX426 was well tolerated and all subjects completed the three treatment periods. In order to pursue the Phase II clinical development of NGX426, TorreyPines intends to explore both strategic and financing initiatives.
Ev Graham, CEO of TorreyPines, said: We are very encouraged by these results that show an analgesic effect for NGX426 in this well-accepted pain model. As an oral, non-opioid pain agent, NGX426 could address the significant and documented unmet needs in treating a range of chronic pain conditions including neuropathic pain and acute or prophylactic treatment of migraine. These data, as well as data from our on-going Phase I multiple dose trial, will help us structure our Phase II development plan for NGX426.