NeurAxon reports positive Phase I data for migraine treatment

NXN-188 is a first-in-class, dual-action, small molecule that is being developed for the treatment of acute migraine and which incorporates both 5-HT agonism (the mechanism of action of triptans, the current standard of care in migraine therapy) and nNOS inhibition.

NeurAxon says NOS is a validated target for migraine therapy as migraine models indicate that nNOS inhibition can relieve pain. Additionally, nitric oxide induces migraines in migraineurs, while the inhibition of NOS has been demonstrated to relieve migraine pain.

The NXN-188 Phase I trial was a randomized, double-blind, placebo-controlled dose escalation study which enrolled healthy volunteers. In the study, nine dose levels were evaluated with subjects receiving single oral doses of either NXN-188 or placebo. Subjects were monitored for adverse events and pharmacokinetic parameters. Results from the trial indicate that NXN-188 was well tolerated, with no drug-related adverse events reported.

“Based on the results of this study, in the third quarter of this year we plan to advance NXN-188 into a Phase IIa clinical proof-of-concept study, which will begin to determine the efficacy and product profile of this candidate,” said Robert Medve, chief medical officer of NeurAxon.

Medve claims that preclinical studies comparing NXN-188 to triptans, the current standard of care in migraine therapy, demonstrated that NXN-188 has multiple potential advantages over triptan therapy. These benefits may include increased efficacy, tolerability, safety, treatment window, response rates and reduced rebound headache.

“Therefore, we believe that a dual action nNOS inhibitor and 5-HT agonist such as NXN-188 could play a significant role in the $3 billion acute migraine market by addressing migraine patients that do not receive complete relief from triptans and thereby potentially expanding the patient population for migraine therapeutics,” concluded Dr Medve.