Kalypsys Inc. has initiated a second phase I clinical trial of KD7040, a topical inducible nitric oxide synthase (iNOS) inhibitor for the treatment of neuropathic pain.

The company completed a single dose-escalation study in March of this year and expects to compete a multiple dose-escalation study around mid-2007. Together the studies will evaluate the safety, tolerability and pharmacokinetics of KD7040 versus placebo in healthy volunteers.

"The preclinical data for KD7040 suggest that topical administration will help to circumvent some of the typical side effects experienced with pain medications," said Paul Grint, chief medical officer of Kalypsys. "Our initial focus with KD7040 is to investigate the therapeutic effect of the topical gel in Post Herpetic Neuralgia (PHN). Completion of this trial will place us one step closer to the goal of our larger pain programme, which is to develop pain therapies with novel mechanisms that are non-addictive and non-sedating."

KD7040 is the second compound that Kalypsys advanced into the clinic in a six-month period. The company recently completed a phase Ia clinical trial for KD3010 for metabolic disease and plans to initiate a phase Ib clinical trial later this quarter.

KD7040 is a potent, topically administered iNOS inhibitor. It demonstrates robust efficacy in a wide variety of rodent pain models. Importantly, KD7040 exhibits greater than 200-fold selectivity over neuronal NOS and 2000-fold selectivity over endothelial NOS, making the compound a potentially more efficacious treatment for neuropathic pain manifest in diseases such as PHN, diabetic neuropathy, lower back pain and carpal tunnel syndrome.