Kai Pharmaceuticals, a drug discovery and development company, has initiated a second Phase IIa study of KAI-1678, an isozyme-selective, small peptide inhibitor of the epsilon protein kinase C pathway.
The study has begun enrollment of patients for the treatment of chronic neuropathic pain associated with chronic postherpetic neuralgia (PHN). In December 2008, Kai announced the initiation of its first Phase IIa study of KAI-1678 in patients with moderate-to-severe postoperative pain following total hip or total knee replacement.
Kai’s Phase IIa PHN study is a double-blind, randomized, placebo- and active-comparator-controlled, single-dose, crossover trial designed to evaluate the efficacy of KAI-1678 administered by subcutaneous infusion. The primary endpoint of the study, which is being conducted in Australia, is the mean change from baseline in pain intensity scores at the end of drug infusion.
Gregory Bell, chief medical officer of Kai, said: Our expanded Phase II program allows us to study KAI-1678, a promising non-opioid, non-steroidal anti-inflammatory drug, in multiple indications in both acute and chronic pain.
Kai is the first company to develop a selective inhibitor of epsilon protein kinase C pathway. We believe there is great potential for this novel approach, which may avoid the side effects and limited efficacy of currently available treatments.