Kai Pharmaceuticals, a drug discovery and development company, has initiated a third Phase IIa study of KAI-1678, an isozyme-selective, small peptide inhibitor of the epsilon protein kinase C pathway. The study has started enrollment of patients for the treatment of chronic neuropathic pain associated with spinal cord injury.
Kai’s Phase IIa spinal cord injury 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.
In December 2008, Kai initiated its first Phase IIa study of KAI-1678 in patients with moderate-to-severe postoperative pain following total hip or total knee replacement. A second Phase IIa trial in patients with chronic postherpetic neuralgia was initiated in March 2009.
Gregory Bell, chief medical officer of Kai, said: There is a substantial need for new approaches that can avoid the side effects of current therapies for both acute and chronic pain. We are pleased by the continued momentum of our 1678 program, which is the first selective inhibitor of epsilon protein kinase C pathway in clinical trials.