KAI’s double-blind, randomized, placebo- and active-comparator-controlled, single-dose study will evaluate the efficacy of KAI-1678 administered by subcutaneous infusion for the treatment of postoperative pain.
The primary endpoint of the study is the difference in pain intensity scores summed over the treatment period in patients with moderate to severe postoperative pain following total hip or total knee replacement. The study will enroll 110 patients and is expected to complete in 2009. The study is being conducted in New Zealand.
According to the company, KAI-1678, a first-in-class, isozyme-selective, small peptide inhibitor of the epsilon protein kinase C pathway (epsilon PKC), has been shown to be highly effective at reversing pain in preclinical models of both neuropathic and inflammatory pain.
Gregory Bell, KAI’s senior vice president of development and chief medical officer, said: We are pleased with the progress of our program for KAI-1678. Novel therapies for pain are needed to avoid the side effects and inadequate efficacy of currently available treatments. KAI-1678 represents a new approach, targeting the epsilon PKC pathway, which has been shown to have an important role in both inflammatory and neuropathic pain.