KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced the company has initiated a third phase 2a study of KAI-1678, a first-in-class, isozyme-selective, small peptide inhibitor of the epsilon protein kinase C pathway (epsilon PKC).
The study has begun enrolment of patients for the treatment of chronic neuropathic pain associated with spinal cord injury (SCI). In December 2008, KAI announced the initiation of its first phase 2a study of KAI-1678 in patients with moderate-to-severe postoperative pain following total hip or total knee replacement. A second phase 2a trial in patients with chronic postherpetic neuralgia was initiated last month.
KAI's phase 2a SCI 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 (SQ) 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.
KAI-1678 has been shown to be highly effective at reversing pain in preclinical models of both neuropathic and inflammatory pain, two applications for which epsilon PKC has been well-validated in the peer-reviewed scientific literature. The company's phase 1 results indicated KAI-1678, a non-opioid, non-NSAID, was safe and well-tolerated in healthy volunteers.
Gregory Bell, KAI's senior vice president of development and chief medical officer, commented, "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 programme, which is the first selective inhibitor of epsilon PKC in clinical trials."
KAI is a drug discovery and development company with multiple, novel clinical-stage programs in cardiovascular disease and pain. KAI's lead product candidate, KAI-9803, is currently in a phase 2b study (PROTECTION AMI) designed to assess the effect of KAI-9803 on reducing myocardial injury in heart attack patients.