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Kai initiates enrollment in Phase I study of pain drug

Kai Pharmaceuticals has started enrollment in a Phase I clinical study of KAI-1678, a first-in-class, isozyme-selective inhibitor of the epsilon protein kinase C pathway.

Kai’s randomized, double-blind, placebo-controlled, rising single-dose study will evaluate the safety, tolerability and pharmacokinetics of KAI-1678 in healthy males. The study will enroll five cohorts and is expected to complete this quarter. The study is being conducted in Australia.

KAI-1678 has been shown to be highly effective at reducing pain responses in a wide variety of preclinical pain models.

Gregory Bell, senior vice president of development and chief medical officer of Kai, said: “Epsilon PKC has been shown to have an important role in both inflammatory and neuropathic pain. Current therapies for the management of pain, such as opioids and nonsteroidal anti-inflammatory drugs, can be limited by side effects and inadequate efficacy. There is a need for novel therapeutics with unique mechanisms of action that provide effective pain relief with reduced side effects.”