Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that it has initiated the first of two Phase 2a clinical studies with Z160, its first-in-class, oral, state-dependent, selective N-type calcium channel blocker for the treatment of chronic neuropathic pain indications. This first Phase 2a study will enroll subjects with chronic neuropathic pain associated with Lumbosacral Radiculopathy (LSR). LSR is a common neuropathic pain condition resulting from the compression or irritation of the nerve roots exiting the lumbar region of the spine. Common symptoms include pain radiating from the lower back and down the legs, as well as numbness and tingling in the lower extremities. The prevalence of LSR is high, affecting 3-5% of the global population 1. Currently there are no drug treatments specifically approved to treat this common condition, indicating that LSR is a condition with very high unmet medical need.
Z160 is a state-dependent modulator of the N-type (Cav2.2) calcium channel designed to selectively modulate only those neurons transmitting pain, specifically neurons that are undergoing high-frequency firing. Z160 demonstrated efficacy in several animal models of neuropathic pain. Additionally, phase 1 clinical trials have established Z160 as a very safe and tolerable drug candidate.
A second Phase 2a neuropathic pain clinical study, which is planned to initiate in the fourth quarter of 2012, will evaluate Z160 for the treatment of Postherpetic Neuralgia (PHN), a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, otherwise known as shingles. Top line data for both studies is expected to be available late in the second half of 2013.
"We are excited to move Z160, with its novel mechanism of action, forward into Phase 2a human clinical testing this year," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “While there are a few treatments currently approved for chronic neuropathic pain, there still exists a significant unmet medical need for a more targeted and efficacious therapy with an improved safety and tolerability profile."