Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced top-line results from two Phase 2 clinical studies of Z160 in chronic pain indications. Z160 did not meet the primary endpoint in either of the Phase 2 clinical studies in patients with lumbosacral radiculopathy (LSR) and post-herpetic neuralgia (PHN). Z160 was shown to be generally safe and well-tolerated with no drug-related serious adverse events. Based on these results, Zalicus is discontinuing the Z160 program and plans to focus efforts on Z944, its novel oral T-type calcium channel modulator in development for the treatment of pain.
"Despite its promising preclinical profile, Z160 was unable to translate those results into clinical efficacy. A review of the data demonstrate that both studies were conducted in a rigorous fashion and resulted in adequate exposure of Z160, yet failed to demonstrate a difference in effect from placebo on any endpoint," said Mark H.N. Corrigan, MD, President and CEO of Zalicus. "There is a significant unmet need for novel and effective non-opioid based pain therapies, and it was our sincere hope that Z160, with its novel mechanism of action, would offer the potential to provide relief to the millions of patients who suffer from chronic neuropathic pain."