Zalicus: Z160 Fails To Meet Primary Endpoint In Both Phase 2 Chronic Pain Trials

(RTTNews) - Zalicus Inc. (ZLCS) reported top-line results from two Phase 2 trials of Z160 in chronic pain indications. Z160 failed to meet the primary endpoint in either of the Phase 2 studies in patients with lumbosacral radiculopathy or LSR and post-herpetic neuralgia or PHN. Z160 was shown to be generally safe and well-tolerated with no drug-related serious adverse events, according to the company. Based on these results, Zalicus is terminating the Z160 program and intends to focus efforts on Z944, its novel oral T-type calcium channel modulator in development for the treatment of pain.

Zalicus' President and Chief Executive stated, "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." He added, "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."