Zalicus announced positive results of a Phase 1b clinical study with Z944. The Phase 1b study is an experimental clinical model utilizing Laser-Evoked-Potentials to provide both objective and subjective assessments of the activity of Z944 in induced pain states. Based on these results, Zalicus is planning to advance a modified-release formulation of Z944 into Phase 2 clinical development in an appropriate pain indication in 2014. In addition, a second U.S. patent for Z944 covering methods of treating pain was issued on October 29, providing additional patent protection for Z944 in the U.S. until at least 2029. The study showed statistically significant and meaningful reductions at each of the three doses compared to placebo of overall peak-to-peak amplitude of LEPs in models of both inflammatory and neuropathic pain. Z944 was generally well tolerated with dose dependent CNS side effects and no serious adverse events.
- Pharmaceuticals & Drug Trials