(NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the successful completion of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160, a novel oral N-type calcium channel blocker. In the study, Z160 demonstrated substantial bioavailability and solubility improvements using a novel, proprietary formulation technology. Based on the data from this study, Zalicus plans to advance Z160 into Phase 2 clinical development for the treatment of neuropathic pain in the second half of 2012. A previous formulation of Z160 was studied in clinical trials of over 200 subjects and was well tolerated.
"We are encouraged by the substantial bioavailability and solubility improvements achieved with the new formulation of Z160 tested in this study,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “These data provides us with the confidence that we can achieve appropriate and consistent exposure levels to evaluate Z160’s efficacy in pain and we look forward to beginning a Phase 2 clinical study in neuropathic pain in the second half of 2012."
About Z160 and N-type Calcium Channel Blockers:
Z160 is a novel oral N-type calcium channel blocker that has shown efficacy in multiple animal models of neuropathic and inflammatory pain, has been well tolerated in Phase 1 and Phase 2a clinical trials in approximately 200 subjects and has been reformulated to address prior bioavailability and food effect issues. N- type calcium channels have been recognized as key targets in the therapeutic inhibition of a broad range of cell functions. Specifically for pain indications, these calcium channels have been recognized as critical for controlling the entry of calcium into neurons. When a pain signal is initiated, calcium channels open and calcium concentration increases, triggering the release of neurotransmitters to the brain where it is perceived as pain and also increasing the general excitability of neurons resulting in the amplification of pain signals. Zalicus has utilized its expertise in this field to successfully discover high affinity, selective and orally available compounds such as Z160 that block N- type calcium channels and that show promise for further development as therapies for pain. Zalicus plans to advance a proprietary formulation of its lead N-type calcium channel product candidate, Z160, into Phase 2 clinical development for neuropathic pain in the second half of 2012.