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Zalicus Inc. (NASDAQ: ZLCS) today reported financial results for the fourth quarter and year ended December 31, 2011.
“In 2011, we made significant progress in advancing our product candidates in clinical development, including Synavive, Z160 and Z944,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “During 2012, we will see the results of those studies and make important decisions on next steps. This is evident with the successful reformulation of Z160, in which we have achieved the consistent exposure levels necessary to evaluate its efficacy in a Phase 2 clinical study for neuropathic pain later this year.”
Fourth Quarter 2011 and Recent Accomplishments:
Ion Channel Programs:
Significant progress has been made with our Ion channel programs this quarter.
Initiated and successfully completed a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160, a novel oral N-type calcium channel blocker. Z160 has been successfully reformulated to achieve 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 neuropathic pain in the second half of 2012.
Initiated a Phase 1 clinical trial evaluating the pharmacokinetics and safety of Z944, a novel oral T-type calcium channel blocker with demonstrated preclinical potential for the treatment of acute and inflammatory pain.
Published preclinical data in the journal Science Translational Medicine, describing the activity of Z944 to potently suppress seizures. This data reinforces the potential biologic activity of Z944, as it is generally understood that conditions of neuronal hyper-excitability, such as epilepsy and pain, are mechanistically linked.
Entered into a collaboration with Hydra Biosciences. The goal of the collaboration is to advance development of Zalicus’ preclinical Ion channel modulator product candidates into clinical development for the treatment of pain. This collaboration brings together the Zalicus portfolio of novel, preclinical Ion channel product candidates, representing multiple calcium and sodium channel modulators, with Hydra’s leadership in Ion channel discovery and preclinical drug development. Hydra’s strong position in this area was recently solidified with the progression into the clinic of its novel TRPA1 modulator for acute pain in collaboration with Cubist Pharmaceuticals. Zalicus’ clinical-stage novel Ion channel modulators currently in Phase 1 clinical development for pain, including Z-160, an N-type calcium channel blocker and Z944, a novel T-type calcium channel blocker, are not included in this collaboration.
2012 Zalicus Pipeline and Business Goals:
Zalicus has set the following goals for 2012, which include internal research and development programs and collaborations:
Complete Phase 2b SYNERGY rheumatoid arthritis clinical trial and report top-line data in the third quarter of 2012
Ion Channel Programs:
Complete Phase 1 PK evaluations of Z160 formulations and initiate Phase 2 clinical study in 2012
Complete Phase 1 evaluation of Z944 and advance into Phase 2 clinical development
Identify new sodium channel development candidate or calcium channel back-up compounds
Continue to execute on existing cHTS™ collaborations and secure new partners
Target year-end ongoing financial strength
Fourth Quarter and Year-End 2011 Financial Results (Unaudited):
As of December 31, 2011, Zalicus had cash, cash equivalents, restricted cash and short-term investments of $49.7 million compared to $46.5 million on December 31, 2010.