The first Phase 2a clinical study with Z160, which began enrolling patients in August of 2012, is evaluating the activity of Z160 in subjects with pain associated with Lumbosacral Radiculopathy, a chronic neuropathic pain condition resulting from the compression or irritation of the nerve roots exiting the lumbar region of the spine.

2012 Accomplishments:
  • Z160. Advanced Z160, a first-in-class, oral, state dependent, selective N-type calcium channel (Cav 2.2) blocker into two Phase 2a clinical trials for neuropathic pain including lumbosacral radiculopathy (LSR) which began in the third quarter of 2012 and postherpetic neuralgia which began in the fourth quarter of 2012. Top line data from both studies are expected to be available late in the second half of 2013.
  • Z944. Completed Phase 1 single and multiple ascending dose clinical studies with Z944 and are consulting with regulatory authorities on the clinical path forward. Z944 is a novel, oral, T-type calcium channel blocker which has demonstrated efficacy in a number of preclinical inflammatory pain models and other disease models. T-type calcium channels have been recognized as key targets for therapeutic intervention in a broad range of cell functions and have been implicated in pain signaling.
  • Sodium Channel Blockers. Working to discover novel, oral, selective, state-dependent sodium channel blockers. Sodium channel blockers are a promising target linked to chronic pain.
  • Exalgo. A 32mg dosage strength of Exalgo was approved by the FDA in August 2012. We have received over $7.9 million in royalty revenue on Exalgo sales through the quarter ended September 30, 2012.
  • Prednisporin. Sanofi announced its intention to continue Prednisporin development under a third party sublicense. Future potential milestone payments and royalties to Zalicus will remain in place.
  • cHTS. Our combination drug discovery research services business on track to generate approximately $7.0 million of revenue in 2012.

“During 2012, we made a number of advances with our novel ion channel programs, including advancing our novel formulation of Z160 into Phase 2 clinical development and advancing Z944 into the clinic,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “We plan to build on this success in 2013 by generating proof-of-concept data for Z160 in multiple indications and seeking to advance the development of our other ion channel programs.”

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