Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported financial results for the second quarter ended June 30, 2013.
“We made significant progress this quarter advancing the clinical development of our novel ion channel programs Z160, a first-in-class, oral, state dependent, selective N-type calcium channel blocker and Z944, a novel oral T-type calcium channel blocker,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “Enrollment is going well in the two Phase 2 clinical trials of Z160 for the potential treatment of chronic neuropathic pain, including lumbosacral radiculopathy and postherpetic neuralgia and we remain on track to report top line data from both studies in the fourth quarter of 2013. In addition, we plan to initiate a Phase 1b study with Z944 in the third quarter of 2013.”
Second Quarter 2013 and Recent Accomplishments:
- Z944. Advancing Z944, a novel oral T-type calcium channel (Cav 3.1-3.3) blocker, into further clinical development for the treatment of pain in the third quarter of 2013. The planned Phase 1b study is a state-of-the-art experimental clinical model utilizing Laser-Evoked-Potentials (LEP) to provide an efficient and objective assessment of the activity of Z944 in an induced neuropathic pain state. Results from the LEP study can further inform Zalicus’s development plans for Z944 in a variety of potential pain indications.
- Z160. Granted a patent by the U.S. Patent and Trademark office (USPTO) covering novel formulations of Z160 and extending its patent protection and exclusivity into 2032. The patent provides broad coverage for a range of novel Z160 pharmaceutical compositions and methods of using these compositions in the treatment of pain. Z160 is a first-in-class, oral, state dependent, selective N-type calcium channel (Cav 2.2) blocker currently in two Phase 2 clinical trials for the potential treatment of chronic neuropathic pain, including lumbosacral radiculopathy 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 on the same primary endpoint measuring changes in weekly mean pain score using a numerical rating scale compared to placebo are expected to be available in the fourth quarter of 2013.
- Scientific Presentations. Presented data highlighting the benefits of Z160 and Z944 at the 32 nd Annual Scientific Meeting of the American Pain Society. These data demonstrated the significant progress Zalicus has made in validating the activity of Z160 and Z944 in preclinical models of pain.
- Publications. Published data on the benefits of utilizing the Zalicus combination High-throughput Screening (cHTS) technology for the potential treatment of ebolavirus infections. The paper, published in Science and Translational Medicine, describes work conducted by Zalicus and collaborators from the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) and the University of Virginia School of Medicine to screen and identify drugs with antifilovirus activity.
- Ongoing Financing. Secured a new funding commitment from Lincoln Park Capital in which Zalicus has the right to sell up to $25 million in shares of its common stock at prevailing market prices at the time of sales.
Second Quarter Financial Results (Unaudited):As of June 30, 2013, Zalicus had cash, cash equivalents, restricted cash and short-term investments of $20.8 million compared to $26.1 million as of March 31, 2013.
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