Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that it is advancing Z160, its novel, first in class, oral, N-type calcium channel blocker into multiple Phase 2a clinical trials for chronic pain indications. Zalicus has selected the most promising novel, proprietary formulation for clinical use and is planning to initiate two Phase 2a clinical trials with Z160 for the treatment of neuropathic pain; the first of which is expected to begin enrolling patients in the third quarter of 2012.
Zalicus completed Phase 1 pharmacokinetic and safety studies with a number of formulations and has selected the optimal formulation to move into further clinical development. The selected formulation was well tolerated and demonstrated a 6-fold improvement in Z160’s bioavailability compared to the previously studied formulation of Z160.
"The lack of adequate pain control in patients with chronic neuropathic pain represents a significant unmet need and important opportunity for novel agents with improved tolerability, enhanced efficacy, and better long-term safety profiles," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “We look forward to initiating clinical trials with Z160 this year to evaluate its potential for the treatment of neuropathic pain."
About Z160 and N-type Calcium Channel BlockersZ160 is a novel, first in class, state dependent oral N-type calcium channel (Cav 2.2) blocker that has shown efficacy in multiple animal models of neuropathic and inflammatory pain. In addition, Z160 was well tolerated in previously conducted clinical trials involving approximately 200 subjects. N-type calcium channels have been recognized as key targets in controlling pain through modulation of the entry of calcium into neurons. When a pain signal is initiated, calcium channels open and the influx of calcium ions trigger the release of neurotransmitters, which potentiates the signal to the brain where it is perceived as pain. Zalicus has utilized its expertise in this field to successfully discover high affinity, selective and orally available compounds, such as Z160, that show promise for further development as therapies for pain.