Zalicus Successfully Completes Phase 1 Single Ascending Dose Study With Z944 , A Novel, Oral T-Type Calcium Channel Blocker
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 has
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 has successfully completed a Phase 1 single ascending dose (SAD) clinical study with Z944, its novel, oral, T-type calcium channel blocker. The study results indicate that Z944 was generally well-tolerated and a maximum tolerated dose was achieved. Z944 will advance into a Phase 1 multiple ascending dose (MAD) study in the third quarter of 2012. Assuming Z944 successfully completes the MAD study, Z944 could enter Phase 2 clinical development in the first quarter of 2013. “Based on their unique mechanism of action, T-type calcium channel blockers such as Z944 have the potential to provide relief of pain and other symptoms in patients suffering from acute and chronic inflammatory pain, such as post-operative pain, fibromyalgia and inflammatory bowel syndrome, which are significant disease areas in which novel agents with improved tolerability, efficacy, and long-term safety profiles are needed," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “Zalicus is a leader in the discovery and development of Ion channel blockers, with unique expertise in N and T-type calcium channel and sodium channel blockers, and an emerging pipeline of Ion channel blocker drug candidates, including Z160 our oral, N-type calcium channel blocker which is poised to enter Phase 2a clinical trials in neuropathic pain indications in the third quarter of 2012.” About Z944 and T-type Calcium Channel Blockers Z944, is a novel, oral, T-type calcium channel blocker that has demonstrated preclinical efficacy in multiple inflammatory pain models. A Phase 1 clinical trial evaluating the safety and tolerability of Z944 is ongoing. If Z944 successfully completes this Phase 1 clinical trial, Zalicus is planning to advance Z944 into Phase 2 clinical development. The wide distribution of T-type calcium channels found in brain, heart, endocrine cells and other tissues provides the possibility of developing therapeutics for multiple indications, including treatment of pain.
Zalicus (ZLCS) soared Wednesday after the biopharmaceutical company announced it would merge with Epirus Biopharmaceuticals. After the all-stock transaction closes, Zalicus will be known as Epirus and will operate under the latter company's management team led by Amit Munshi as president and CEO. Current Zalicus stockholders will own approximately 19% of the company. The merger will create a publicly-traded company listed on the NASDAQ.