Zalicus Inc. (NASDAQ: ZLCS) today reported financial results for the second quarter ended June 30, 2012.
“During the first half of 2012 we made tremendous progress advancing our internal pipeline candidates including the initiation of a multiple ascending dose Phase 1 clinical study with Z944, our novel, oral, T-type calcium channel blocker and second Ion channel program to advance into clinical development,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “Looking forward to the third quarter of 2012 we are on-track to move Z160, our first-in-class treatment for neuropathic pain, into Phase 2a clinical trials and report top-line data results with Synavive.”
Second Quarter 2012 and Recent Accomplishments:
- Completed enrollment in the Synavive® Phase 2b SYNERGY trial, with 259 patients enrolled in the active phase of the study. The SYNERGY clinical trial is designed to evaluate the safety and efficacy of Synavive, a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA). Top-line results of the clinical trial are expected to be available in the third quarter of 2012.
- Advancing Z160, a novel, oral, N-type calcium channel blocker into multiple Phase 2a clinical trials for neuropathic pain indications. Zalicus has selected the most promising formulation for clinical use and is planning to initiate two Phase 2a clinical trials with Z160 this year for the treatment of neuropathic pain, including post-herpetic neuralgia and neuropathic pain from lumbosacral radiculopathy (LSR), a form of chronic lower back pain. The first of these Phase 2a studies in LSR is expected to begin enrolling patients in the third quarter of 2012.
- Initiated a Phase 1 multiple ascending dose (MAD) clinical study with Z944, its novel, oral, T-type calcium channel blocker which has demonstrated efficacy in a number of preclinical inflammatory pain models and other disease models. The initiation of this MAD study follows the successfully completed Phase 1 single ascending dose study in which Z944 was determined to be generally well-tolerated and a maximum tolerated dose was achieved. T-type calcium channels have been recognized as key targets in the therapeutic inhibition of a broad range of cell functions and have been implicated in the frequency and intensity of pain signals. Assuming Z944 successfully completes the MAD study, Z944 could enter Phase 2 clinical development in the first quarter of 2013.
- Extended our alliance with Novartis for an additional contract year, through April 2013, based on the success of the cHTS discovery collaboration up to this point. This is Novartis’ second extension, further validating the value of the cHTS discovery technology to the advancement of novel treatments for cancer.
- Completed our previously announced at-the-market equity offering (ATM) with Wedbush Securities Inc. on August 1, 2012. Since commencing sales under the ATM on June 20, 2012, Zalicus sold a total of 13,091,957 shares of common stock, with net offering proceeds to Zalicus of approximately $14.6 million.