A little more than a year since its last lead therapy bit the dust, Zalicus ($ZLCS) today reported that its new lead drug foundered in a pair of mid-stage studies and will join the company's growing scrap heap. The news triggered a rout on Wall Street, with shares in meltdown mode after the news hit.
The Cambridge, MA-based biotech, formerly known as CombinatoRx before it bought out Canada's Neuromed Pharmaceuticals and changed its name in 2010, says it is scrapping the Z160 program after top-line results in the Phase II studies failed to demonstrate a significant improvement over a placebo.
Just a few weeks ago, Zalicus had regained compliance with Nasdaq's $1 minimum rule by executing a 6-for-1 reverse split. Shares closed Friday at $4.61 and swiftly plunged 70% this morning, dropping to $1.49.
Zalicus had to write off Synavive last year after it failed in studies for rheumatoid arthritis. Next up: ZD44, an oral T-type calcium channel modulator also in development to treat pain, which has been a difficult field for drug developers.
"Despite its promising preclinical profile, Z160 was unable to translate those results into clinical efficacy. A review of the data demonstrate that both studies were conducted in a rigorous fashion and resulted in adequate exposure of Z160, yet failed to demonstrate a difference in effect from placebo on any endpoint," said Zalicus CEO Mark Corrigan. "There is a significant unmet need for novel and effective non-opioid based pain therapies, and it was our sincere hope that Z160, with its novel mechanism of action, would offer the potential to provide relief to the millions of patients who suffer from chronic neuropathic pain."
- here's the release