Zalicus Pain Drug Flops in Two Key Clinical Studies

Xconomy Boston — 

Zalicus has been waiting for years to see if its reformulation work on a failed pain drug would lead to success in clinical trials. Unfortunately for the Cambridge, MA-based company, it’s just meant more of the same disappointing results.

Zalicus said today that its experimental pain drug, Z160, missed its mark in two mid-stage clinical trials. Zalicus only presented the top-line results from the studies, but said that Z160 didn’t fare any better than a placebo, and that it is discontinuing development of the drug as a result. It’s a terrible setback for Zalicus, which had been pouring the bulk of its resources into Z160. It’ll now turn its attention to a drug candidate much further behind in development for pain known as Z944.

“Despite its promising preclinical profile, Z160 was unable to translate those results into clinical efficacy,” said Zalicus president and CEO Mark Corrigan, in a statement.

Shares of Zalicus fell off a cliff in pre-market trading, plummeting more than 70 percent.

Z160 is a reformulated version of a drug that Vancouver, BC-based Neuromed, Zalicus’ predecessor, licensed to Merck several years ago. The drug candidate failed in clinical trials, and Merck abandoned it. But Zalicus had contended that the problem was the drug was highly insoluble, making it difficult for the body to absorb.

Zalicus tweaked those properties and charged Z160 into clinical trials. It tested the drug in two like sized, 140-patient mid-stage studies randomly assigning patients either doses of Z160 or a placebo over the course of six weeks. One of those studies dosed patients with post-herpetic neuralgia, or PHN, better known as the chronic nerve pain associated with shingles. The other tested Z160 in patients with lumbosacral radiculopathy (LSR), or chronic lower back pain that comes from the compression of nerves in the base of the spine.

Zalicus was banking on the fact that Z160 would hit its mark in the PHN study, thinking that it would at minimum give the company a sign it may have an effective neuropathic pain drug it could test in other, larger segments of the nerve pain market like diabetic peripheral neuropathy. The LSR study, Corrigan said last week, was more of a “shoot the moon strategy.”

Missing on both studies, however, is the worst-case scenario. Corrigan had said in that event, Zalicus would focus on a “strategic kind of move.” Just weeks ago, Zalicus executed a reverse stock split to bump up its share price. And that was before Z160 fizzled in the clinic.

Zalicus was created by the 2009 merger between CombinatoRx and Neuromed.