Zynerba Pharmaceuticals cannabinoid drug for epilepsy missed all of its endpoints costing the company’s stock price more than 55% — and GW Pharma 8.6%.
On Monday, Zynerba Pharmaceuticals, a Pennsylvania-based biotech, announced that its transdermal cannabinoid candidate ZYN002 for refractory epilepsy with focal seizures had not met any of its endpoints in a Phase II trial. Zynerba was not able to show that the drug reduced seizures in the primary endpoint trials, nor that it outperformed a placebo in secondary endpoint trials.
No saving grace may mean the end of the road for ZYN002, but it also raises doubts about the future of cannabinoids to treat epilepsy. This development casts a shadow on the sunny run that companies in the cannabinoid space have been enjoying. GW Pharma, one of the top Cambridge-based biotechs, has built its name on this kind of drug and saw its shares slide 8.6% with the announcement. The company has released a range of encouraging Phase III results from its lead Epidiolex in a rare form of epilepsy, setting the stage for an NDA submission.
While Zynerba’s failure won’t likely stop this momentum (CMO Volker Knappertz reportedly dismissed concerns GW would face similar challenges), it could make the FDA advisory committee hearing a bit more interesting and add to GW’s struggle to get the drug to market. Its filing is already behind schedule — the company initiated a rolling submission when it missed its goal of submitting the NDA by summer — and investors are grumbling about the company’s lack of a partner, as well as fears of a valuation disconnect.
At least GW has one fewer competitor with Zynerba out of the running.
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