Zynerba burned by second trial failure
- Just a week after announcing disappointing topline results for ZYN002 in seizure patients, Zynerba Pharmaceuticals Inc. reported the failure of the drug in another patient population.
- Zynerba revealed Monday morning that ZYN002, a synthetic transdermal cannabidiol gel, failed to demonstrate a statistically significant reduction in knee pain for osteoarthritis patients.
- While the drug failed to meet primary endpoints, there was a trend toward statistical significance in secondary endpoints and in a composite responder analysis.
Despite the trial failure for ZYN002 in osteoarthritis patients, Zynerba seems encouraged by the results and plans to meet with the Food and Drug Administration to discuss a path forward for the drug in the indication.
“Data from the STOP trial will help shape future studies with ZYN002 in osteoarthritis. We will request an end of Phase 2 meeting with the U.S. Food and Drug Administration, which we believe will take place before the end of this year, and plan to move quickly to our pivotal Phase 3 program for ZYN002 in OA,” said Armando Anido, Chairman and CEO of Zynerba.
The Phase 2 STOP trial included 320 patients with confirmed osteoarthritis of the knee who were randomized to a 250 mg does of ZYN002, a 500 mg dose of the drug, or placebo.
Topline results showed that patients on 250 mg of ZYN002 daily achieved a 2.64 mean reduction from baseline in average worst knee pain scores at week 12, while those on the 500 mg dose had a 2.83 mean reduction and patients on placebo achieved a 2.37 mean reduction from baseline.
Secondary endpoints also showed that men responded better to the drug than women.
Shares of Zynerba opened down 20% on Monday to push the stock under $6 per share.
Just last week, Zynerba’s stock dropped nearly 60% after it announced that ZYN002 failed to improve the rate of seizures in patients with epilepsy and focal seizures.
The failures have had a mixed effect on competitor GW Pharmaceuticals, which makes plant-based cannabinoid drugs. While the failure of Zynerba’s lead compound eliminates some of the competition for GW, it also raises questions about how effective cannabinoids can really be in treating pain.
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