Biotech’s stock goes down in flames after cannabidiol drug failure
pharmafile | August 8, 2017 | News story | Manufacturing and Production, Research and Development | GW Pharma, Zynerba, biotech, cannabidoil, drugs, pharma, pharmaceutical
Zynerba Pharmaceuticals had hoped that its anti-seizure therapy could replicate the kind of success leading competitors had achieved in showing reductions in the number of seizures attained through cannabis-based products. However, it stumbled at the Phase 2 clinical stage – failing to hit any of its targets.
Zynerba’s gel is its lead clinical candidate and was being tested in adult epilepsy patients with focal seizures. The primary endpoint was the reduction of these seizures in the 188 patients involved in the study.
The results found a median reduction of 18.4% in patients taking the lower dose of the gel, while those taking a high-dose had 14% fewer seizures against a placebo reaction of 8.7%.
Secondary endpoints included proportion of patients with ≥50% reduction from baseline in seizure frequency, percent change from baseline in seizure frequency, change from baseline in seizure frequency, seizure-free days, and 100% seizure free – all of which were missed.
Investors did not take the news particularly well, deserting the biotech and leaving its share price reduced by well over half of its price prior to the news.
“We are very disappointed that the STAR 1 trial did not meet its primary endpoint in this patient population,” said Armando Anido, Chairman and CEO of Zynerba. “We are continuing to evaluate this study and the ongoing STAR 2 open label study to determine next steps with ZYN002 in adult epilepsy patients with focal seizures. I’d like to thank the patients, coordinators and investigators, as well as the development team at Zynerba, for their time and energies in conducting this very important trial.”
As mentioned by Anido, the gel will continue to be tested in a further Phase 2 to study the potential use of the therapy in patients with osteoarthritis. With the two indications being very different, there is potential within this study for different results but losing out in epilepsy is a blow.
Another’s company’s loss is another’s gain is true for GW Pharma, a leading company in the use of cannabis-based products for the treatment of seizures, as its shores rose on the news. GW is currently applying for approval of its product, Epidiolex, with the FDA and it was able to show considerable efficacy is trials. In particular, it was able to reduce seizures in those suffering from Dravet syndrome by half in 43% of those tested.
Ben Hargreaves
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