Zynerba Announces Negative Top-Line Results

GW Pharmaceuticals (GWPH) is an industry leader for a reason…

Developing cannabis-based pharmaceutical treatments is not as easy as it looks and Zynerba Pharmaceuticals (ZYNE) is learning that the hard way.

Zynerba is trading considerably lower after reporting negative top-line results from its double-blind placebo controlled Phase 2 clinical trial evaluating ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with focal seizures.

Zynerba’s Top-Line Data Misses The Mark

Zynerba announced that its Phase 2 clinical trial did not demonstrate statistically significant results during the treatment period.

When compared to the baseline, patients on the low dose of ZYN002 recorded an 18.4% median reduction in focal seizures, while patients on the high dose recorded an 14.0% median reduction and patients on placebo recorded an 8.7% median reduction.

Zynerba Chairman and CEO Armando Anido said, “We are very disappointed that the STAR 1 trial did not meet its primary endpoint in this patient population. 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.”

Although the top-line data was less-than-impressive, CEO Anido believes that the results show that ZYN002 has a favorable safety and tolerability profile, which is encouraging as the firm looks to develop ZYN002 as a treatment for a wide range of indications.

A Story to Watch as Catalysts Lie Ahead

While these results will mostly likely be a headwind for Zynerba in the near-term, the company will present top-line data from its ZYN002 Clinical trial in Osteoarthritis later this month, followed by top-line data from its FAB-C study in Fragile X syndrome before October.

We plan to monitor how the market responds to these results and expect to see the shares give up its gains from Friday. With several data readouts expected in the coming months, we believe Zynerba is a stock to watch.

Keep your eye on this story as we expect Zynerba to trade volatile today!