Zynerba Pharmaceuticals Reports Positive Initial Results From ZYN002 CBD Gel Phase 1 Single Rising Dose Trial and Initiation of Phase 1 Multiple Rising Dose Trial

Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), a specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced positive initial safety results from its Phase 1 single rising dose clinical trial of its ZYN002 cannabidiol (CBD) gel in development for the treatment of epilepsy, osteoarthritis and Fragile X Syndrome. The Phase 1 study was a randomized, double-blind, placebo-controlled, clinical trial to assess the safety and pharmacokinetics of ZYN002 in 32 healthy volunteers and 12 patients with epilepsy. Initial results from the 32 healthy volunteers demonstrated that ZYN002 was safe and well tolerated at all four dose levels. There were no serious adverse events, no drug-related changes in ECGs or clinical laboratory values, and there were no discontinuations due to adverse events. Overall, the incidence of adverse events associated with ZYN002 was similar to placebo. In addition, ZYN002 demonstrated no impairment in the trail making test, a neuropsychological test of visual attention and task switching, which detects several cognitive impairments. Final results, including results from patients with epilepsy, are expected in the first half of 2016.

The Company also announced the initiation of a second Phase 1 clinical trial for ZYN002. The randomized, double-blind, placebo controlled trial, titled the “Multiple Rising Dose Study in Healthy Volunteers and Patients with Epilepsy,” will evaluate the pharmacokinetic profile and tolerability of ZYN002 in 16 healthy volunteers, followed by 12 patients with epilepsy. Results are expected in the first half of 2016.

“We are making rapid progress in the development of ZYN002 CBD Gel, having initiated the Phase 1 single rising dose trial only two months ago,” said Armando Anido, Chairman and CEO of Zynerba Pharmaceuticals. “Given the positive initial results from the single rising dose study in healthy volunteers, we look forward to the results of the multiple rising dose study in the first half of 2016. There is significant interest in ZYN002 as the first transdermal formulation of CBD with a unique mechanism of action that bypasses the stomach and first pass metabolism in the liver, potentially resulting in increased bioavailability and greater tolerability. Pending the results of these trials, we expect to initiate Phase 2 trials in three indications in the second half of 2016.”