He brings a wealth of financial and corporate development experience and I look forward to working with him again and building Zynerba into a leading specialty pharmaceutical company,” said Armando Anido, Chairman and CEO. “We also welcome Dr. Nancy Tich, who joined us in June, to our clinical team. She brings nearly three decades of experience to her role as Vice President, Clinical, and her knowledge will be invaluable as Zynerba advances its lead product candidate in the clinic.”
Mr. Anido continued, “We deeply appreciate Rick Baron’s numerous contributions, particularly his leadership through our listing on the Nasdaq in August 2015. On behalf of the entire company, we thank Rick for his financial expertise and friendship. We wish him much success as he pursues new personal and professional endeavors.”
Clinical Highlights from the Second Quarter 2016
Initiated Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial for ZYN002 CBD gel in refractory epilepsy: Zynerba initiated the baseline phase of the STAR 1clinical study in refractory epilepsy patients with focal seizures in June. The Company announced in August that patients had begun randomization and dosing. The STAR 1 trial expects to enroll up to 180 refractory epilepsy patients who will receive either 97.5 mg of ZYN002 4.2% CBD gel, 195 mg of ZYN002 4.2% CBD gel, or placebo gel twice daily. The primary endpoint will assess the median percentage change in seizure frequency over the 12-week treatment period. Safety and tolerability will also be evaluated. Top line results are expected to be reported in the first half of 2017.
Reported top line results from a 7-day Phase 1 Multiple Rising Dose trial for ZYN002 CBD gel: The 7-day Phase 1 trial included 24 healthy volunteers ranging from 25 to 53 years old and 12 epilepsy patients from 19 to 65 years old. These results confirmed that ZYN002 CBD gel was safe and well-tolerated at all dose levels ranging from 200 to 500 mg CBD daily in 1% and 2.5% ZYN002 formulations.
Reported top line results from a 14-day Phase 1 Multiple Rising Dose trial for ZYN002 CBD gel: In this trial, 42 healthy volunteers received a range of CBD doses from 395 mg to 504 mg daily in 2.5% and 4.2% ZYN002 formulations for 14 days. ZYN002 was safe and very well tolerated with minimal skin erythema. The 4.2% formulation demonstrated a comparable pharmacokinetic and tolerability profile to the 2.5% concentration and was easier to use due to its lower volume.
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