Debra Borchardt
Zynerba Pharmaceuticals Inc. (ZYNE) announced 12-month results for its cannabidiol (CBD) gel to treat adults with epilepsy. The data is being presented today at the Emerging Science session of the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles, CA. The company is saying that the data show over the long term that seizures are reduced, yet the placebo effects in the study weren’t published.
“These data continue to suggest that focal seizures may be reduced with longer-term exposure to transdermally-delivered CBD,” said Dr. Liza Squires, Zynerba’s Chief Medical Officer. “In this population of patients, the use of ZYN002 for an additional 12 months in STAR 2 was well tolerated and appeared to result in clinically meaningful seizure reductions both across and within the originally randomized STAR 1 groups. These data continue to provide insight into the potential for ZYN002 in certain epilepsies, and we look forward to initiating a Phase 2b study in adult refractory focal seizures in the second half of 2018.”
In the company’s latest results Zynerba said that compared to baseline, the median changes in seizure rates at months 3, 6, 9, and 12 of STAR 2 across all ZYN002-treated patients at each time point were:
— 25% reduction at month 3 (N=171)
— 36% reduction at month 6 (N=146)
— 49% reduction at month 9 (N=112)
— 58% reduction at month 12 (N=70)
Safety
Zynerba said that the ZYN002 gel was well tolerated with good skin tolerability. The company statement read, “In STAR 2, the most common treatment-emergent AEs (> 7.5%) were upper respiratory tract infection (viral and bacterial [17%]) and headache (11%). One serious AE was considered possibly related to ZYN002 (increased anxiety). There was no clinically significant abnormal liver AEs (i.e. alanine aminotransferase/aspartate aminotransferase) >3x upper limit of normal reported for patients receiving ZYN002.”
Where’s The Placebo Data?
In the STAR 1 results, Zynerba’s study was conducted during a shorter time period and the placebo results weren’t much different from ZYN002’s results. The company stated, “In STAR 1, the change in seizure frequency did not statistically differ between
placebo and both doses of ZYN002.” The placebo results in the STAR 2 study weren’t published in the one-page infographic.
