Zynerba (ZYNE) stock jumped 53% on news that its results from a Phase 2 clinical trial for lead candidate ZYN002 with Fragile-X patients had positive results. The 20-subject study showed a 46% improvement from the baseline and had meaningful improvements in key behavioral characteristics. However, Alfredo Fontanini pointed out on Twitter @AF_biotech that when you look at the chart of the results, the placebo actually performed better than the treatment.
Fontanini provided a chart that wasn’t available through Zynerba’s press release, but he also noted that the MOA or mechanism of action was a positive result and that the company hit a home run there. Still, Fontanini noted that the results were “absolutely, uninterpretable data, worthless for FDA.” The company said it plans to meet with the FDA in the first half of 2018 to discuss a Phase 2/3 study.
GW Pharmaceuticals (GWPH) is off by 11% in early trading after competitor Zogenix (ZGNX) reported positive results for its drug for Dravet syndrome. Zogenix shot up over 140% to lately trade at $31.55 on news that its drug ZX008 reduced seizures. The patient’s seizures dropped significantly more than the placebo and had the longest seizure-free interval. Of course, this has been the disease that GW Pharmaceuticals has been working towards fighting, with so far, no real competition from any other drug players.
GW Pharma’s drug uses cannabis as its base compound, while Zogenix’s ZX008 uses fenfluramine hydrochloride. This was better known as fen-phen and was used as a diet pill before it was taken off the market in the 90’s.
Joseph Sullivan M.D., director of the Pediatric Epilepsy Center in UCSF Benioff Children’s Hospital San Francisco, and Principal Investigator of Study 1 in the U.S. said, “These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of low-dose fenfluramine for patients with Dravet syndrome. If approved, ZX008 could play an important role in treating this devastating condition.”
GW Pharmaceuticals was lately trading at $99.25 and has fallen 23% over the past year after reaching its 52-week high of $137.