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Good Epilepsy Data from Zynerba Pharmaceuticals Would Set Stage for Pivotal Trials

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Maxim Group noted that data from Zynerba's Phase 2 proof of concept trial will be released in the third quarter; positive data would set the stage for Phase 3 trials.

Zynerba Pharmaceuticals Inc. (ZYNE:NASDAQ) expects to release data in the third quarter from its Phase 2 STAR (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) trial for ZYN002 in adult refractory focal seizures. In the trial, according to Maxim's March 28 report, the patients "have been randomized to receive 195mg, 390mg, or placebo. The primary end point is median percentage change in seizure frequency over the 12-week treatment period."

"Of 110 patients who have completed the STAR 1 study, 106 patients have enrolled into STAR 2, an open label long-term safety and tolerability study of ZYN002 for up to 52 weeks. After completion of Phase II, the company expects to meet with the FDA to initiate Phase III in the U.S. in 1H18." Maxim stated.

If the STAR 1 results are favorable, Maxim states that it "could count as one of two pivotal trials necessary for approval. . .for focal seizure only, FDA's recent guideline allows for the use of results from the two pivotal trials for children four years and up, requiring only PK and drug interaction study; meaning, a monotherapy trial is not necessary for an indication in children four years and up."

Maxim sees Zynerba as a "tangential play on GW Pharma, with a differentiated mode of delivery (transdermal vs. oral) of the same CBD (cannabidiol). ZYN002 has a better safety and bioavailability profile, and is a synthetic (vs. plant based), which means higher margins and better quality control. Zynerba is also targeting a much larger indication in Epilepsy vs. orphan drug indications for GW Pharma."

Maxim has a 12-month target price on Zynerba of $32. The shares are now trading around $22.

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