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Zynerba Pharmaceuticals (NASDAQ:ZYNE) Stock Tanks After Release Of Disappointing Result On Safety Profile of Zygel



Zynerba Pharmaceuticals (NASDAQ:ZYNE) shares plunged 15% on Wednesday at the back of the announcement of results of the open-label second phase BELIEVE 1 trial. The study is evaluating efficacy and safety of topical cannabinoid Zygel in treating developmental and epileptic encephalopathy. Shared slumped following disappointing results regarding the safety profile of Zygel.

Zynerba CEO says Zygel has a better safety profile

However, CEO Armando Anido has defended the safety profile of Zygel, stating that it has a better safety profile relative to GW Pharmaceuticals’ (NASDAQ: GWPH) epidiolex. In terms of GI tolerability, liver function and drowsiness Zygel is better than Epidiolex while providing the benefit of topical administration. This is better, especially for most patients who find it hard to swallow pills.

Developmental epileptic encephalopathies (DEE) is a rare group of pediatric epilepsy syndromes that include Lennox-Gastau Syndrome and Dravet Syndrome. Children and adolescents with DEE can receive Zygel as a transdermal gel.

Zygel safety and efficacy results

Top-line results from the study indicated 46 patients in the intention to treat population had a more devastating type of seizures. They experienced over 44%mean reductions in seizures from the second month onward using a regular seizure frequency standardized to 28 days.

Around 5% of the patients had more than 55% mean reduction in attacks after six months under Zygel treatment. Zynerba also indicated that 13 out of the 46 patients had a strain of non-focal impaired responsiveness seizures as well as non-convulsive seizure types at baseline. The company noted that the number of individual seizure types in the patients was very same for the company to come up with a definitive conclusion. Therefore further analyses on the same are necessary.

Despite the company indicating that Zygel was well tolerated that was not encouraging enough for investors. Most investors lay their focus on the negative aspects of Zygel rather than the promising efficacy results. The company is planning to complete analysis of data from the study and meet the FDA in the first half of next year to discuss a possible pathway towards approval.

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