Zynerba Pharmaceuticals, Inc. ZYNE announced positive top-line results from the open-label phase II BELIEVE 1 study evaluating the efficacy and safety of Zygel, a cannabidiol (CBD) gel treatment, in children and adolescents with a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE).
The study assessed the safety and efficacy of Zygel in various DEEs, including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). A total of 48 patients with confirmed DEE were enrolled in the study and included in the safety data. The number of patients included in the modified intent-to-treat population (mITT) was 46.
The most common and debilitating seizure types in people with epilepsy are focal impaired-awareness and convulsive seizures. Per the study, patients who experienced these seizure types achieved 44-58% monthly median reduction in seizures compared to baseline from month 2 to 6 of treatment with Zygel. Top-line results showed that 46 patients in the mITT population, who had more debilitating type of seizures, experienced a more than 44% median reduction in seizures by month 2, and reductions were sustained through month 6 of the treatment. Among these, 55% of patients experienced a more than 50% median reduction in seizures at month 6 of treatment with Zygel.
However, despite the positive results, shares of the company declined about 21.7% as the percentage of reduction in seizures was less than investors’ expectations. The investors also seem to be concerned about the adverse events. About 96% of the patients experienced a treatment emergent adverse event and 60% experienced a treatment-related adverse event. The study also showed that 10 patients reported a serious adverse event (SAE), and they were mostly infection-related, with two SAEs possibly related to treatment. However, shares of the company have skyrocketed 197.6% year to date against the industry’s decline of 3.8%.
The company also noted that 13 of these 46 patients had a variety of non-focal impaired awareness and non-convulsive seizure types at baseline.
Zacks Rank & Stocks to Consider
Currently, Zynerba is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in thesame space are Dr. Reddy’s Laboratories Ltd. RDY, Evoke Pharma, Inc. EVOK and Agile Therapeutics, Inc. AGRX. While Dr. Reddy’s and Evoke Pharma sport a Zacks Rank #1 (Strong Buy), Agile Therapeutics carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Dr. Reddy’s (RDY) earnings per share estimates have increased from $1.69 to $2.06 for 2019 and from $2.12 to $2.31 for 2020 in the past 60 days.
Evoke’s loss per share estimates have narrowed from 41 cents to 35 cents for 2019 and from 22 cents to 19 cents for 2020 over the past 60 days.
Agile Therapeutics’ loss per share estimates have narrowed from 44 cents to 37 cents for 2019 and from 42 cents to 35 cents for 2020 over the past 60 days.
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