Zynerba Pharmaceuticals Announces Initiation of the FAB-C Exploratory Phase 2 Clinical Trial of ZYN002 CBD Gel in Patients with Fragile X Syndrome

DEVON, Pa., Jan. 03, 2017 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that it has initiated the FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) exploratory Phase 2 clinical trial of ZYN002 cannabidiol (CBD) gel in children with Fragile X syndrome. ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery.

Fragile X syndrome (FXS) is an autism spectrum disorder and the most common inherited intellectual disability in males and a significant cause of intellectual disability in females. It is caused by a mutation in the Fragile X Mental Retardation gene located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections and results in a spectrum of intellectual disabilities, social anxiety and memory problems.  In the US, there are about 71,000 patients suffering with FXS.

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Zynerba Reports Positive Results for ZYN002 CBD Gel in Phase 1 Studies at 70th Annual Meeting of the American Epilepsy Society

ZYN002 CBD gel was shown to be safe and well-tolerated across range of doses tested in healthy subjects and adult epilepsy patients with focal seizures
No impairment in cognitive performance or changes in psychological health were observed

DEVON, Pa., Dec. 05, 2016 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced additional results from Phase 1 randomized, double-blind, placebo-controlled single and multiple ascending dose studies of ZYN002 cannabidiol (CBD) gel. These results, which assessed safety, tolerability, and effects on cognition and mood, of ZYN002 CBD gel in both healthy adults and adult epilepsy patients with focal seizures, were reported at the 70th Annual Meeting of the American Epilepsy Society (AES) in Houston, Texas. ZYN002 CBD gel is a patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery in development for the treatment of epilepsy, osteoarthritis and Fragile X syndrome.

“In these first human clinical studies of CBD via transdermal delivery, we are very encouraged that results further demonstrated that ZYN002 CBD gel is safe and well-tolerated in both healthy subjects and adult epilepsy patients with focal seizures across a wide range of doses and concentrations,” said Armando Anido, Chairman and CEO of Zynerba. “Further, we did not observe any difference in cognitive performance or mood changes after treatment with ZYN002 CBD gel. Enrollment in our STAR 1 clinical trial in adult epilepsy patients with focal seizures is continuing and we remain on track to report top-line results in the first half of 2017.”

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Zynerba Pharmaceuticals to Highlight Data for ZYN002 CBD Gel at the 70th Annual Meeting of the American Epilepsy Society

DEVON, Pa., Nov. 28, 2016 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that two posters relating to ZYN002, its patent-protected synthetic CBD gel,  have been selected for presentation at the upcoming 70th Annual Meeting of the American Epilepsy Society, including safety, tolerability and effects on cognition and mood changes in healthy volunteers and adult epilepsy patients with focal seizures. The meeting will be held December 2 – 6, 2016, in Houston, Texas.

“We are encouraged to see that data further supporting the safety profile of ZYN002 were chosen for presentation at this year’s Annual Meeting for the American Epilepsy Society,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “These data demonstrate that ZYN002 CDB gel is safe, well-tolerated and show no psychoactive effects across a wide range of doses. Enrollment in our STAR 1 phase 2 clinical trial for adult refractory epilepsy patients with focal seizures is continuing and we remain on track to report top line results of this trial in the first half of 2017.  Earlier this month, we announced the initiation of our STAR 2 open-label extension trial which will support long-term safety and tolerability of ZYN002 CBD gel in this patient population.”

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Zynerba Pharmaceuticals Announces Initiation of STAR 2 Open-Label Extension Clinical Trial for ZYN002 CBD Gel in Adult Refractory Epilepsy Patients

DEVON, Pa., Nov. 02, 2016 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced the enrollment of the first patients into the STAR 2 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial, an open-label extension trial which allows patients who have completed  the STAR 1 clinical trial to receive treatment with ZYN002 CBD gel for up to 52 weeks.

“STAR 2 is designed to provide additional tolerability and safety information for ZYN002 CBD gel for up to 52 weeks, which we believe will establish that ZYN002 CBD gel is well-tolerated over long-term use,” said Armando Anido, CEO of Zynerba. “Enrollment in STAR 1 is continuing and we plan to report top line results in the first half of 2017.”

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