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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
“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
In a poster reported at
In a second poster, entitled Safety and Tolerability of ZYN002 (Synthetic Cannabidiol) Transdermal Permeation-Enhanced Gel in Healthy Subjects and Epilepsy Patients: Three Phase 1, Randomized, Double-Blind, Placebo-Controlled Studies (Poster #2.214), results from three Phase 1 studies including a single ascending dose study, a seven-day multiple rising dose study and a 14-day repeat application study in healthy adults and epilepsy patients with focal seizures were reported. A total of 96 healthy adults and 22 epilepsy patients received 50 mg (n = 6), 100 mg (n = 6), 125 mg (n = 6), 200 mg (n=6), 250 mg (n = 43), 395 mg (n=8) 500 mg (n=12) and 504 mg (n=8) of ZYN002 CBD gel versus placebo (n=34). Studies tested once-daily and twice daily application of ZYN002 CBD gel at three concentrations of CBD (1%, 2.5%, and 4.2%, and four volumes of gel (4.7, 5, 6, and 10 g) Application was on clean, dry intact skin of the upper arms and shoulders or upper thighs. Standard safety measures across three studies included physical exams, vital signs, ECGs, safety labs, Columbia Suicide Severity Rating Scale (C-SSRS), adverse events and daily examination of skin for erythema at application site using a 5-point scale.
Transdermal application of ZYN002 administered once or twice daily was safe and well-tolerated at all dose levels tested. Mild, transient, application site events were common for both ZYN002 and placebo gel. Overall, the incidence of adverse events associated with ZYN002 CBD gel was similar to placebo in both healthy volunteers and adult epilepsy patients with focal seizures. After 14 days of ZYN002 administration, there were no reports of somnolence, fatigue or decreased appetite, with one gastrointestinal adverse event reported (nausea). There were also no clinically significant drug related changes during physical exams, on ECG, in vital signs, or in clinical labs.
ZYN002 CBD gel is being evaluated in the ongoing STAR1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) Phase 2 multi-center, double-blind, placebo-controlled, multi-dose clinical trial designed to evaluate the efficacy and safety of ZYN002 in patients with refractory focal seizures. Enrollment is continuing and top-line results are anticipated in the first half of 2017. A multi-center, open-label extension clinical trial, STAR 2, for ZYN002 CBD gel has also launched allowing epilepsy patients with refractory focal seizures who complete the STAR 1 study to receive treatment with ZYN002 CBD gel for up to 52 weeks. A second Phase 2 clinical trial of ZYN002 CBD gel, STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis (OA)), is enrolling patients and is also expected to report top-line results in the first half of 2017. Initiation of a third Phase 2 clinical trial of ZYN002 CBD gel in patients with Fragile X syndrome is planned before year-end 2016 and top line results are anticipated to be released in the first half of 2017.
To view the posters reported at the Annual Meeting of the
About ZYN002 CBD Gel
Zynerba’s ZYN002 CBD gel is the first and only synthetic CBD formulated as a patent-protected permeation-enhanced gel and is being studied in refractory epilepsy, Fragile X syndrome and osteoarthritis. ZYN002 is a clear, permeation-enhanced gel that is designed to provide consistent, controlled drug delivery transdermally with convenient twice-daily dosing. Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with high bioavailability. In addition, transdermal delivery avoids the gastrointestinal tract and potential stomach acid degradation of CBD into THC (associated with psychoactive effects), as demonstrated in a Zynerba in vitro study.
Epilepsy is a disease characterized by an enduring predisposition to generate epileptic seizures (transient symptoms due to abnormal neuronal activity in the brain) and by the neurobiological, cognitive, psychological and social consequences of the condition. Focal seizures usually start in a small area of the temporal lobe or frontal lobe of the brain and quickly involve other areas of the brain that affect alertness and awareness. Approximately 2.2 million patients in the United States and 3.1 million in Europe and Japan battle epilepsy. Focal seizures are the most common type of seizure, with 1.5 million of the 2.2 million adults with epilepsy in the US suffering from focal seizures.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the
Jim Fickenscher, CFO and VP, Corporate Development Zynerba Pharmaceuticals484.581.7483 Fickenscherj@zynerba.com Kimberly Minarovich Argot Partners212.600.1902 firstname.lastname@example.org Media Contact Eliza Schleifstein Argot Partners973.361.1546 email@example.com