ZYN002 auspiciously met the primary endpoint and showed clinically allusive improvements
Zynerba to host appointment alarm and webcast today, September 28 at 8:30 am ET
DEVON, Pa., Sept. 28, 2017 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty biologic aggregation committed to developing and commercializing avant-garde pharmaceutically-produced transdermal cannabinoid treatments, today appear absolute top band after-effects from an accessible characterization basic Appearance 2 FAB-C (Treatment of Fragile X Affection All-overs and Behavioral Challenges with CBD) analytic balloon evaluating ZYN002 cannabidiol (CBD) gel in pediatric and boyish patients with Fragile X affection (FXS). The abstraction auspiciously met its primary endpoint, accomplishing a 46% advance (p<0.0001) in the absolute account of Anxiety, Depression, and Affection Calibration (ADAMS) at anniversary twelve compared to baseline. ZYN002 additionally accomplished clinically allusive improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), which abode the key affection of FXS including amusing avoidance, atmosphere tantrums, repetitive movements, and hyperactivity.
“The abstracts from the FAB-C balloon are absolute agitative and authenticate that ZYN002 may accept a abstruse aftereffect on convalescent abounding of the best disabling affection of Fragile X, such as all-overs and difficult behaviors,” said Steven Siegel, MD, PhD Professor and Chair, Psychiatry and Behavior Sciences, Keck School of Medicine of USC. “Fragile X is a arduous abiogenetic autism spectrum disorder, with circuitous symptomatology that decidedly impacts patients and their families. Abounding accouchement with Fragile X and their families attempt with the abridgement of accustomed drugs to cautiously amusement their symptoms. This abstraction suggests that ZYN002 is accessible for the aing appearance of development, and I accept that this biologic holds abundant affiance as a abeyant analysis for these absolute difficult-to-treat symptoms.”
With these data, Zynerba anticipates that it will accommodated with the U.S. Food and Biologic Administration (FDA) in the aboriginal bisected of 2018 with the ambition of affective bound into a cardinal Appearance 2/3 affairs in pediatric and boyish patients with FXS in 2018. The FDA has accepted Zynerba Orphan Biologic appellation for the use of CBD as analysis of patients with FXS. Orphan Biologic appellation is accepted to atypical drugs that amusement a attenuate ache or action affecting beneath than 200,000 patients in the U.S., and provides allowances including a seven-year aeon of U.S. business exclusivity aloft business approval for the appointed adumbration and may accommodate a accelerated aisle to bazaar authorization.
“We are captivated with the absolute analytic after-effects of ZYN002 in the FAB-C trial; it is a above footfall advanced for the hundreds of bags of patients accepted with Fragile X who currently accept no accustomed ameliorative options to amusement their symptoms,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “The clinically allusive improvements in Fragile X affection and the accomplished tolerability apparent in the FAB-C balloon are compelling. These abstracts will acquiesce us to altercate the alleyway to approval in a affair with the FDA, which we apprehend to booty abode during the aboriginal bisected of 2018. I appetite to acknowledge the patients, families, physicians, abstraction coordinators, and the Zynerba aggregation for their abutment of this important study.”
“The affection of Fragile X can be cutting to a accommodating and caregiver, so I’m absolute agog about the responses to ZYN002 that we saw during this study,” said Honey Heussler, FRACP, Associate Professor at Children’s Bloom Queensland, Medical Director Child Development and advance investigator in the FAB-C study. “These abstracts are acutely promising, decidedly the improvements in anxiety, amusing avoidance, and causticity as abstinent by scales including ADAMS, ABC-FXS, and PARS-R. Tolerability is capital in these patients, so I’m absolute admiring to see that ZYN002 was able-bodied acceptable in Fragile X patients.”
Study DesignTwenty patients (3:1 males) age-old 6 to 17 years of age (mean = 10.7) with Fragile X as accepted by atomic affidavit of FMR1 abounding alteration were enrolled in the accessible characterization FAB-C study. ZYN002 was added on to added medications actuality administered. The aboriginal six weeks of the abstraction were advised to titrate dosing in patients. Dosing was accomplished at 50 mg circadian and could be added to 250 mg daily. Weeks 7 through 12 of the abstraction was a aliment aeon area patients were advised at the dosage accustomed at anniversary six. At the achievement of the study, patients could admission an accessible characterization addendum abstraction for up to 12 months.
Top-line data: Primary endpointThe primary endpoint for the balloon was the change in the absolute account of the Anxiety, Depression, and Affection Calibration (ADAMS) from baseline to anniversary 12. The ADAMS is a 28-item calibration advised to appraise accepted anxiety, amusing avoidance, besetting behavior, manic/hyperactive behavior, and depressed mood. It has been accurate in patients with FXS.
Results for the primary endpoint are abbreviated as follows:
The subscales of ADAMS are as follows:
Top-line data: Accessory endpointsThe Aggregation evaluated assorted accessory endpoints including the Aberrant Behavior Checklist – FXS Specific (ABC-FXS), a Analytic All-around Impression of Advance (CGI-I), the Pediatric All-overs Rating Calibration (PARS-R), Visual Analog Scales for Anxiety, Hyperactivity and Tantrum/Mood Lability, the Vineland Adaptive Behavior III, a Quality of Sleep altitude and the Pediatric Quality of Life (PedsQL™). The after-effects of the accessory endpoints reinforce the after-effects accustomed in the ADAMS.
Results from the ABC-FXS are abbreviated as follows:
Safety dataZYN002 was apparent to be absolute able-bodied tolerated, and the assurance contour was constant with ahead appear abstracts from analytic trials. Two patients discontinued due to deepening of above-mentioned eczema. Four added patients accomplished an adverse event. No adverse contest were advised severe. No accommodating accomplished drug-related GI contest during the 12-week analysis period, and no THC was detected in the plasma. Thirteen of the 18 patients who completed the abstraction accept enrolled in the accessible characterization extension.
Conference alarm informationZynerba management will host a alive appointment alarm and webcast today at 8:30 am Eastern Time to altercate the after-effects of this analytic trial. The alarm can be accessed by dialing (866) 573-0180 (U.S. and Canada) or (430) 775-1345 (international) and referencing appointment ID 90858811. To admission the alive webcast or the replay, appointment the broker folio of the Company’s website at http://ir.zynerba.com/. The webcast will be recorded and accessible on the Company’s website for 30 days.
About Fragile X syndromeFragile X affection is an autism spectrum ataxia affecting 1 in 4,000 males and 1 in 8,000 females. It is the best accepted affiliated bookish affliction in males and a cogent account of bookish affliction in females. It is acquired by a alteration in the Fragile X Mental Retardation gene amid on the X chromosome and leads to dysregulation of the endocannabinoid alleyway including the abridgement in autogenous cannabinoids (2-AG and anandamide). The ataxia abnormally affects synaptic function, bendability and neuronal connections, and after-effects in a spectrum of bookish disabilities, amusing all-overs and anamnesis problems. In the US, there are about 71,000 patients adversity with FXS.
About Our TechnologyCannabinoids are a chic of actinic compounds begin in the Cannabis plant. The two primary cannabinoids independent in Cannabis are cannabidiol, or CBD, and ∆9-tetrahydrocannabinol, or THC. Analytic and preclinical abstracts abutment the abeyant for CBD in alleviative epilepsy, arthritis and Fragile X Syndrome, and THC has absolute furnishings on alleviative pain. Zynerba is developing ameliorative medicines that advance avant-garde transdermal technologies that, if successful, may acquiesce for abiding and controlled commitment of ameliorative levels of CBD and THC. Transdermal commitment of cannabinoids may accept allowances over articulate dosing because it allows the biologic to be captivated through the bark anon into the bloodstream. This avoids first-pass alarmist metaism, potentially enabling lower dosage levels of alive biologic capacity with a college bioavailability and bigger assurance profile. Transdermal commitment additionally avoids the gastrointestinal tract, abbreviation the befalling for GI accompanying adverse contest and the abeyant abasement of CBD by belly acerbic into THC, which may be associated with exceptionable consciousness-expanding effects. Using an accustomed actinic biologic action for manufacturing, Zynerba replicates the CBD and THC begin in the Cannabis plant. We accept that this will acquiesce us to accommodated acrimonious all-around authoritative agencies’ standards while ensuring that we can calmly accumulation the bulk of artefact appropriate to accommodated the appeal of the ample markets that we are targeting.
About ZYN002Zynerba’s ZYN002 CBD gel is the aboriginal and abandoned pharmaceutically-produced CBD formulated as a patent-protected permeation-enhanced gel and is actuality advised in accouchement with Fragile X Syndrome, osteoarthritis and in developed attack patients with focal seizures. ZYN002 is a clear, permeation-enhanced gel that is advised to accommodate controlled biologic commitment transdermally with once- or twice-daily dosing.
About Zynerba Pharmaceuticals, Inc. Zynerba Pharmaceuticals (NASDAQ:ZYNE) is committed to convalescent the lives of bodies with astringent bloom altitude area there is a aerial unmet medical charge by developing and commercializing pharmaceutically-produced transdermal cannabinoid medicines advised to accommodated the accurate adeptness and assurance standards accustomed by all-around authoritative agencies. Through the analysis and development of these life-changing medicines, Zynerba seeks to advance the lives of patients aggressive severe, abiding bloom altitude including epilepsy, Fragile X syndrome, osteoarthritis, fibromyalgia and borderline neuropathic pain. Learn added at www.zynerba.com and chase the Aggregation on Twitter at @ZynerbaPharma.
Cautionary Note on Forward-Looking StatementsThis columnist absolution contains advanced statements aural the acceptation of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use agreement such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or added words that back ambiguity of approaching contest or outcomes to analyze these advanced statements. Such statements are accountable to abundant important factors, risks and uncertainties that may account absolute contest or after-effects to alter materially from the Company’s accepted expectations. For example, there can be no agreement that the Aggregation will access approval for ZYN002 or ZYN001 from the U.S. Food and Biologic Administration (FDA) or adopted authoritative authorities; alike if ZYN002 or ZYN001 are approved, the Aggregation may not be able to access the characterization claims that it is gluttonous from the FDA. In addition, the Company’s banknote and banknote equivalents may not be acceptable to abutment its operating plan for as continued as anticipated. Management’s expectations and, therefore, any advanced statements in this columnist absolution could additionally be afflicted by risks and uncertainties apropos to a cardinal of added factors, including the following: the success, amount and timing of the Company’s artefact development activities, studies and analytic trials; the success of aggressive articles that are or become available; the Company’s adeptness to commercialize its artefact candidates; the admeasurement and advance abeyant of the markets for the Company’s artefact candidates, and the Company’s adeptness to account those markets; the Company’s adeptness to advance sales and business capabilities, whether abandoned or with abeyant approaching collaborators; the amount and amount of bazaar accepting of the Company’s artefact candidates; and the Company’s expectations apropos its adeptness to access and abundantly advance acceptable bookish acreage aegis for its artefact candidates. This account is not all-embracing and these and added risks are declared in the Company’s alternate reports, including the anniversary address on Form 10-K, annual letters on Form 10-Q and accepted letters on Form 8-K, filed with or furnished to the Securities and Exchange Commission and accessible at www.sec.gov. Any advanced statements that the Aggregation makes in this columnist absolution allege abandoned as of the date of this columnist release. The Aggregation assumes no obligation to amend advanced statements whether as a aftereffect of new information, approaching contest or otherwise, afterwards the date of this columnist release.
Zynerba ContactsJim Fickenscher, CFO and VP Corporate [email protected]
Will Roberts, VP Broker Relations and Corporate [email protected]
Media contactTheresa Dolge Tonic Life CommunicationsOffice: [email protected]
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