Company Overview of Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals, Inc. operates as a clinical stage specialty pharmaceutical company. The company focuses on developing and commercializing pharmaceutically-produced transdermal cannabinoid treatments for rare or near-rare neuropsychiatric disorders. Its product candidates include ZYN002, which completed Phase II clinical trial for pediatric and adolescent patients with fragile X syndrome, pediatric and adolescent patients with developmental and epileptic encephalopathies, and adult patients with refractory epileptic focal seizures; and ZYN001 that is in Phase I clinical trial to treat Tourette syndrome. The company was formerly known as AllTranz, Inc. and changed its name to Zynerba ...
80 West Lancaster Avenue
Devon, PA 19333
Founded in 2007
Key Executives for Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals, Inc. does not have any Key Executives recorded.
Zynerba Pharmaceuticals, Inc. Key Developments
Zynerba Pharmaceuticals, Inc. Presents at Jefferies 2018 Global Healthcare Conference, Jun-07-2018 10:30 AM
May 31 18
Zynerba Pharmaceuticals, Inc. Presents at Jefferies 2018 Global Healthcare Conference, Jun-07-2018 10:30 AM. Venue: Ballroom 1, Grand Hyatt New York, 109 E 42nd St, New York, New York, United States. Speakers: Armando Anido, Chairman & CEO.
Zynerba Pharmaceuticals, Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2018; Announces ZYN002 in Fragile X Syndrome
May 8 18
Zynerba Pharmaceuticals, Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2018. For the quarter, the company reported loss from operations of $12,396,136 against $7,703,248 a year ago. Net loss was $12,306,334 against $7,259,021 a year ago. Net loss per share basic and diluted was $0.91 against $0.60 a year ago.
The Company expects to enroll approximately 200 pediatric and adolescent patients in the U.S., Australia and New Zealand into a single pivotal study to support an NDA for ZYN002 in FXS. The primary and key secondary endpoints for the study will assess observable behaviors in patients with FXS as reported by the caregiver using certain subscales of the validated Aberrant Behavior Checklist in Fragile X syndrome (ABC-FXS). Data are expected in 2019. FXS affects approximately 71,000 people in the U.S. It is the leading known cause of inherited intellectual disability and Autism Spectrum Disorder, with symptoms including significant behavioral, social and cognitive deficits. The oral presentation will describe data from the FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) study that highlight the short- and long-term positive impact of ZYN002 on children and adolescents with Fragile X syndrome (FXS). Twelve patients remain in the open label extension of the FAB-C study. As of April 30, 2018, all twelve patients have exceeded nine months on ZYN002, and three have exceeded twelve months. ZYN002 in Developmental and Epileptic Encephalopathies (DEE:) Initiated Phase 2 BELIEVE 1 Clinical Trial in Developmental and Epileptic Encephalopathies (DEE); Topline Results Expected in 2019. Zynerba initiated the six-month BELIEVE 1 (Open Label Study to Assess the Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy) open label multi-dose Phase 2 clinical trial, which will evaluate the efficacy and safety of ZYN002 in approximately 50 children and adolescents with DEE. The primary efficacy assessment is change in seizure frequency. DEE is a heterogeneous group of epilepsy syndromes that involve significant developmental impairment or regression of developmental progress, and are highly resistant to treatment. The category includes a number of syndromes, including Doose, Dravet, Lennox-Gastaut, and West, among others. ZYN002 in Focal Epilepsy: Initiation of Double-Blind, Placebo Controlled Phase 2b Clinical Trial of ZYN002 in Approximately 300 Adult Patients with Refractory Focal Epilepsy is On Track for the Second Half of 2018. Presented Clinical Data from STAR 2 Open Label Study of ZYN002 in Patients with Focal Seizures at the 2018 American Academy of Neurology (AAN) Meeting in Los Angeles, CA. Data show continued improvement in seizure control in adult refractory focal seizure patients receiving ZYN002 through 12 month of open label exposure. Compared to baseline, the median changes in seizure rates at months 3, 6, 9, and 12 of STAR 2 across all ZYN002-treated patients at each time point were: 25% reduction at month 3 (N=171); 36% reduction at month 6 (N=146); 49% reduction at month 9 (N=112); 58% reduction at month 12 (N=70); ZYN002 was well tolerated with good skin tolerability; and There were no clinically significant abnormal liver adverse events >3x upper limit of normal reported for patients receiving ZYN002. ZYN001 in Tourette Syndrome: Continued Dosing in the Phase 1 Program for ZYN001 Pro-drug of Tetrahydrocannabinol (THC) Delivered via Transdermal Patch; Initiation of Phase 2 Study in Patients with Tourette Syndrome (TS) Expected in the Second Half of 2018
Zynerba is executing on a Phase 1 program to assess multiple formulations of ZYN001, a patent-protected, pro-drug of THC delivered via a patch. The Company expects to complete this study in the first half of 2018, and assuming supportive data, move into a Phase 2 clinical trial in Tourette Syndrome late in the second half of 2018.
Zynerba Pharmaceuticals, Inc. Announces Twelve Month ZYN002 Data from Star 2 Study in Patients with Focal Seizures
Apr 25 18
Zynerba Pharmaceuticals, Inc. is reporting new longer term open label clinical data in the Emerging Science session of the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles, CA. The key findings include that responses to ZYN002 in the STAR 2 open label extension, as measured by reductions in focal seizures from the baseline period of STAR 1, are associated with continued treatment with ZYN002. In addition, ZYN002 was shown to be well tolerated through 12 months of treatment in STAR 2. The data presented is, 188 patients were randomized, 186 were analyzed for efficacy, and 174 completed STAR 1; 171 patients continued into STAR 2; As of December 12, 2017, 95 patients remained in the STAR 2 study; Patients were taking a wide range of antiepileptic drugs, the most common of which are levetiracetam, carbamazepine, lamotrigine, lacosamide, and valproate. In STAR 2, longer term exposure to ZYN002 resulted in greater improvements in seizure frequency among all ZYN002-treated patients; Longer term exposure to ZYN002 appeared to result in clinically meaningful reductions in seizures both across and within originally randomized STAR 1 patient groups. ZYN002 was well tolerated with good skin tolerability; In STAR 2, the most common treatment-emergent AEs >7.5% were upper respiratory tract infection and headache 11%; One serious AE was considered possibly related to ZYN002; There were no clinically significant abnormal liver AEs >3x upper limit of normal reported for patients receiving ZYN002.
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