Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today provided a development update for ZYN001 and ZYN002.
Zynerba and its development partner, LTS LOHMANN Therapie-Systeme AG (LTS), a market leader in transdermal therapeutic solutions, are working together to optimize the formulation of ZYN001 into a state of the art drug-adhesive matrix transdermal patch. ZYN001 is a patent-protected pro-drug of THC being developed for the treatment of fibromyalgia and peripheral neuropathic pain. Based on the additional optimization work in progress, Zynerba now expects to begin Phase 1 clinical trials for ZYN001 in the first half of 2017 and Phase 2 clinical trials are now planned to begin during the second half of 2017.
Three Phase 2 clinical trials with ZYN002, the first and only synthetic CBD that is formulated as a patent-protected permeation-enhanced gel, remain on track to report topline results in the first half of 2017. Two Phase 2 clinical trials are ongoing for ZYN002, in adults with refractory epilepsy and in knee pain associated with osteoarthritis. Phase 2 clinical trials in patients with Fragile X Syndrome (FXS) are on track to begin before the end of 2016.
“We are thrilled with the progress made in our development compounds — ZYN002 and ZYN001. Additionally, we are excited with the tremendous progress made by LTS in transforming ZYN001 into an optimized transdermal patch that balances efficacy with patient convenience,” said Armando Anido, Chairman and CEO. “We have completed the development of several prototypes which are smaller and more patient-friendly than our original design and believe that it is appropriate to move to this state of the art patch technology prior to initiating clinical development.”
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage specialty pharmaceutical company focused on developing and commercializing proprietary next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Zynerba is developing therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of two cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid, and tetrahydrocannabinol (THC). Transdermal delivery has the potential to reduce adverse effects associated with oral dosing. ZYN002, the Company’s CBD gel, is the first and only synthetic CBD formulated as a patent protected permeation-enhanced gel. In June 2016, the company initiated the Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial of ZYN002 CBD gel in refractory epilepsy patients with focal seizures. In August 2016, the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial in patients with knee pain due to OA was initiated. A Phase 2 clinical trial in Fragile X syndrome (FXS) is expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical trial for ZYN001 is planned to begin in the first half of 2017. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.