Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) reported that it will concentrate its measures on rare and near-rare psychiatric and neurological disorders with immense unmet medical needs. This year, the firm plans to advance ZYN002 in a major Phase 2/3 plan in Fragile X syndrome and in Phase II program in refractory epilepsies, counting adult refractory focal epilepsy and DEE in adolescent and pediatric patients. In addition, the firm intends to commence Phase II advancement of ZYN001 in Tourette Syndrome by the close of this year.
Armando Anido, the CEO and Chairman of Zynerba, reported that the choice to concentrate on near-rare and rare psychiatric and neurological disorders is led by a number of vital factors, including the ZYN002 clinical data noted to date in refractory focal epilepsy and FXS and by the opportunities for an efficient and rapid advancement and regulatory approval procedure. They consider that the plan also allows them to maximize the potential for ZYN001 and ZYN002 with an efficient commercial plan, and prospects for consistent pricing across symptoms. All told, they consider they are well positioned to implement on this plan, including having sufficient funds to support operations well into 2019.
Zynerba Pharmaceuticals is presently in Phase 1 advancement of ZYN001, the firm’s patent-protected, pro-drug of THC delivered through a transdermal patch. The firm projects to complete its Phase I evaluation of numerous formulations of ZYN001 in 1H2018. It projects to take ZYN001 into a Phase II clinical study in Tourette Syndrome, a neurodevelopmental disorder highlighted by vocal and motor tics, late in 2H2018.
Zynerba is assessing the prospect for ZYN001 in other near-rare and rare neuropsychiatric indications. The firm is discontinuing its outlay into the capital-intensive pain segment, counting its pursuit of general peripheral neuropathic pain and fibromyalgia indications for ZYN001, following inconsistency with its near-rare and rare neuropsychiatric focus.