Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced the initiation of the second Phase 3 clinical trial, a multi-national study (Study 1502), for the Company’s lead product candidate, ZX008, as an adjunctive treatment of seizures in children with Dravet syndrome. ZX008 is designated as an orphan drug in both the U.S. and Europe, and received Fast Track designation in the U.S., for the treatment of Dravet syndrome.
“We are excited to begin this clinical trial, as we view ZX008 as an important potential new treatment option for children and adolescents with Dravet syndrome,” said Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven, Belgium (KUL), Head of the Paediatric Neurology Department of the KUL University Hospitals and Director of the Childhood Epilepsy Program at the KUL University Hospitals, and Principal Investigator of the Multi-National ZX008 trial. “This is a devastating epilepsy syndrome and a severely under-served patient population. The open-label clinical data generated to date for ZX008 have been compelling and we look forward to conducting this Phase 3 clinical trial.”
The Phase 3 program for ZX008 includes two randomized, double-blind placebo-controlled studies investigating two dose levels of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum daily dose of 30 mg), as well as placebo. Zogenix intends to enroll 105 subjects in each of the two studies, with 35 patients in each treatment arm. The primary endpoint of both studies is the change in frequency of convulsive seizures as compared to placebo. The key secondary endpoints include 40% and 50% responder analyses, which are important for European regulatory submissions, and the convulsive seizure free interval, which is of significant interest to parents and to patients. The first Phase 3 clinical trial, Study 1501, is currently enrolling patients at sites throughout North America.
“The initiation of Study 1502, which will take place at sites in Western Europe and Australia, represents a significant milestone for Zogenix and our development of ZX008,” said Gail M. Farfel, Ph.D., Chief Development Officer of Zogenix. “We are encouraged by the sustained effectiveness and cardiovascular-related safety data, as well as high levels of sleep quality and quality of life, generated to date for ZX008 in Dravet syndrome in the ongoing open-label study in Belgium.” (Original Source)
Shares of Zogenix closed yesterday at $10.05, down $0.01 or -0.10%. ZGNX has a 1-year high of $21.65 and a 1-year low of $7.90. The stock’s 50-day moving average is $10.11 and its 200-day moving average is $11.00.
On the ratings front, Zogenix has been the subject of a number of recent research reports. In a report issued on May 11, Brean Murray Carret analyst Difei Yang reiterated a Buy rating on ZGNX, with a price target of $28, which represents a potential upside of 178.6% from where the stock is currently trading. Separately, on May 10, Leerink Swann’s Paul Matteis reiterated a Buy rating on the stock and has a price target of $19.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Paul Matteis have a total average return of -6.6% and -6.5% respectively. Yang has a success rate of 45.4% and is ranked #3769 out of 3903 analysts, while Matteis has a success rate of 50% and is ranked #3559.
Zogenix, Inc. is a pharmaceutical company, which is engaged in commercializing and developing products for the treatment of central nervous system disorders and pain with novel drug delivery platforms. The company’s product portfolio includes: Sumavel DosePro, Zohydro and Relday. The Sumavel DosePro product offers fast-acting, easy-to-use subcutaneous administration of sumatriptan for the acute treatment of migraine and cluster headache. The Zohydro product is a 12-hour extended-release formulation of hydrocodone without acetominophen for the treatment of moderate to severe chronic pain requiring around-the-clock opioid therapy. The Relday product is a proprietary, long-acting injectable formulation of risperidone using durect’s SABER controlled-release formulation technology in combination with its DosePro needle-free, subcutaneous drug delivery system.