Xenon Provides Key Regulatory Updates on XEN007 and XEN1101
FDA Grants Rare Pediatric Disease Designation to XEN007 for Alternating Hemiplegia of Childhood (AHC); Xenon Eligible to Apply for Priority Review Voucher
IND for XEN1101 Accepted; Site Selection and Patient Enrollment Underway in
XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel inhibitor, which is available in certain countries outside of
The XEN1101 Phase 2b clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Depending upon the rate of enrollment, top-line results from the XEN1101 Phase 2b clinical trial are anticipated in the second half of 2020.
About Alternating Hemiplegia of Childhood (AHC)
AHC is a devastating and life-threatening neurological disease associated with significant morbidity that has substantial impact on day-to-day functioning. AHC presentation includes repeated attacks of hemiplegia involving either side of the body or episodes of quadriplegia, paroxysmal disturbances including tonic or dystonic spells, and developmental deterioration and neurologic abnormalities, which all initially present before 18 months of age. Oculomotor features have been documented to occur within one or two days after birth, with onset of hemiplegia and dystonia occurring as early as one month after birth. AHC children suffer from debilitating painful paroxysmal events that can last for days or weeks and fixed non-paroxysmal symptoms. A recent study conducted nationwide in
We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders, including rare central nervous system (CNS) conditions. We are advancing a novel product pipeline of neurology therapies to address areas of high unmet medical need, with a focus on epilepsy. For more information, please visit www.xenon-pharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN1101, XEN007 and our other product candidates, the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN1101, XEN007 and our other product candidates, the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN1101, XEN007 and our other product candidates, the efficacy of our clinical trial designs, our ability to successfully develop and achieve milestones in the XEN1101, XEN007 and other development programs, the timing of results of our interactions with regulators, the potential to advance certain of our product candidates directly into Phase 2 or later stage clinical trials, anticipated enrollment in our clinical trials, the progress and potential of our other ongoing development programs, and the timing of potential publication or presentation of future clinical data. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; regulatory agencies may not permit certain of our product candidates to advance directly into a Phase 2 or later clinical trials or may delay the initiation thereof; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the
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