BURNABY, British Columbia, June 08, 2016 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, announced that Dr. Simon Pimstone, Xenon's President and Chief Executive Officer, will present today at the Jefferies 2016 Healthcare Conference in New York City at 11:30 am ET.
The presentation will provide a business update, with a focus on the company’s proprietary programs, including its:
- XEN801 program, a topical stearoyl Co-A desaturase-1 (SCD1) inhibitor being developed for the treatment of moderate to severe acne; and,
- development of a Nav1.6 sodium channel inhibitor for the treatment of rare infantile epileptic encephalopathies – such as Dravet Syndrome and SCN8A epilepsy.
Dr. Simon Pimstone, Xenon's President and Chief Executive Officer, commented: “We have made strong progress towards our corporate milestones and advancement of our proprietary therapeutic pipeline. We are currently enrolling patients with moderate to severe acne in our Phase 2 clinical trial for XEN801. By inhibiting SCD1, XEN801 represents a novel approach to treat acne aiming to reduce sebum production and have an effect on both the size and number of sebaceous glands.”
In the XEN801 Phase 1 clinical trial, 48 healthy volunteers were dosed for either a 14-day or 21-day treatment period. A number of different dose volumes of the 1% XEN801 drug product were evaluated in the Phase 1 clinical trial with dosing on the back and face of healthy volunteers to determine the maximum tolerated dose. As expected, the most common side effects were localized, generally mild skin reactions. No serious adverse events were observed. Maximal plasma concentrations of XEN801 were low, whereas skin biopsies from the back of subjects showed a concentration of approximately two orders of magnitude higher than the IC50 and higher than that required for 100% block of SCD1. It is expected that even better penetration will be shown in the facial skin. A Phase 2 dose was selected based on favorable tolerability and skin drug concentrations.
Dr. Pimstone added: “In addition, we continue to advance our Nav1.6 preclinical program, and results from in vivo animal studies in SCN8A epilepsy have been encouraging. Xenon expects to identify a development candidate in 2016 and file an investigational new drug (IND) application in the first half of 2017.”
Xenon’s program to develop a potent and selective inhibitor of the sodium channel Nav1.6 for the treatment of rare childhood epilepsies continues to progress. While Dravet Syndrome primarily results from Nav1.1 loss of function and presumed unopposed neuroexcitatory activity driven by Nav1.6, the company is also interested in other cases of pediatric encephalopathy, such as SCN8A epilepsy, which is caused by gain of function of Nav1.6. Xenon has identified potent, selective Nav1.6 inhibitors, and encouraging results from in vivo animal studies indicate that selective Nav1.6 inhibitors have demonstrated efficacy for seizures in a model of Nav1.6 gain-of-function SCN8A epilepsy. These studies support the hypothesis that SCN8A epilepsies can be treated with potent, selective Nav1.6 inhibitors.
About the XEN801 Phase 2 Clinical Trial
The ongoing XEN801 Phase 2 clinical trial is a randomized, double-blind, multi-center, vehicle-controlled, parallel-group study to determine the safety, tolerability, efficacy and systemic exposure of XEN801 in approximately 150 patients with moderate to severe facial acne. Patients will apply XEN801 (or vehicle placebo) topically to their face for 12 weeks with a 4-week follow up. The primary efficacy endpoint is the percent change in total (inflammatory and non-inflammatory) lesion count from baseline to week 12. Secondary endpoints include the percent change in inflammatory and/or non-inflammatory lesions at different time points throughout the 12-week study as well as a number of Investigator's Global Assessment (IGA) measures. Topline results from the XEN801 Phase 2 clinical trial are expected in the fourth quarter of 2016.
A live audio webcast of today’s presentation will be available on the investors section of Xenon's website at www.xenon-pharma.com and will be available for replay for 90 days following the event.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical-stage biopharmaceutical company discovering and developing a pipeline of differentiated therapeutics for orphan indications that it intends to commercialize on its own and for larger market indications that the company intends to partner with global pharmaceutical companies. Xenon has built a core enabling discovery platform, referred to as Extreme Genetics, for the discovery of validated drug targets by studying rare human diseases with extreme traits, including diseases caused by mutations in ion channels, known as channelopathies. Xenon's Extreme Genetics platform has yielded the first approved gene therapy product in the European Union and a broad development pipeline and multiple pharmaceutical partnerships, including with Teva and Genentech. 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 our ability to achieve milestones in both our proprietary and partnered development programs, the design of a Phase 2 clinical trial of XEN801 and anticipated enrollment, the anticipated timing of IND submissions with regulatory agencies, the initiation of future clinical trials, the timing of and results from our and our collaborators’ ongoing clinical trials and pre-clinical development activities, the potential efficacy, future development plans and commercial potential of our and our collaborators’ product candidates and the progress and potential of ongoing development programs. 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 Extreme Genetics discovery platform or ongoing collaborations 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 pursuant to our collaboration agreements; 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 Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
“Xenon,” the Xenon logo, and “Extreme Genetics” are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.
Investor/Media Contact: Jodi Regts Senior Director, Corporate Affairs Xenon Pharmaceuticals Inc. Phone: 604.484.3353 Email: firstname.lastname@example.org
Source:Xenon Pharmaceuticals Inc.