Xenon Initiates Phase 2 Clinical Trial of XEN801 to Treat Moderate to Severe Acne
BURNABY, British Columbia, Feb. 10, 2016 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced that it has commenced dosing patients in a Phase 2 clinical trial of XEN801, which is a stearoyl Co-A desaturase-1, or SCD1, inhibitor being developed for the treatment of moderate to severe acne.
The Phase 2 clinical trial is a randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the efficacy, safety, tolerability and systemic exposure of XEN801 for the treatment of moderate to severe facial acne. Xenon expects to enroll approximately 150 patients with acne at multiple sites, with topline results expected in the fourth quarter of 2016.
Dr. Simon Pimstone, Xenon's President and Chief Executive Officer, commented: “We have met a key corporate milestone as our most advanced proprietary product, XEN801, has now progressed into a Phase 2 trial based on the results from our completed Phase 1 clinical trial. By targeting a reduction in the size and number of sebaceous glands, thereby reducing sebum production, we believe XEN801 is a promising, novel treatment for acne, which we anticipate could be better tolerated and without the serious side effects that often limit the use of currently approved retinoid treatments.”
In the Phase 1 study, XEN801 was found to be safe and generally well tolerated. In total, 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 the median skin concentration of XEN801 was above the drug concentration predicted for efficacy for all dose volumes evaluated. A Phase 2 dose was selected based on favorable tolerability and skin drug concentrations.
About the XEN801 Phase 2 Clinical Trial
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 the design of a Phase 2 clinical trial of XEN801 and anticipated enrollment, the anticipated timing of topline results in the fourth quarter of 2016, the potential efficacy, future development plans and commercial potential of our product candidates, including XEN801, 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; 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.
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Investor/Media Contact: Jodi Regts Senior Director, Corporate Affairs Xenon Pharmaceuticals Inc. Phone: 604.484.3353 Email: email@example.com