January 11, 2016 – Xenon Pharmaceuticals Inc.
BURNABY, British Columbia, Jan. 11, 2016 (GLOBE NEWSWIRE) — Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today outlined its anticipated key corporate milestones for 2016.
Dr. Simon Pimstone, Xenon’s President and Chief Executive Officer, stated: “Overall, I am very pleased with the advancements made over the past year within both our proprietary and partnered programs. Our pain-focused collaborations with Teva and Genentech continue to progress well as we work to translate the therapeutic potential of the Nav1.7 target into novel pain therapeutics. In our proprietary programs, we met a major 2015 development milestone by initiating and rapidly completing a Phase 1 trial for XEN801, which is now positioned to enter a Phase 2 clinical trial in patients with moderate to severe acne in the first quarter of 2016, with an expected read-out of results in the second half of 2016.”
Dr. Pimstone added: “We enter 2016 in a strong position with the necessary resources to achieve our near-term goals and to advance a novel and diverse product portfolio. We intend to address large therapeutic markets, such as pain, through partnered programs, and pursue rare or orphan diseases, such as rare forms of childhood epilepsy, by further developing proprietary assets within our own pipeline. Additionally, we expect to continue to leverage our Extreme Genetics technology platform to identify novel targets for drug development.”
Anticipated Advancements of Xenon’s Proprietary Pipeline
• XEN801, is a topical stearoyl Co-A desaturase, or SCD1 inhibitor, for the treatment of acne. Xenon’s Phase 1 clinical trial for XEN801 was completed in December 2015 with the data supporting the initiation of a Phase 2 clinical trial in the first quarter of 2016. The aim of this Phase 2 trial is to evaluate the efficacy, safety, tolerability and systemic exposure in approximately 150 patients with moderate-to-severe acne. Xenon anticipates receiving topline results in the second half of 2016.
• Xenon’s development of a Nav1.6 sodium channel inhibitor for the treatment of rare childhood epilepsy disorders – such as Dravet Syndrome, an orphan disease of severe childhood epilepsy – continues to progress, and results from early in vivo studies 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 will continue to leverage its drug discovery platform to identify validated drug targets and develop new product candidates, and expects to provide updates as new drug discovery programs advance in 2016.
Anticipated Milestones in Partnered Programs
• Xenon’s partner Genentech, a member of the Roche Group, is currently conducting two Phase 1 clinical trials for GDC-0276 and GDC-0310, which are both oral, selective Nav1.7 small-molecule inhibitors being developed for the potential treatment of pain. Both Phase 1 clinical trials are ongoing, and pending a full assessment of the results, Genentech intends to initiate a Phase 2 trial in 2016.
• Xenon continues to engage in an active research collaboration with Genentech focused on the discovery of novel pain targets in rare human pain disorders where individuals have either an inability to perceive pain or where individuals have non-precipitated spontaneous severe pain. In September 2015, Xenon announced the successful discovery and identification of a novel pain target, which triggered a milestone payment from Genentech.
• Xenon’s partner Teva Pharmaceutical Industries Ltd. is conducting a randomized, double-blind, placebo-controlled Phase 2b clinical trial for TV-45070 in patients with post-herpetic neuralgia, with results expected in the second half of 2016.
Anticipated Milestones for Commercialized Products
• Xenon is eligible to receive a royalty on commercial sales of Glybera®, which is licensed to uniQure Biopharma B.V. (Nasdaq:QURE), for the treatment of the orphan disorder lipoprotein lipase deficiency. The first patient treated with Glybera as a commercially-available gene therapy was announced by uniQure in November 2015 and enabled by its commercialization partner in the EU, Chiesi Farmaceutici S.p.A.
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 progress and potential of ongoing proprietary and partnered development programs, including those in pain, acne, and epilepsy, the sufficiency of our resources and capabilities to achieve our near-term goals, the timing of IND or IND-equivalent submissions with regulatory agencies, the timing for announcing an additional proprietary drug discovery program, the initiation of future clinical trials, the results of research and development efforts, the timing of and results from ongoing clinical trials and pre-clinical development activities and the future plans of our collaboration partners and their interactions with regulatory agencies. 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 product candidates or those of our collaborators; our Extreme Genetics® discovery platform or ongoing collaborations may not yield additional product candidates and we may not announce our next product drug discovery program within the timelines currently contemplated; 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. 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. Glybera is a registered trademark of uniQure Biopharma B.V. in various jurisdictions.
Jodi Regts, Senior Director, Corporate Affairs
Xenon Pharmaceuticals Inc.