Business
Xenon Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Corporate Update
Progress Reported in Both Proprietary and Partnered Neurology Clinical Programs Additional FDA Feedback Supports Commencement of XEN496 Phase 3 Clinical Trial
About this update from Xenon Pharmaceuticals Inc.
[{"type":"text","content":"Progress Reported in Both Proprietary and Partnered Neurology Clinical Programs \n Additional FDA Feedback Supports Commencement of XEN496 Phase 3 Clinical Trial in 2020 Conference Call at 4:30 pm ET Today BURNABY, British Columbia, May 21, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported its financial results for first quarter ended March 31, 2020 and provided a corporate update. Dr. Simon Pimstone, Xenon’s Chief Executive Officer, said, “Despite the global impacts of the COVID-19 pandemic, I am pleased to report exciting progress in both our proprietary and partnered neurology programs. Over the next 12 months, we anticipate a number of important clinical and regulatory milestone events from our pipeline of innovative epilepsy treatments, and we are fortunate to have the cash runway to support our business objectives.” Dr. Pimstone continued, “Looking specifically at our proprietary epilepsy programs, we anticipate top-line data in the first half of 2021 from the XEN1101 Phase 2b “X-TOLE” clinical trial currently underway in adult focal epilepsy, and we continue to analyze other potential clinical indications for this novel Kv7 potassium channel modulator. Importantly, over the past few months, we have also made great strides in advancing XEN496, which is our proprietary pediatric formulation of ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy. A recently completed pharmacokinetic study testing XEN496 in healthy adult volunteers demonstrates that XEN496 has similar absorption and elimination curves as the historical data for immediate release ezogabine tablets. Building on this encouraging PK data, we have also received recent FDA feedback on our XEN496 program and believe we have all the necessary input to initiate a double-blind, placebo-controlled Phase 3 clinical trial in approximately 40 pediatric patients with KCNQ2-DEE later this year.” Dr. Pimstone added, “I am proud that our partnered programs also continue to advance through development providing opportunities for milestone payments. Our collaborator, Neurocrine Biosciences, expects to file an IND in mid-2020 in order to start a Phase 2 clinical trial for NBI-921352 in SCN8A-DEE pediatric patients. In addition, Flexion Therapeutics recently a...