BURNABY, British Columbia, March 31, 2020 (GLOBE NEWSWIRE) — Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today provided a corporate update in the context of the developing situation with the COVID-19 pandemic.
Dr. Simon Pimstone, Xenon’s Chief Executive Officer, said, “The safety of Xenon’s employees and their families, as well as the healthcare professionals and patients involved in our clinical studies, is of the utmost importance to us. As we face an unprecedented health system crisis globally, we are focused on doing all we can at Xenon internally, in collaboration with our partners, and in our community to support the collective global public health initiatives to address the COVID-19 pandemic. Earlier this month, we implemented ‘work-from-home’ measures, suspended all non-critical lab work, and ceased non-essential business travel. Within the community in British Columbia, Xenon is in active discussions to assist in building COVID-19 screening capacity and has spearheaded a local initiative to collect Personal Protective Equipment from non-hospital-based research laboratories and collate an inventory of lab equipment useful in COVID-19 testing. Xenon will continue to live by our mission, to put people first, and will continue to do whatever we can, to protect the health and well-being of our staff, their families, and our community.”Dr. Pimstone stated, “Given the rapidly changing environment, we are providing a corporate update on our proprietary and partnered programs. At a high level, it’s important to state that Xenon is in a very sound financial position. We have the benefit of a strong balance sheet and the resources to continue our work during this global public health crisis. Our cash, cash equivalents and marketable securities were approximately $235 million at the end of February 2020, which we anticipate provides us with sufficient cash to fund operations into 2022. We continue to make prudent business and spending decisions, with the flexibility to extend cash runway further if required, and are confident we have the necessary resources to manage through these unprecedented times.”Dr. Pimstone continued, “Within our XEN1101 ‘X-TOLE’ Phase 2b clinical trial, as with other trials ongoing in our industry, we are seeing a significant reduction in new patient enrollment for numerous reasons related to the COVID-19 pandemic; therefore, we have adjusted guidance with topline data now anticipated in the first half of 2021, which is, of course, dependent upon the rate of patient enrollment throughout the remainder of this year. Despite this shift in guidance, we are pleased with our progress in the X-TOLE study to date. We are particularly encouraged by our review of safety data on a blinded basis, which suggests that XEN1101 is currently being well tolerated. The rate of discontinuations to date in the study is lower than modeled. Of note, to date, more than 90% of subjects from the double-blind portion of the trial have entered the open-label extension phase. Based on this review of blinded safety data to date, we believe tolerability is well within the modeled parameters, and, therefore, we do not believe an interim analysis is required. Our goal is to complete the study, as planned, in the shortest possible time frame.Dr. Pimstone added, “We are also pleased to report that we recently completed a pharmacokinetic, or PK, study testing XEN496, our proprietary pediatric formulation of ezogabine, in healthy adult volunteers. The PK profile observed for XEN496 appears to be comparable to historical PK data for immediate-release ezogabine tablets, with XEN496 showing similar absorption and elimination curves, and we are excited that these data support Xenon’s planned Phase 3 clinical trial of XEN496 in patients with KCNQ2-DEE. We recently received Fast Track designation for XEN496 from the FDA, and we look forward to receiving FDA feedback on our Phase 3 protocol, which we anticipate receiving in the second quarter. In addition, our partnered programs remain on track with no changes to our previous guidance.”Proprietary Programs XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. Designed as a randomized, double-blind, placebo-controlled, multicenter study, a Phase 2b clinical trial (called the X-TOLE study) is underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. In order to alleviate pressures on physicians and healthcare workers and to continue to protect patient safety in the midst of the COVID-19 pandemic, Xenon’s primary efforts are focused on patients currently enrolled in the study, either in the double-blind portion or in the open-label extension portion of the study, while making other necessary amendments in the study, including minimizing any in-person patient visits and making provisions for adequate drug supplies to patients wherever possible. Importantly, there is no anticipated impact to the data integrity of the study’s efficacy endpoints since measurements are captured in a patient-reported, electronic seizure diary, which also provides the benefit of allowing sites and Xenon to monitor each patient in the trial in real-time remotely. Xenon is in close collaboration with each of its clinical sites in North America and Europe, taking specific direction from their respective clinical guidelines as they relate to new patient screening and randomization. The vast majority of clinical sites are not screening or randomizing any new patients, and Xenon is supportive of the prudent steps these clinical sites are taking that are focused on protecting patient safety as a first priority.
For the patients who have been enrolled and treated to date in the X-TOLE trial, Xenon can review blinded data to assess safety, tolerability and discontinuations. To date, XEN1101 has been well-tolerated and the rate of discontinuations from the study are below what had been modeled. In addition, to date, more than 90% of subjects from the double-blind portion of the trial have rolled-over into the open-label extension phase. Therefore, based on analysis of the blinded safety data to date, Xenon does not expect to conduct an interim analysis, which was an option that would have allowed for re-sizing of lower dose groups or for other changes to the study if tolerability was different than modeled. Xenon is exploring the expansion of the X-TOLE clinical trial to include new sites in both existing and new jurisdictions to support enhanced patient screening as soon as the clinical trial sites deem it safe to do so. Xenon is adjusting its guidance for topline data, which was previously expected in the second half of 2020 and is now anticipated in the first half of 2021, dependent upon feedback from the clinical sites and patient enrollment rates. Xenon also continues to explore the development of XEN1101 in other neurological indications.XEN496 (active ingredient ezogabine) is a Kv7 potassium channel modulator being developed by Xenon. The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation for the investigation of XEN496 for the treatment of seizures related to KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). The FDA has also indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496’s efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. Xenon recently completed a pharmacokinetic (PK) study testing its proprietary pediatric formulation of ezogabine (XEN496) in 24 healthy adult volunteers. Subjects were given a single 400 mg dose of XEN496 in either fed or fasted states. While the study was not designed to determine bioequivalence given ezogabine is not available to use as a comparator, the PK profile observed for XEN496 appears to be comparable to historical PK data for immediate-release ezogabine tablets, with XEN496 showing similar absorption and elimination curves, which supports Xenon’s planned Phase 3 clinical trial of XEN496 in patients with KCNQ2-DEE. The full PK data will be submitted to the FDA once the final study report is available. Feedback from the FDA regarding the Phase 3 clinical trial design is expected in the second quarter of 2020, and the Phase 3 clinical trial in KCNQ2-DEE is anticipated to start in 2020, dependent upon the ability to initiate clinical sites and patient enrollment given the ongoing COVID-19 pandemic.
XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study is examining the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy. Results from this Phase 2 study are expected in 2020, dependent upon patient enrollment rates given the ongoing COVID-19 pandemic. Depending on the final results from the study, CAE may represent a potential orphan indication for future development of XEN007.Partnered ProgramsNBI-921352: Xenon has an ongoing collaboration with Neurocrine Biosciences, Inc. to develop treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor for epilepsy. There is currently no change to previous guidance. Neurocrine Biosciences anticipates filing an IND application with the FDA in mid-2020 in order to start a Phase 2 clinical trial in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon’s 30-day trailing volume weighted average price at that time.
FX301: Flexion Therapeutics, Inc. has acquired the global rights to develop and commercialize FX301 (formerly XEN402), a Nav1.7 inhibitor. Flexion’s pre-clinical FX301 program consists of XEN402 formulated for extended release from a thermosensitive hydrogel. There is currently no change to previous guidance. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion has indicated that it anticipates initiating FX301 clinical trials in 2021.Financial and Operational GuidanceAs reported on March 9, 2020, cash and cash equivalents and marketable securities as of December 31, 2019 were $141.4 million, compared to $119.3 million as of December 31, 2018. Subsequent to December 31, 2019, Xenon raised additional net proceeds of approximately $102.8 million, net of underwriting discounts and commissions, but before offering expenses, under its November 2019 ATM equity offering and an underwritten public offering. Based on current assumptions, which include fully supporting the planned clinical development of XEN1101, XEN496 and XEN007, Xenon anticipates having sufficient cash to fund operations into 2022, excluding any revenue generated from existing partnerships or potential new partnering arrangements.Xenon’s estimated balance as of February 29, 2020 of approximately $235 million of cash, cash equivalents and marketable securities is a preliminary estimate based on management’s analysis, is subject to further internal review, and has not been reviewed or audited by Xenon’s external auditors.About Xenon Pharmaceuticals Inc.We are a clinical stage biopharmaceutical company committed to developing innovative therapeutics to improve the lives of patients with neurological disorders. 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 StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations; our estimated balance of cash, cash equivalents and marketable securities as of February 29, 2020; the timing of and results from clinical trials and pre-clinical development activities, including those related to XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered product candidates; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of XEN496, XEN1101, XEN007 and other proprietary and partnered product candidates; the anticipated timing of IND, or IND equivalent, submissions and the initiation of future clinical trials for XEN496, XEN1101, XEN007, and other proprietary products, and those related to NBI-921352, FX-301, and other partnered candidates; the efficacy of our clinical trial designs; our ability to successfully develop and achieve milestones in the XEN496, XEN1101, XEN007 and other proprietary development programs; the timing and 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 and the timing thereof; the progress and potential of our other ongoing development programs; the potential receipt of milestone payments and royalties from our collaborators; our expectation of having sufficient cash to fund operations into 2022; 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: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations may be more severe and more prolonged than currently anticipated; 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, may impose additional requirements or delay the initiation of clinical trials; regulatory agencies may be delayed in reviewing, commenting on or approving any of our or our collaborators’ clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; 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. Our preliminary estimate of the balance of our cash, cash equivalents and marketable securities as of February 29, 2020 is the responsibility of management, is subject to management’s review and the final balance could differ from management’s preliminary estimate. This preliminary estimate has not been reviewed or audited by Xenon’s independent registered public accounting firm and no assurance is given by such independent registered public accounting firm on such preliminary estimate. 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” and the Xenon logo 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
Xenon Pharmaceuticals Inc.
Phone: 604.484.3353
Email: [email protected]
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