Epileptic Encephalopathy, Childhood-Onset

VANCOUVER, British Columbia, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced two new appointments to its Board of Directors: Dr. Gillian M. Cannon and Mr. Justin Gover. Dr. Cannon has more than 30 years of experience in the pharmaceutical industry, where she served in business and commercial leadership roles at Merck and Co., UCB, Otsuka and Roivant. Mr. Gover served as founding Chief Executive Officer and as a director of GW Pharmaceuticals from inception in 1999 until its sale to Jazz Pharmaceuticals for $7.2 billion in May 2021 and brings nearly twenty-five years of experience in leadership positions in the biotechnology industry with a focus on epilepsy. Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “On behalf of our Board of Directors, I am delighted to welcome Gillian and Justin to our Board. Gillian brings a vast knowledge of commercializing novel medicines and leading successful neuroscience franchises at large pharmaceutical companies. In addition to his leadership acumen in the biotechnology industry, Justin brings a depth of understanding of the epilepsy space, with his background as founding CEO at GW Pharma and ongoing advocacy efforts at organizations such as CURE Epilepsy. These Board appointments are particularly timely given our continued efforts in advancing XEN1101 in multiple Phase 3 epilepsy trials and our preparation for commercialization as well as nearing a topline readout of our XEN1101 Phase 2 X-NOVA clinical trial in major depressive disorder. I am proud that both Gillian and Justin are lending their expertise to Xenon and look forward to their valued contributions and counsel.” Gillian M. Cannon, Ph.D. brings more than 30 years of experience in the pharmaceutical industry, where she has served in leadership roles at multiple prominent global pharmaceutical companies including Merck and Co. Inc., UCB Inc. and Otsuka Pharmaceuticals. Serving more than 25 years at Merck, Dr. Cannon held a variety of senior positions, including Global Vice President for Commercial Operations at Merck’s start-up biosimilar business, Merck BioVentures; Business Unit Head for Merck’s specialty products franchise, and Global Commercial Head of Merck’s neuroscience franchise. More recently, Dr. Cannon was the President of North American Operations for UCB Inc. from 2015 to 2017. In 2018, Dr. Cannon joined Roivant Sciences, a biotechnology company, serving initially as COO for Alyvant and subsequently as Head of Commercial Innovation for Roivant. Dr. Cannon currently serves on the Board of Directors for Corcept Therapeutics, a publicly traded clinical-stage biopharmaceutical company; Affibody AB, a Swedish biotechnology company; Edinburgh Innovations, the commercial arm of Edinburgh University; and Our Future Health Trading Board, the largest UK health research program. She also serves as a lecturer in the Drug Discovery Master’s program at Drexel University, PA. Dr. Cannon received her B.Sc. from the University of Edinburgh and Ph.D. in Health Administration from Temple University. Justin Gover brings nearly twenty-five years of experience in leadership positions in the biotechnology industry in the UK and the U.S. Mr. Gover served as founding Chief Executive Officer and as a director of GW Pharmaceuticals plc from the company’s inception in 1999 until its sale to Jazz Pharmaceuticals plc for $7.2 billion in May 2021. Mr. Gover led GW from London, UK from 1999 to 2015, at which time he relocated to San Diego, CA to open the company’s US headquarters. At GW, Mr. Gover led the development and commercialization of Epidiolex® (cannabidiol), which is approved in the U.S. and Europe in the field of childhood onset epilepsy. From 2018 to 2021, Mr. Gover served on the Board of Directors of the Biotechnology Innovation Organization (BIO). Mr. Gover currently serves on the Board of Directors for CURE Epilepsy and Rady Children’s Institute for Genomic Medicine. Mr. Gover holds an M.B.A. from the INSEAD business school in France and a B.Sc. (Hons) from Bristol University, UK. About Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals (NASDAQ:XENE) is 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 . Safe Harbor Statement This 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 our management and directors and their contributions and our prospects; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of our and our partners’ product candidates; our ability to successfully develop and achieve milestones in our XEN1101 and other development programs; our ability to successfully develop and obtain regulatory approval of XEN1101 and our other product candidates; and anticipated enrollment in our clinical trials and the timing thereof. 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; promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; any of our or our collaborators’ product candidates, including XEN1101, 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 impose additional requirements or delay the initiation of clinical trials; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; the impact of pandemics and other health crises on our research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites, collaborators, regulatory agencies and related review times, and contractors who act for or on our behalf; the impact of unstable economic conditions in the general domestic and global economic markets; adverse conditions from geopolitical events; 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” 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: investors@xenon-pharma.com

First patient receives brain-responsive neuromodulation for LGS, a severe and disabling childhood-onset epilepsy MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced that the first patient with Lennox-Gastaut Syndrome (LGS) was treated in its feasibility investigational device exemption (IDE) study. LGS is a devastating form of childhood onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that often lead to injury. The study uses the RNS® System, which has demonstrated safety and effectiveness of brain-responsive stimulation for treating medically intractable focal onset seizures in people 18 and older, to test whether brain-responsive neurostimulation can also be used to treat LGS. The first procedure took place at Emory Healthcare in Atlanta and was performed by Robert E. Gross, MD, PhD, the MBNA Bowman Chair in Neurosurgery and Professor and Vice Chair, Emory University Department of Neurosurgery. “An exciting aspect of this study is that the implant location for each patient is based on customized models of their brain connectivity.” NeuroPace received a $9.3 million National Institutes of Health (NIH) grant through the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN Initiative) to evaluate its responsive neuromodulation technology in those who suffer from LGS. Six study sites will enroll a total of 20 patients 12 years of age and older with LGS and drug-resistant generalized onset seizures. “The NIH looks for ideas that could be transformative, with the potential to change how LGS is treated today,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “In addition to finding the best detection and stimulation settings for responsive neurostimulation in LGS, we are looking to identify changes in the recorded brain data that indicate whether the therapy is effective. These so-called biomarkers may help clinicians treat LGS and also facilitate future research, including the possibility of a larger clinical study into the mechanisms of the disease and treatment approaches.” Presently, antiseizure medications are the standard of care for treatment of LGS. However, even with multiple medications, seizures are rarely controlled, and it is typical for people with LGS to experience increasing disability over their lifetime. "Overall, treatment is rarely effective in LGS, and the outcome remains very poor," said Tracy Dixon-Salazar, PhD, Executive Director of the LGS Foundation and mother of an adult living with LGS. "Those living with LGS need new treatment options for the many seizures, LGS-associated disorders, and treatment side-effects our loved ones suffer. The impact of LGS extends to the whole family, as we shoulder this unpredictable disease and try to manage the many physical, emotional, and financial burdens. We need better treatments now." Disclaimer: Research reported in this press release was supported by the National Institutes of Health’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative under award number UH3NS109557. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About Epilepsy One in 26 Americans will develop epilepsy in their lifetime, with approximately 150,000 new cases of epilepsy diagnosed annually. An estimated 3.4 million Americans currently live with epilepsy. Epilepsy is a chronic disorder, the hallmark of which is recurrent, unprovoked seizures. More people live with epilepsy than autism spectrum disorder, Parkinson’s disease, multiple sclerosis and cerebral palsy – combined.[i] About the RNS® System The RNS® System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA. The closed-loop technology delivers personalized, data-driven treatment targeted to the seizure source by continuously monitoring brain activity, recognizing a patient’s unique seizure pattern, and responding in real-time with imperceptible stimulation to prevent seizures. By recording ongoing EEG data, the RNS System provides physicians with a unique “window to the brain,” enabling them to remotely monitor their patients, gain insights based on brain activity, and use that information to optimize patient care. Long-term clinical studies demonstrate that the RNS System provides significant reduction in seizure frequency and enduring improvements in quality of life and cognition with no stimulation-related side effects. The RNS System is available at most comprehensive epilepsy centers in the United States and is widely covered by insurance. It is currently approved in the United States as an adjunctive therapy for patients 18 years of age and older with drug-resistant focal epilepsy. See important safety information at . About NeuroPace, Inc. Based in Mountain View, Calif., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients suffering from drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders. Forward Looking Statements In addition to background and historical information, this press release contains “forward-looking statements” based on NeuroPace’s current expectations, forecasts and beliefs, including NeuroPace’s expectations and beliefs about future growth and indication expansion, commercialization efforts, expected returns, growth plans and revenue expectations, as well as our assumptions underlying these expectations. These forward-looking statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including the possibility of delays or failures associated with implementation, regulatory actions, failure to maintain or renew key customer and other business relationships, failure to maintain competitive offerings, the possibility of unfavorable results, and other risks associated with our commercialization efforts or business. You should not put undue reliance on these statements or the information presented. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its public filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 10, 2022 and its quarterly report on Form 10-Q filed with the SEC on November 8, 2022, as well as any reports that it may the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace’s views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace. [i]Epilepsy Foundation. “Facts about Seizures and Epilepsy.”

Michael Vi/Shutterstock Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents. Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents. The study will include children and adolescents living with developmental and epileptic encephalopathy, known as epilepsy with myoclonic-atonic seizures (EMAS). In 2018, Epidiolex, developed by GW Pharmaceuticals, became the first cannabis-based drug approved by the FDA and required a reclassification by the U.S. Drug Enforcement Agency prior to commercialization. Epidiolex is derived from cannabidiol (CBD), a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause the typical “high” associated with marijuana, as it does not include tetrahydrocannabinol (THC), the plant’s main psychoactive compound. Epidiolex was approved by the FDA for the treatment of seizures associated with two rare forms of epilepsy: Lennox-Gastaut syndrome (LGS) and Dravet syndrome. Jazz Pharma acquired GW last year for $7.2 billion. Now, Jazz is aiming Epidiolex at EMAS, which is also known as Doose syndrome. EMAS typically begins in early childhood. It is a developmental and epileptic encephalopathy that is fairly uncommon, accounting for 1% to 2% of all childhood-onset epilepsies, according to the Epilepsy Foundation. The disease tends to occur in boys more often than girls and is associated with different types of seizures, including drop seizures, tonic seizures and myoclonic seizures, among others. Jazz noted that seizures in pediatric EMAS patients can be difficult to treat, and some of the children do not respond well to available medications. Currently available treatments for Doose syndrome include the anticonvulsants divalproex sodium, zonisamide, felbamate and others. According to the Epilepsy Foundation, some anticonvulsants can actually worsen the symptoms of EMAS patients. Rob Iannone, executive vice president, global head of research and development of Jazz Pharmaceuticals, pointed out that there are numerous treatment-resistant epilepsy syndromes. Because of that, epileptologists, neurologists who specialize in epilepsy treatment, typically look for efficacy by seizure type, he said. Iannone further noted that most of those types have no syndrome-specific approved treatment. “An EMAS indication would provide support for the use of Epidiolex in a fourth indication of a distinct, generalized seizure type, myoclonic-atonic seizures,” Iannone said in a statement. “Jazz is committed to continuing to generate clinical study data and real-world evidence to further support the utility of the company’s cannabidiol across a broad range of difficult-to-treat seizure types.” The Phase III trial will assess Epidiolex over a 14-week treatment period in a randomized, double-blind, placebo-controlled study. The trial will consist of two parts and enroll pediatric and adolescent patients from the ages of 1 to 18. The first portion of the study will assess the efficacy and safety of cannabidiol compared to placebo as an adjunctive treatment for children and adolescents with myoclonic-atonic seizures. When that portion of the study is completed, the patients will have an option to continue in a 54-week open-label extension trial, Jazz said. Cannabis-based products are being assessed for multiple neurological indications. In addition to Epidiolex, Jazz is also developing Sativex, a cannabis-based drug approved in the United Kingdom for the treatment of multiple sclerosis. However, Sativex failed to reach key endpoints in a Phase III study in June. Other companies are also developing cannabis-based products, including Cara Therapeutics, Corbus Pharmaceuticals and Insys Therapeutics. A recent study published in the Journal of Clinical Psychiatry showed that cannabis-based treatments can significantly reduce anxiety , with cannabidiol reducing anxiety by 50% in young people aged 12-25 who have not responded well to other treatments. Some researchers are also assessing cannabidiol assets against the inflammation associated with COVID-19 infections.