SK Life Science Presents Cenobamate Research at the 2024 American Epilepsy Society (AES) Annual Meeting

SK Life Science will also host the “Prioritizing Seizure Treatments Through Real-World Patient Case Studies Symposium,” an expert led panel to advance the discussion regarding the unmet need for achieving seizure freedom and the impact of continued seizures on patients’ treatment journeys

PARAMUS, N.J., Nov. 25, 2024 /PRNewswire/ — SK Life Science, Inc., a global leader in treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., will present updated data on cenobamate, an anti-seizure medication, at the 2024 American Epilepsy Society (AES) Annual Meeting in Los Angeles, California, December 6-10, 2024. The company will also host the “Prioritizing Seizure Treatments Through Real-World Patient Case Studies Symposium,” an event led by world-renowned epileptologists.

“The pursuit of seizure freedom is a critical and often elusive goal for epilepsy patients,” said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science. “Our data presentations this year aim to provide healthcare providers with updated strategies and evidence to better address the needs of their patients. Our research will contribute information that highlights cenobamate’s potential as a treatment option covering diverse aspects of cenobamate’s efficacy, safety, and mechanism of action.”

SK Life Science’s Symposium will focus on real-world patient case studies in seizure treatment

and will take place on Friday, December 6, 2024, at 6:00 p.m. PT in the Platinum Ballroom A-C at the JW Marriott Los Angeles L.A. LIVE during the AES Annual Meeting. This session will highlight three key objectives:

Understanding the unmet need for achieving seizure freedom and identifying patients requiring treatment modifications
Recognizing the impact of continued seizures on patients’ treatment journeys
Optimizing treatment regimens for early efficacy, improving the likelihood of seizure freedom, and reducing concomitant medications

The session will feature David Vossler, MD, FAAN, FAES, FACNS, Clinical Professor of Neurology, University of Washington; Danielle Becker, MD, MS, FAES, Division Director of Epilepsy, The Ohio State University Wexner Medical Center; and, Mohammad Koubeissi, MD, FAAN, FANA, FAES, Director, GW Epilepsy Center, The George Washington University. Interested participants attending AES can pre-register at https://scimedregister.com/aes2024.

Poster Presentations

I. Poster Session 1: Saturday, Dec. 7; author presentations from 12 PM – 2 PM

Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Cenobamate in Asian Patients With Focal Seizures (Misra et al)

Poster Number: 1.400

Title: Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Multicenter Study in a Multinational Asian Population (Pradhan et al)

Poster Number: 1.404

Title: Efficacy of Adjunctive Cenobamate by Focal Seizure Subtypes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (Ferrari et al)

Poster Number: 1.405

Title: Cenobamate Maintenance Dose Range Among Patients in the United States: A Retrospective, Real-World Analysis (Wade et al)

Poster Number: 1.436

Title: Clarification of the Mechanism of Action of Cenobamate (Sankar et al)

Poster Number: 1.437

II. Poster Session 2: Sunday, Dec. 8; author presentations from 12 PM – 2 PM

Title: Incidence and Prevalence of Cardiac Arrhythmias with Epilepsy Drugs (Crumb et al)

Poster Number: 2.410

Title: Potential of Cenobamate as a Broad-Spectrum Antiseizure Medication (Melnick et al)

Poster Number: 2.412

Title: The Effect of Cenobamate on Responsive Neurostimulation Epileptiform Events (Aboumatar et al)

Poster Number: 2.415

Title: Wide Range of Cenobamate Doses Associated With Initial Seizure Freedom in Patients With Uncontrolled Focal Seizures: Post-hoc Analysis of a Phase 3, Multicenter, Open-Label Study (Rosenfeld et al)

Poster Number: 2.378

About SK Life Science, Inc. and SK Biopharmaceuticals Co., Ltd.

SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with eight compounds currently in development. Utilizing target-based drug discovery, high-throughput organic screening/high content screening, computer-aided drug design, and combinatorial chemistry, the companies drive R&D efforts in biology/discovery, medicinal chemistry, pharmacology, and clinical development. For more information, visit www.SKLifeScienceInc.com.

SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea’s second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals and digital business. Based in Seoul, SK invests in building sustainable businesses around the world with a shared commitment to reducing global greenhouse gas emissions. SK companies combined have $151 billion in global annual revenue and employ more than 100,000 people worldwide. SK Group is one of TIME’s 100 Most Influential Companies of 2023. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information about SK Inc., visit https://sk-inc.com/en/main/mainpage.aspx. For more information about SK Biopharmaceuticals, visit www.skbp.com/eng.

About XCOPRI^® (cenobamate tablets) CV
Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium current and enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABA_A) ion channel. The precise mechanism by which cenobamate exerts its therapeutic effect is unknown.

Cenobamate is marketed under the brand name XCOPRI^® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals’ partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY^® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland.

Cenobamate is also being developed for commercialization by SK Biopharmaceuticals’ partners in many other countries to meet the needs of patients living with epilepsy, including Dong-A ST Co., Ltd., Eurofarma Laboratórios S.A., Hikma MENA FZE, Ignis Therapeutics, Inc. and ONO Pharmaceutical Co., Ltd.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV

DO NOT TAKE XCOPRI IF YOU:

Are allergic to cenobamate or any of the other ingredients in XCOPRI.
Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.

XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider.

QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.

Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.

DISCONTINUATION:

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

DRUG INTERACTIONS:

XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

PREGNANCY AND LACTATION:

XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use.

Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org.

Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI.

COMMON SIDE EFFECTS:

The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired.

These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

DRUG ABUSE:

XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law.

INDICATION:

XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age.

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

Please see full Prescribing Information.

About Epilepsy

Epilepsy is the fourth most common neurological disorder. There are approximately 3.4 million people living with epilepsy in the United States, with 150,000 new cases each year in the country.^1,2 Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one’s safety, relationships, work, driving, and much more.^3,4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).^3,4 Despite the availability of many antiepileptic therapies, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.⁵

XCOPRI^® and ONTOZRY^® are registered trademarks of SK Biopharmaceuticals Co., Ltd.

References

Epilepsy Foundation. Who Can Get Epilepsy? https://www.epilepsy.com/what-is-epilepsy/understanding-seizures/who-gets-epilepsy. Accessed November 2024.
Epilepsy Foundation. Facts & Statistics About Epilepsy. https://www.epilepsy.com/learn/about-epilepsy-basics/epilepsy-statistics. Accessed November 2024.
Epilepsy Foundation. Staying Safe. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed November 2024.
Epilepsy Foundation. Complications and Risks. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed November 2024.
Chen Z, Brodie MJ, Liew D, Kwan P. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs: a 30-year longitudinal cohort study. https://www.ncbi.nlm.nih.gov/pubmed/29279892. Published online December 26, 2017.