Biohaven Said It Is Presenting Expanded Safety Data From BHV-7000 Multiple-dose Studies At The American Epilepsy Society 2024 Annual Meeting
Biohaven Said It Is Presenting Expanded Safety Data From BHV-7000 Multiple-dose Studies At The American Epilepsy Society 2024 Annual Meeting
biohaven表示將在2024年美國癲癇學會年會上展示BHV-7000多劑量研究的擴展安全數據
- Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation being evaluated in ongoing Phase 2 and 3 clinical studies, demonstrating excellent tolerability at all doses evaluated without central nervous system (CNS) adverse effects typically associated with other anti-seizure medications (ASMs), such as somnolence and cognitive/mood disturbances.
- Qualitative assessment of online social media platforms and forums provided a unique perspective of the unmet needs that people with epilepsy are vocalizing outside of the clinical setting, including the negative impact that ASM associated adverse events have on their quality of life.
- Additional nonclinical data presentations included characterization of BHV-7000 using optical electrophysiology as well as beneficial effects of BHV-7000 on pathogenic developmental epileptic encephalopathy-associated KCNQ2 variants
- 報告了BHV-7000一期多次升高劑量研究的擴展安全性結果，包括正在進行的二期和三期臨床研究中評估的每日一次的緩釋劑型，顯示在所有評估劑量下均具有良好的耐受性，且沒有其他抗癲癇藥物（ASM）通常相關的中樞神經系統（CNS）不良反應，如嗜睡和認知/情緒障礙。
- 對在線社交媒體平台和論壇的定性評估提供了獨特的視角，揭示了癲癇患者在臨床環境之外表達的未滿足需求，包括與ASm相關的副作用對他們生活質量產生的負面影響。
- 額外的非臨床數據演示包括利用光學電生理技術對BHV-7000的特徵進行表徵，以及BHV-7000對病理性發育性癲癇腦病相關的KCNQ2變異體的有益作用。
譯文內容由第三人軟體翻譯。
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