Longboard Pharmaceuticals, Inc.

BOSTON, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Beacon Biosignals, the global leader in at-home EEG and AI-powered brain health analytics, presented two scientific posters at the American Epilepsy Society (AES) Annual Meeting. These posters highlight groundbreaking work resulting from collaborations with both Longboard Pharmaceuticals and UCB, focusing on advancing understanding of sleep disturbances in individuals with Lennox-Gastaut Syndrome (LGS) and their caregivers. Innovative Research in LGS Caregiver Sleep Patterns The first work, created in partnership with Longboard Pharmaceuticals, presents preliminary findings from the Dreem LGS Caregiver Study. This study leverages Beacon's FDA-cleared Dreem 3S™ EEG headband to explore sleep disturbances in caregivers of children with LGS. The results demonstrate that caregivers successfully utilized the at-home EEG device over multi-night recordings, capturing high-quality data without technologist intervention. Findings revealed significant sleep fragmentation among caregivers, likely due to the demands of nocturnal care. The study found a significant increase in Wake After Sleep Onset (WASO) in LGS caregivers of 37.79 minutes vs. 24.70 minutes in controls (p<.05), as well as shortened Sleep Onset Latency of 14.62 minutes vs. 23.43 minutes in controls. These insights provide an essential foundation for understanding the intersection of caregiver burden, stress, and sleep quality in this underserved population. New Insights into Sleep Architecture in LGS The second poster, developed in collaboration with UCB, focuses on the HEADFIRST study, which evaluates sleep architecture in children with LGS compared to neurotypical siblings. Using the Dreem 3S EEG headband*, this study identified marked disturbances in sleep patterns among LGS participants, including increased wakefulness during sleep periods (WASO) and fewer sleep cycles (mean of 4.6 in LGS participants vs. 2.6 cycles in neurotypical controls, p<0.05). Critically, LGS participants also exhibited a significant reduction in REM sleep (56.77 minutes, vs. 104.34 minutes in controls, p<0.05), a finding consistent with the neurological underpinnings of the syndrome. HEADFIRST is a basket study that aims to assess the Dreem 3S headband's usability in tracking sleep and brain activity in both pediatric patients with neurodevelopmental disorders and in neurotypical controls, enrolling up to 300 participants across multiple disorders. The first phase of the study, in partnership with the Lennox-Gastaut Syndrome (LGS) Foundation, focuses on usability, reliability, and clinical utility of using Dreem for a pediatric cohort with LGS. These are the first results from the HEADFIRST study after only starting in mid-September 2024, and these findings underscore the importance of longitudinal sleep data in understanding LGS-related sleep pathology and its implications for treatment. "Our AES presentations this year demonstrate the transformative potential of Beacon's technology in advancing neurodiagnostics," said David Matthews, PhD, Chief Business Officer of Beacon Biosignals. "By collaborating with industry leaders like UCB and Longboard, we are uncovering critical insights into epilepsy-related sleep disorders, supporting the development of novel therapies, and ultimately improving outcomes for patients and their families." Feasibility of At-Home EEG in Clinical Trials Beacon will take the results from these two studies forward to assess the extent to which the Dreem 3S overcomes the challenges posed by traditional wired EEG systems, which can be intrusive and disruptive for patients and their caregivers while limiting longitudinal data collection. The Dreem 3S headband, equipped with six dry-EEG electrodes and an accelerometer for head movement and body position monitoring, collects clinical-grade EEG data in the comfort of the patient's home. The device's AI-driven sleep staging capabilities have already been validated to perform equivalent to or better than human experts. The FDA's recent authorization of Beacon's Dreem 3S as the first wearable with a Predetermined Change Control Plan (PCCP) ensures the ongoing enhancement of these capabilities and reinforces Beacon's leadership in clinical-grade EEG acquisition, analytics, and sleep research. About Beacon Biosignals Beacon Biosignals is a health technology company transforming the development of treatments for neurological, psychiatric, and sleep disorders. Leveraging advanced machine learning, wearable EEG devices, and large real-world neurophysiology datasets, Beacon accelerates insights into brain activity to improve patient outcomes. For more information, visit https://beacon.bio. * Device is used as research use only in pediatric populations. Media contact:Dan FloreyInfo@beacon.bio

PALM BEACH GARDENS, Fla., Dec. 9, 2024 /PRNewswire/ -- Forward Therapeutics, Inc., a pioneering biopharmaceutical company committed to transforming the treatment of chronic inflammatory disorders, today announced the appointment of Vincent Aurentz to its board of directors. Mr. Aurentz brings extensive strategic expertise and business leadership, developed over more than 35 years in the biopharmaceutical industry. Notably, he served as Executive Vice President (EVP) and Chief Business Officer (CBO) at Arena Pharmaceuticals, where he played a pivotal role in shaping corporate strategy and business development. His leadership efforts culminated in Arena's acquisition by Pfizer for $6.7 billion. Mr. Aurentz also played a significant role in the formation of Arena's spinout, Longboard Therapeutics, which was recently acquired by Lundbeck for approximately $2.6 billion. He served on Longboard's board, further contributing to its strategic growth and success. "We are thrilled to welcome Vince to our board", commented Toufike Kanouni, Forward's CEO and co-founder. "Vince's extensive experience in corporate strategy and business development, coupled with his proven track record of driving growth and creating value, will be instrumental as Forward continues to advance its pipeline of next-generation immune therapies." Looking forward to his new role, Vince remarked, "I am excited to join Forward Therapeutics at such a pivotal moment. Their innovative platform has built a portfolio of oral immunomodulators creating the potential for a wave of best-in-class therapies. This could bring important improvement and much-needed alternatives to existing therapies to provide options to the entire spectrum of patients with immune-mediated disorders." About Vincent Aurentz Vincent E. Aurentz brings decades of experience in the biopharmaceutical sector, having held key leadership positions across industry-leading organizations. He serves on the board of several companies including Longboard Pharmaceuticals, Inc. and CorHepta Pharmaceuticals, Inc. Prior to his role as EVP and CBO at Arena Pharmaceuticals, he served in executive and board positions in multiple biotech companies. Vince also held an executive board role at Merck KGaA/Merck Serono and held senior executive leadership roles at Quintiles, CSC Healthcare, and Andersen Consulting as wel as co-founded a venture capital and advisory firm. He holds a B.S. in Mathematics and was the Medallion Award winner for outstanding achievement in Mathematics from Villanova University. About Forward Therapeutics Forward Therapeutics, Inc. is a next-generation biopharmaceutical company focused on transforming the treatment of chronic inflammatory disorders through its pipeline of novel small-molecule immune therapies. In late 2023, Forward raised $50 million in Series A funding from leading healthcare investors, including BVF, RA Capital, and OrbiMed. For more information, visit and follow us on LinkedIn. Contact Toufike Kanouni CEO and Co-founder Forward Therapeutics, Inc. (561) 232-2641 [email protected] SOURCE Forward Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

尽管多家big pharma多少也有重磅产品，但说到CNS领域内最为响亮的玩家，无疑当属来自丹麦的灵北制药（Lundbeck）。这家公司的产品也是国内外众多企业纷纷仿制的对象。 2023年，灵北制药销售额199亿丹麦克朗（汇率基本等同于人民币），按固定汇率计算，同比增长8%。预计2024年销售额增长将保持7%-10%，但实际情况可能更好。就2024年前三季度而言，灵北的收入达到近165亿丹麦克朗，按固定汇率计算同比增长13%。 其中74%收入来自于四大战略品牌，包括Rexulti布瑞哌唑、Brintellix/Trintellix伏硫西汀、Abilify LAI franchise阿立哌唑长效注射剂系列，以及新产品治疗偏头痛的抗CGRP单抗Vyepti（eptinezumab），前三季度收入达到同比增长21%，尤其是最为重要的美国市场表现强劲；此外，还有老产品Cipralex/Lexapro艾司西酞普兰贡献10%收入，其最大市场是中国，不过全球市场由于受到仿制药全面冲击，已经难以实现增长，目前只能勉维持；至于其他成熟产品已经处于衰败状态，不再单列了。 接下来重点介绍下上述四大战略品牌产品。 首当其冲的便是Rexulti布瑞哌唑。 2024年前三季度为灵北贡献收入38.06亿丹麦克朗，占总体收入的23%，同比增长16%。美国是最大市场，且需求保持增长，其他主要市场包括巴西和加拿大。 布瑞哌唑由日本大冢原研，后由大冢和灵北联合开发，为第三代抗精神病药物，是血清素受体5-HT1A和多巴胺受体D2和D3的部分激动剂，同时还是血清素受体5-HT2A和5-HT2B，以及肾上腺素受体α-1和α-2的部分拮抗剂。布瑞哌唑对这些受体均表现出高亲和力。 2015年，布瑞哌唑率先被美国FDA批准作为重度抑郁辅助疗法，以及治疗精神分裂症。2023年5月又被美国FDA批准用于治疗阿尔茨海默病痴呆相关激越症状（AADAD）。即便阿尔茨海默病药物研发红红火火，但目前只能延缓疾病进展；因此，缓解相关症状，改善生活质量显得尤为重要。 激越是阿尔茨海默病痴呆患者的典型症状之一，约半数阿尔茨海默病患者会出现激越症状。布瑞哌唑获批用于这一病症也是打开了一个巨大市场，自从2023年4月在美国获批以来，该适应症的处方量增长361%，而同时期其他适应症的处方量增长只有15%。 此外，美国FDA在2024年4月还受理了布瑞哌唑联合舍曲林治疗PTSD（创伤后应激障碍）的上市申请，这又是一个大适应症。 面对这样一个大品种，显然是难逃仿制药公司的目标，包括中国药企。2024年6月，布瑞哌唑片在国内获批用于精神分裂症。令人瞠目结舌的事情是，就在获批进口短短不到半年时间里，已经有多达20家提交仿制药上市申请，甚至包括多家申请口崩片和口溶膜等新剂型的上市申请。 出现这样的情况，有三点原因。 一是说明这绝对是一个好产品，而且是非常好的仿制对象，化合物专利即将于2026年到期，国内企业早早就盯上这块肥肉。只待原研批准，就立马提交上市申请，只需BE研究即可，无需3期临床，节约时间和费用；二是国内仿制药是多么内卷，前期都做好了充分工作，立项调研已经没有信息差，全部研发生产工作全部踩准时间点，对于好品种，开展各项工作毫不含糊；三是从侧面反映了对中国市场似乎有点力不从心，虽然灵北也将中国视为关键市场，但在美国FDA批准9年之久才来到中国，可谓姗姗来迟。如此一来，布瑞哌唑在国内的仿制药审评周期与化合物专利到期时间基本吻合，留给原研产品的市场窗口期或许只有短短两年时间，就将直面仿制药竞争。 第二款产品Brintellix/Trintellix伏硫西汀。 这是由灵北原研，又与另一家日本药企武田合作开发的抗抑郁药，能增强中枢神经系统内神经递质5-羟色胺的作用，而5-羟色胺与焦虑情绪调节相关，提高该神经递质水平有助于缓解焦虑症状。 2024年前三季度销售额35.76亿丹麦克朗，同比增长14%，均略逊色于布瑞哌唑。贡献主要来自美国、西班牙、意大利和日本。 这款产品于2017年在中国批准进口，2022年10月化合物专利到期。不过从2021年起就先后有10余家仿制药批准上市。但其晶型的专利保护期还将持续至2027年。有国内企业已经发起了专利无效的挑战，有部分晶型挑战成功，可以绕开原研专利；而其余产品仍在灵北的专利期内。总体而言，原研在国内市场自由发挥的时间并不长。 第三个产品阿立哌唑，可以说是药品生命周期管理的典型案例，从多种口服剂型，到如今的注射剂甚至是长效注射剂，花样繁多，不仅是通过剂型改良延长生命周期，也确实在解决临床应用的难点，提高患者依从性。 尤其在原先阿立哌唑一个月长效注射剂Abilify Maintena® 400mg的基础上，大规格Abilify Asimtufii和Abilify Maintena® 960 mg也在2023年4月和2024年3月分别被FDA和EMA批准，用于双相I型障碍和精神分裂症的维持治疗，为系列产品注入新的活力，专利期将延续到2033年。2024年前三季度，阿立哌唑长效注射剂系列销售额26.18亿丹麦克朗，同比增长10%。 以上三个品种都是小分子药物，也在不同程度上面临着仿制药的挑战。 第四个战略品种是Vyepti，一款预防偏头痛的CGRP单抗eptinezumab，是首个全长兔源单抗药物，也是灵北的第一个单抗产品。2020年2月被美国FDA批准。 2024年前三季度销售额21.16亿丹麦克朗，同比增长76%，即将追上身前的阿立哌唑长效注射剂系列。相比其他战略产品的专利情况，Vyepti的专利期还有13年之久。 或许是深刻体会到中国仿制药的实力，加上Vyepti是灵北实践扩展适应症的战略举措的重要产物之一，灵北通过各种方式加快Vyepti进入中国的步伐。 2023年已经通过医疗试点在海南瑞金医院批准使用，紧接着在2024年又在大湾区推广。与此同时，针对亚洲人群的关键临床SUNRISE也在稳步推进中，预计在2025年底在中日韩提交上市申请。 尽管现有的Vyepti只需每年静脉给药4次30min，但还是远不能满足临床需求。研究表明40%到70%的偏头痛患者无法从靶向CGRP药物得到充分获益。鉴于此，灵北还在研究不同的信号通路和作用机制，并得到抗PACAP药物Lu AG09222，正处于2b期临床试验（PROCEED）评估皮下给药疗效。计划2026年启动3期临床试验，预计在2029年获批。同时也在研究CGRP-PACAP联用，双管齐下预防偏头痛。 显然，灵北制药重点研究偏头痛的神经学机制及相关药物，已经超出了原先专注的CNS四大方向，包括抑郁、精神分裂、阿尔茨海默病以及帕金森病。这样的转变，其实源于灵北的适应症战略扩展。 如今的灵北已经不局限于传统的4大方向，下定决心开始全面发力，更加注重研究生物学本质，包括1）神经元回路和神经元生物学；2）‌蛋白质聚集、折叠和清除机制；3）‌神经肽信号；以及，4）神经系统炎症和神经免疫学，从而将适应症领域扩展到其他神经精神疾病。 之所以做出这样的战略布局，源于灵北观察到神经学已经处于科学突破的前沿，从技术、医学到药政监管的进步，无一不在推动新疗法创新。新的药物分子形式（new drug modalities）正在增加治疗机会，新的生物标记物（new biomarkers）正在创造早期诊疗的机会，而监管革新也在加速神经类药物的批准进程，在欧美已经位列前三。 除了前面提到的偏头痛系列管线之外，灵北扩展研发的适应症领域还有多种。 近期一则大新闻是灵北制药在2024年10月宣布以26亿美元收购Longboard，从而获得完成2期临床试验的高度选择性5HT2c激动剂bexicaserin，此前被FDA授予突破性疗法资格。 即便现在已经有多款抗癫痫药物，但是仍然有25%到40%癫痫患者有耐药性癫痫发作。在美国，发育性癫痫性脑病（Developmental and epileptic encephalopathies，DDE）患者有22万人，其中有药可治的4种疾病覆盖12万患者，而无药可治的则还有10万人。2期临床试验显示，bexicaserin对多种DEE都表现出治疗潜力。 2024年第四季度，bexicaserin启动3期临床试验，计划在2028年第四季度上市。灵北预测销售峰值为15到20亿美元。 针对帕金森，公司还在研发一款创新性口服前药Lu AF28996，其活性代谢产物对多巴胺D1和D2受体具有激动特性，激活直接和间接通路。PK性质不同于左旋多巴和其他短效多巴胺激动剂，代谢产物来回转化，类似储库达到药物持续暴露的效果，从而可以保持长时间“开”的状态。 另一种疾病是和帕金森类似的多系统萎缩（multiple system atrophy，MSA），这是一种成年期发病、散发性的神经系统变性疾病，临床表现为帕金森病样症状、自主神经功能紊乱，患者人群26000人。 丹麦公司Lundbeck Inc和Genmab AS合作开发了一款靶向α-突触核蛋白C端的人源化单克隆IgG1抗体Amlenetug（Lu AF82422），获得了EMA的孤儿药资格。2期临床试验显示临床进展延缓27%。 公司计划在2025年第一季度启动3期临床试验计划，预计2029年获批上市，销售峰值15到30亿美元。 此外，灵北还有两款早期临床资产，包括Lu AG13909是抗ACTH单抗用于神经激素功能失调，包括先天性肾上腺皮质增生症（CAH）和库欣病（CD）；以及，Lu AG22515是CD40L阻断剂，目前正在进行针对甲状腺眼病的概念验证研究。 上述这么多品种，又有多少会被仿制呢？灵北唯有不断超越自我，才成就了CNS领域的王者地位。 其实，灵北也不是全部都是自己独立完成的。相反，现有的研发管线有70%来自外部，通过战略收购补充内部创新，利用外部资源将先进技术、生物学发现和候选药物整合起来从而建立起成功的研发管线。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。 免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。