LA JOLLA, Calif.--(BUSINESS WIRE)--Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that it has initiated its global Phase 3 DEEp SEA Study evaluating its investigational drug bexicaserin for the treatment of seizures associated with Dravet syndrome in participants two years of age and older..

Longboard Pharmaceuticals， Inc.（纳斯达克股票代码：LBPH）是一家临床阶段的生物制药公司，专注于开发治疗神经系统疾病的新型变革性药物，今天宣布已启动其全球 3 期 DEEp SEA 研究，评估其研究药物贝昔卡色林用于治疗两岁及以上参与者与 Dravet 综合征相关的癫痫发作。

“We are thrilled to announce the initiation of our global Phase 3 DEEp Program with our first sites activated and multiple additional sites primed for activation within the next couple of weeks for our DEEp SEA Study in Dravet syndrome. DEEp SEA is the first of two trials within the DEEp Program,” stated Chad Orevillo, Longboard’s Executive Vice President, Head of Operations.

Longboard执行副总裁兼运营负责人Chad Orevillo表示：“我们很高兴宣布启动全球第三阶段深海计划，我们的第一个站点已激活，未来几周内还有多个其他站点将激活，以进行Dravet综合征的深海研究。深海是深海计划中两个试验中的第一个。”。

“I am extremely proud of the team for rapidly progressing from Phase 2 data to Phase 3 initiation further underscoring our commitment to the execution, efficiency and enrollment of our DEEp Program. We look forward to working with the healthcare professionals, patients and families on this important research program.”.

“我为团队从第二阶段数据快速发展到第三阶段启动感到非常骄傲，这进一步强调了我们对DEEp计划的执行，效率和注册的承诺。我们期待着与医疗保健专业人员，患者和家庭合作，共同完成这项重要的研究计划。”。

“I am pleased to see Longboard’s recent progress in Dravet syndrome — first, with Rare Pediatric Disease and Orphan Drug designations, and now with the initiation of the DEEp SEA Study. Longboard’s unique and efficient approach to clinical development in a range of DEEs, including Dravet, is remarkable.

“我很高兴看到Longboard在Dravet综合征方面取得的最新进展，首先是罕见的儿科疾病和孤儿药的命名，现在是深海研究的开始。Longboard在包括Dravet在内的一系列DEE中独特而有效的临床开发方法是非凡的。

A large unmet need still exists not only in Dravet, but in so many other rare epileptic conditions, and I am so happy to see continued advancements in the space,” stated Mary Anne Meskis, Founding Member and Executive Director of Dravet Syndrome Foundation..

Dravet综合征基金会创始成员兼执行董事玛丽·安妮·梅斯基斯（MaryAnneMeskis）表示：“不仅在Dravet，而且在许多其他罕见的癫痫病中，仍然存在大量未满足的需求，我很高兴看到该领域的持续进步。”。。

About the DEEp SEA Study

关于深海研究

The DEEp SEA Study (LP352-302) is a global Phase 3 double-blind, placebo-controlled clinical trial to evaluate the efficacy of bexicaserin in Dravet syndrome as assessed by countable motor seizures in ~160 participants between the ages of two and 65 years old. An important secondary objective is to evaluate the safety and tolerability of bexicaserin.

深海研究（LP352-302）是一项全球3期双盲安慰剂对照临床试验，旨在评估贝西卡塞林在Dravet综合征中的疗效，该试验通过约160名2至65岁参与者的可计数运动性癫痫发作进行评估。一个重要的次要目标是评估贝西卡西林的安全性和耐受性。

Following a 5-week screening period and baseline evaluations, study participants initiate dose titration over a 3-week period and subsequently continue on the highest tolerated dose throughout the maintenance period of 12-weeks. Following the maintenance period, eligible participants will be given the opportunity to enroll in the 52-week DEEp Open-Label Extension (DEEp OLE Study LP352-303).

经过5周的筛查期和基线评估后，研究参与者在3周内开始剂量滴定，随后在12周的维持期内继续使用最高耐受剂量。维护期结束后，符合条件的参与者将有机会参加为期52周的深度开放标签扩展（深度OLE研究LP352-303）。

The Phase 3 DEEp SEA Study is part of the broader DEEp Program which will take place across ~80 sites globally and include ~480 participants with a range of Developmental and Epileptic Encephalopathies (DEEs)..

第三阶段深海研究是更广泛的深海项目的一部分，该项目将在全球约80个地点进行，包括约480名患有一系列发育性和癫痫性脑病（DEE）的参与者。。

ABOUT LONGBOARD PHARMACEUTICALS

关于LONGBOARD PHARMACEUTICALS

Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Longboard’s small molecule product candidates are based on more than 20 years of GPCR research. Bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor subtypes, is being evaluated in a global Phase 3 clinical program (the DEEp Program).

Longboard Pharmaceuticals，Inc.是一家临床阶段的生物制药公司，专注于开发针对神经系统疾病的新型转化药物。Longboard的小分子产品候选产品基于20多年的GPCR研究。Bexicaserin（LP352）是一种口服，中枢作用的5-羟色胺2C（5-HT2C）受体超促性腺激素，对5-HT2B和5-HT2A受体亚型没有观察到影响，正在全球3期临床计划（深度计划）中进行评估。

The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older. Longboard is also evaluating LP659, an oral, centrally acting, sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator, which is in development for the potential treatment of rare neuroinflammatory conditions.

美国食品和药物管理局（FDA）已授予贝西卡塞林突破性治疗方案，用于治疗两岁及以上患者与发育性和癫痫性脑病（DEEs）相关的癫痫发作。Longboard还正在评估LP659，一种口服，中枢作用的1-磷酸鞘氨醇（S1P）受体亚型1和5调节剂，正在开发用于治疗罕见神经炎症的潜在方法。

Longboard recently completed a Phase 1 single-ascending dose (SAD) clinical trial for LP659 in healthy volunteers..

Longboard最近在健康志愿者中完成了LP659的1期单次递增剂量（SAD）临床试验。。

Bexicaserin and LP659 are investigational compounds that are not approved for marketing by the FDA or any other regulatory authority.

贝西卡西林和LP659是未经FDA或任何其他监管机构批准上市的研究性化合物。