Longboard Pharmaceuticals Initiates Phase 3 DEEp SEA Study Evaluating Bexicaserin in Dravet Syndrome
Longboard Pharmaceuticals (Nasdaq: LBPH) has initiated its global Phase 3 DEEp SEA Study evaluating bexicaserin for treating seizures associated with Dravet syndrome in patients two years and older. The company has activated the first sites, with additional rapid-start sites expected to be activated in the coming weeks. This study is part of the broader DEEp Program, which includes two trials.
Chad Orevillo, Longboard's Executive VP and Head of Operations, highlighted the company's rapid progression from Phase 2 data to Phase 3 initiation. Mary Anne Meskis, Executive Director of Dravet Syndrome Foundation, praised Longboard's progress, noting recent Rare Pediatric Disease and Orphan Drug designations for their Dravet syndrome treatment. She emphasized the continued unmet need in Dravet syndrome and other rare epileptic conditions.
Longboard Pharmaceuticals (Nasdaq: LBPH) ha avviato il suo studio globale Phase 3 DEEp SEA Study per valutare l'efficacia di bexicaserin nel trattare le crisi associate a Dravet syndrome in pazienti di due anni e oltre. L'azienda ha attivato i primi siti, con ulteriori siti a inizio rapido che si prevede saranno attivati nelle prossime settimane. Questo studio fa parte del più ampio DEEp Program, che comprende due trial.
Chad Orevillo, VP Esecutivo e Capo delle Operazioni di Longboard, ha sottolineato la rapida progressione dell'azienda dai dati della Fase 2 all'inizio della Fase 3. Mary Anne Meskis, Direttore Esecutivo della Dravet Syndrome Foundation, ha elogiato i progressi di Longboard, notando le recenti designazioni per Malattie Pediatriche Rare e Orfani per il loro trattamento della sindrome di Dravet. Ha enfatizzato il continuo bisogno non soddisfatto nella sindrome di Dravet e in altre condizioni epilettiche rare.
Longboard Pharmaceuticals (Nasdaq: LBPH) ha iniciado su estudio global Phase 3 DEEp SEA Study para evaluar el uso de bexicaserin en el tratamiento de las convulsiones asociadas con el Síndrome de Dravet en pacientes de dos años o más. La empresa ha activado los primeros sitios, y se espera que se activen sitios de inicio rápido adicionales en las próximas semanas. Este estudio es parte del programa más amplio DEEp Program, que incluye dos ensayos.
Chad Orevillo, VP Ejecutivo y Jefe de Operaciones de Longboard, destacó la rápida progresión de la empresa de los datos de la Fase 2 al inicio de la Fase 3. Mary Anne Meskis, Directora Ejecutiva de la Fundación Síndrome de Dravet, elogió el progreso de Longboard, señalando las recientes designaciones para Enfermedades Pediátricas Raras y Medicamentos Huérfanos para su tratamiento del síndrome de Dravet. Enfatizó la continua necesidad insatisfecha en el síndrome de Dravet y en otras condiciones epilépticas raras.
롱보드 제약회사(Longboard Pharmaceuticals, Nasdaq: LBPH)는 두 살 이상의 환자에서 드라베 증후군과 관련된 발작 치료를 위한 벡시카세린(bexicaserin)의 효능을 평가하는 세계적인 3상 DEEp SEA 연구를 시작했습니다. 회사는 첫 번째 연구 사이트를 활성화했으며, 추가 빠른 시작 사이트가 몇 주 내에 활성화될 것으로 예상됩니다. 이 연구는 두 개의 시험을 포함하는 더 넓은 DEEp 프로그램의 일환입니다.
롱보드의 총괄부사장 겸 운영 책임자인 채드 오레빌로(Chad Orevillo)는 2상 데이터에서 3상 개시에 이르기까지 회사의 빠른 발전을 강조했습니다. 드라베 증후군 재단(Dravet Syndrome Foundation)의 전무 이사인 메리 앤 메스키스(Mary Anne Meskis)는 롱보드의 발전을 칭찬하며 최근 드라베 증후군 치료에 대한 희귀 소아 질환 및 오르판 약물 지정을 언급했습니다. 그녀는 드라베 증후군 및 기타 희귀 간질 조건에 대한 계속되는 미충족 수요를 강조했습니다.
Longboard Pharmaceuticals (Nasdaq: LBPH) a lancé sa Phase 3 DEEp SEA Study à l'échelle mondiale pour évaluer le bexicaserin dans le traitement des crises associées au Syndrome de Dravet chez les patients âgés de deux ans et plus. L'entreprise a activé les premiers sites, avec d'autres sites de lancement rapide devant être activés dans les prochaines semaines. Cette étude fait partie du programme plus large DEEp Program, qui comprend deux essais.
Chad Orevillo, VP Exécutif et Responsable des Opérations chez Longboard, a souligné la progression rapide de l'entreprise des données de la Phase 2 au début de la Phase 3. Mary Anne Meskis, Directrice Exécutive de la Fondation du Syndrome de Dravet, a salué les progrès de Longboard, notant les récentes désignations pour maladies pédiatriques rares et médicaments orphelins pour leur traitement du syndrome de Dravet. Elle a souligné le besoin toujours non satisfait concernant le syndrome de Dravet et d'autres conditions épileptiques rares.
Longboard Pharmaceuticals (Nasdaq: LBPH) hat seine globale Phase 3 DEEp SEA Studie gestartet, um die Wirksamkeit von Bexicaserin zur Behandlung von Anfällen im Zusammenhang mit Dravet Syndrom bei Patienten ab zwei Jahren zu bewerten. Das Unternehmen hat die ersten Standorte aktiviert, und weitere Standorte mit schnelleren Startmöglichkeiten werden in den kommenden Wochen aktiviert. Diese Studie ist Teil des umfassenderen DEEp Programms, das zwei Studien umfasst.
Chad Orevillo, Executive VP und Leiter der Betriebsabteilung bei Longboard, hob die rasche Entwicklung des Unternehmens vom Phase 2-Daten zum Beginn der Phase 3 hervor. Mary Anne Meskis, Entwicklungsdirektorin der Dravet Syndrom Stiftung, lobte den Fortschritt von Longboard und wies auf die jüngsten Auszeichnungen für seltene pädiatrische Erkrankungen und Arzneimittel für Waisen für ihre Behandlung des Dravet Syndroms hin. Sie betonte das anhaltende unstillbare Bedürfnis im Zusammenhang mit dem Dravet Syndrom und anderen seltenen epileptischen Erkrankungen.
- Initiation of global Phase 3 DEEp SEA Study for bexicaserin in Dravet syndrome
- Rapid progression from Phase 2 to Phase 3 trials
- Received Rare Pediatric Disease and Orphan Drug designations for Dravet syndrome treatment
- None.
Insights
The initiation of Longboard Pharmaceuticals' Phase 3 DEEp SEA Study for bexicaserin in Dravet syndrome is a significant milestone. This study, targeting participants aged two and older, represents a important step in addressing a severe form of epilepsy with treatment options. The rapid progression from Phase 2 to Phase 3 demonstrates strong clinical momentum and efficient drug development.
Key points to consider:
- Dravet syndrome is a rare, drug-resistant epilepsy with high unmet medical need
- Bexicaserin has received Rare Pediatric Disease and Orphan Drug designations, potentially expediting its regulatory pathway
- The global nature of the study suggests a comprehensive approach to data collection
- The DEEp SEA Study is part of a larger DEEp Program, indicating a broader strategy for developmental and epileptic encephalopathies
For investors, this progress signals potential market opportunity in the rare disease space and showcases Longboard's ability to execute on its clinical development plans efficiently. However, Phase 3 studies are costly and outcomes remain uncertain, presenting both opportunity and risk.
- First sites activated with a number of additional rapid-start sites being activated in the coming weeks
“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. “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.”
“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. 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.
About the DEEp SEA Study
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. 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). 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).
ABOUT 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). 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. Longboard recently completed a Phase 1 single-ascending dose (SAD) clinical trial for LP659 in healthy volunteers.
Bexicaserin and LP659 are investigational compounds that are not approved for marketing by the FDA or any other regulatory authority.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. In some cases, you can identify forward-looking statements by words such as “being”, “focus”, “primed for”, “commitment”, “look forward to”, “objective”, “will”, “opportunity”, “working to”, “designed to”, “plan”, or the negative, plural or other tenses of these words, references to future dates or time periods, or other comparable language, and they may include, without limitation, statements about the following: Longboard’s product candidates and programs (including about bexicaserin, FDA designations for bexicaserin, LP659, the DEEp Program and DEEp Sea Study, participating sites and their activation, and participant enrollment), plans, focus and work. For such statements, Longboard claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Longboard’s expectations. Factors that could cause actual results to differ materially from those stated or implied by Longboard’s forward-looking statements include, but are not limited to, the following: the standards for Breakthrough Therapy and other designations are not the same as the standard for drug approval, Breakthrough Therapy designation is based on preliminary clinical evidence, and not all drugs designated as Breakthrough Therapies ultimately will be shown to have substantial improvement over available therapies; the FDA may later decide to rescind a designation if it determines the designation is no longer supported by subsequent data; Longboard’s product candidates are in a lengthy research and development process, the timing, manner and outcome of research, development and regulatory review is uncertain, and Longboard’s product candidates, including bexicaserin and LP659, may not advance in research or development or be approved for marketing; enrolling participants in clinical trials is competitive and challenging; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline or interim data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline or interim data; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Longboard or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; risks related to Longboard’s limited operating history, financial position and need for additional capital; Longboard will need additional managerial and financial resources to advance all of its programs, and you and others may not agree with the manner Longboard allocates its resources; risks related to the development and commercialization of Longboard’s product candidates; risks related to relying on licenses or collaborative arrangements; other risks related to Longboard’s dependence on third parties; competition; product liability or other litigation or disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to regulatory compliance; and risks related to Longboard’s and third parties’ intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Longboard’s forward-looking statements are disclosed in Longboard’s filings with the Securities and Exchange Commission (SEC). These forward-looking statements represent Longboard’s judgment as of the time of this release. Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240926926536/en/
Megan E. Knight
VP, Head of Investor Relations
IR@longboardpharma.com
858.789.9283
Source: Longboard Pharmaceuticals, Inc.
FAQ
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