Longboard Pharmaceuticals Launches Phase 3 Study for Bexicaserin
Longboard Pharmaceuticals Initiates Phase 3 DEEp SEA Study
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company committed to pioneering transformative medications for neurological disorders, has recently taken a significant step forward. The company has officially launched its global Phase 3 DEEp SEA Study, which examines the investigational drug bexicaserin's effectiveness in treating seizures linked to Dravet syndrome in patients aged two years and older.
Excitement Around the DEEp SEA Study Launch
In a statement, Chad Orevillo, Longboard’s Executive Vice President and Head of Operations, expressed enthusiasm about kicking off the Phase 3 DEEp Program. He highlighted the rapid progress made from the previous Phase 2 trials to this new initiative, showcasing the company's dedication to efficiency and enrollment in the DEEp Program. The activation of the initial study sites, along with several more expected to follow suit soon, demonstrates Longboard's proactive approach in this vital research initiative.
Insights from Experts
Mary Anne Meskis, a Founding Member and Executive Director of the Dravet Syndrome Foundation, commended Longboard's advancements in the realm of Dravet syndrome. She noted the acquisition of Rare Pediatric Disease and Orphan Drug designations prior to this study's initiation. Her reflections emphasized the remarkable and efficient clinical development strategy Longboard has adopted, which is crucial given the pressing unmet medical needs in Dravet and other rare epileptic conditions.
Understanding the DEEp SEA Study Design
The DEEp SEA Study (also referred to as LP352-302) is structured as a global, double-blind, placebo-controlled clinical trial. This comprehensive study will assess bexicaserin's efficacy as measured by the frequency of motor seizures in approximately 160 participants between the ages of two and 65. Aside from the primary efficacy objectives, the study also aims to evaluate the safety and tolerability of bexicaserin.
Participants will engage in a five-week screening period accompanied by baseline evaluations, followed by a three-week dose titration phase. During this phase, participants will gradually increase their dosages until they find the highest level they can tolerate. Subsequently, they will continue on this optimized dose for a maintenance period lasting 12 weeks. After this maintenance phase, participants meeting eligibility criteria will have the option to join the 52-week DEEp Open-Label Extension Study (DEEp OLE Study LP352-303).
Longboard Pharmaceuticals: A Leader in Neurological Treatments
Longboard Pharmaceuticals, Inc. is at the forefront of biopharmaceutical research, with a focus on developing innovative, transformative treatments for various neurological disorders. The company’s small molecule drug candidates rest on over two decades of GPCR research, a crucial factor in designing efficacious treatments. Bexicaserin, known scientifically as LP352, is highlighted as a centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, which does not negatively impact the 5-HT2B and 5-HT2A receptor subtypes. This makes it a promising candidate within the DEEp clinical program.
Future Directions and Innovative Trials
The U.S. FDA has recognized the potential value of bexicaserin for treating seizures associated with Developmental and Epileptic Encephalopathies (DEEs) in patients aged two years and older by granting it Breakthrough Therapy designation. Furthermore, Longboard is investigating another promising compound, LP659, which modulates sphingosine-1-phosphate receptor subtypes 1 and 5, targeting rare neuroinflammatory conditions. Noteworthy is Longboard’s successful completion of a Phase 1 single-ascending dose clinical trial for LP659 involving healthy participants.
It’s essential to note that both bexicaserin and LP659 remain investigational compounds and have not yet received market approval from the FDA or other regulatory bodies.
Frequently Asked Questions
What is the DEEp SEA Study?
The DEEp SEA Study is a global Phase 3 clinical trial evaluating the efficacy of bexicaserin in treating seizures linked to Dravet syndrome.
How many participants are involved in the DEEp SEA Study?
Approximately 160 participants aged between two and 65 will participate in the study.
What are the main objectives of the DEEp SEA Study?
The primary objective is to assess the efficacy of bexicaserin, while secondary objectives focus on its safety and tolerability.
What is Longboard Pharmaceuticals' focus?
Longboard Pharmaceuticals focuses on developing innovative treatments for neurological disorders, including rare epileptic conditions.
Are bexicaserin and LP659 approved medications?
No, both bexicaserin and LP659 are investigational compounds and are not yet approved for marketing.
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