In La Jolla, California, Longboard Pharmaceuticals, Inc. (NASDAQ: LBPH) has initiated a global Phase 3 clinical trial for bexicaserin, an investigational drug targeting seizures related to Dravet syndrome in patients aged two years and older. The trial, named the DEEp SEA Study, has already activated its first sites, with plans to activate more in the upcoming weeks.
The DEEp SEA Study is a double-blind, placebo-controlled trial designed to evaluate the efficacy of bexicaserin by monitoring motor seizures in around 160 participants aged two to 65 years. The study will also assess the safety and tolerability of the drug. Participants will go through a 5-week screening period, followed by a 3-week dose titration period, and then a 12-week maintenance period on the highest tolerated dose. Eligible participants may enter a 52-week open-label extension study after this phase.
This Phase 3 study is part of Longboard’s broader DEEp Program, which aims to enroll approximately 480 participants across 80 global sites, focusing on a range of Developmental and Epileptic Encephalopathies (DEEs).
Chad Orevillo, Longboard’s Executive Vice President and Head of Operations, expressed satisfaction with the expedited progression from Phase 2 to Phase 3, emphasizing the company’s commitment to the DEEp Program’s successful execution and enrollment.
Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation, acknowledged Longboard’s progress and efficient clinical development approach, highlighting the significant unmet need in Dravet syndrome and other rare epileptic conditions.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for bexicaserin for treating seizures associated with DEEs in patients aged two years and older. Bexicaserin is characterized as a 5-HT2C receptor superagonist, showing no impact on the 5-HT2B and 5-HT2A receptor subtypes.
It is important to note that both bexicaserin and LP659, another compound being developed by Longboard, are not yet approved for marketing by the FDA or any other regulatory body. This information is based on a press release from Longboard Pharmaceuticals.
In recent updates, the FDA has granted Orphan Drug and Rare Pediatric Disease designations to bexicaserin, which may expedite its development and review process. Longboard will soon begin the Phase 3 DEEp program, starting with the DEEp SEA trial for Dravet syndrome.
Analyst notes indicate confidence in Longboard’s growth potential. H.C. Wainwright has raised its price target for Longboard to $80 with a Buy rating, while Baird maintains an Outperform rating with a $60 price target. Truist Securities has also initiated coverage with a Buy rating and a $60 price target.
Alongside bexicaserin, Longboard is developing LP659 for neuroinflammatory conditions, which has completed a Phase 1 trial. These efforts aim to address significant unmet needs in epilepsy treatment; however, both compounds remain investigational and unapproved by regulatory authorities.
Investors and industry observers are closely watching Longboard Pharmaceuticals’ clinical trials and financial health. According to InvestingPro data, the company holds a market capitalization of approximately $1.2 billion but shows a negative P/E ratio of -14.6, indicating it is not currently profitable. Longboard’s adjusted P/E ratio for the last twelve months as of Q2 2024 is -18.78, reflecting ongoing financial challenges.
Despite these challenges, Longboard’s stock performance has been robust, with a 55.45% return in the last six months, a year-to-date total return of 418.41%, and a one-year total return of 458.21%. These figures suggest strong investor confidence.
InvestingPro highlights two notable insights for Longboard Pharmaceuticals: its strong cash position relative to debt and concerns over downward revisions of analysts’ earnings forecasts. The strong cash position indicates financial stability, but the cautious earnings outlook could signal potential challenges ahead.
For further detailed analysis, additional insights are available on InvestingPro’s platform.
