- Initiated Single-Ascending Dose (SAD) Phase 1 clinical study evaluating LP659
LA JOLLA, CA, USA I November 29, 2023 ILongboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced the initiation of a Phase 1 randomized, double-blind, placebo-controlled, SAD clinical study of LP659. LP659 is an oral, centrally acting, next-generation sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator in development for the potential treatment of rare neuroinflammatory conditions.
“Expanding our potentially best-in-class clinical-stage pipeline with LP659 is very exciting. We founded Longboard to leverage Arena’s successful record of discovering and developing molecules with differentiated pharmacokinetics, pharmacodynamics and receptor engagement, which we believe has been validated again by the recent approval of etrasimod, an S1P receptor modulator. LP659 was designed by the same team as etrasimod with the goal of creating a next-generation, brain penetrant S1P receptor modulator while preserving its unique qualities, including avoiding activity at S1P2 and S1P3 receptor subtypes which have been associated with serious adverse events. We plan to share Phase 1 SAD data and additional clinical plans for LP659 in the first half of 2024,” stated Kevin R. Lind, Longboard’s President and Chief Executive Officer.
About the Phase 1 SAD Clinical Study
The primary objective of this Phase 1 randomized, double-blind, placebo-controlled, single-ascending dose clinical study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LP659 in up to 48 healthy adult volunteers.
LP659 is an oral, centrally acting, next-generation S1P receptor subtypes 1 and 5 (S1P1,5) modulator in development for rare neuroinflammatory conditions. Aberrant modulation of the S1P receptor has been shown to be involved in a wide range of neurological diseases. LP659 avoids S1P2,3 which may be associated with off-target adverse events. We believe LP659’s potential selectivity and specificity could result in a superior profile in the clinic compared to drugs that may not fully engage the intended GPCR target, may cause off-target activity, or may be associated with other undesirable effects.
ABOUT LONGBOARD PHARMACEUTICALS
Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Longboard is working to advance a portfolio of centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs). Longboard’s small molecule product candidates are based on more than 20 years of GPCR research. Longboard is evaluating LP352, an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor subtypes. LP352 is currently in a Phase 1b/2a clinical trial, the PACIFIC Study, evaluating participants ages 12 to 65 years old with a broad range of Developmental and Epileptic Encephalopathies (DEEs), including Lennox-Gastaut syndrome, Dravet syndrome and other DEEs. Enrollment was completed in the summer of 2023, and topline data are expected in January 2024. Longboard is also evaluating LP659, an oral, centrally acting, next-generation sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator, which is in development for the potential treatment of rare neuroinflammatory conditions in a Phase 1 single-ascending dose (SAD) clinical trial in healthy volunteers.