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Longboard Pharmaceuticals Announces Initiation of First-in-Human Phase 1 Clinical Study of LP659 in Adult Healthy Volunteers

  • Initiated Single-Ascending Dose (SAD) Phase 1 clinical study evaluating LP659

Longboard 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.

About LP659

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.

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 “focus”, “in development for”, “potential”, “believe”, “goal”, “plan”, “first half of 2024”, “objective”, “may”, “could”, “working to”, “designed to”, “expect”, “January 2024”, “later this year”, or the negative, plural or other tenses of these words or other comparable language, and they may include, without limitation, statements about the following: the vesting of stock options; continued employment of newly hired Longboard employees; Longboard’s clinical and preclinical product candidates and programs, including their advancement, timing of initiation and completion of clinical trials, timing of topline data from clinical trials, characteristics of clinical trial participants, plans for future clinical trials, their potential (including to be highly selective, have differentiated pharmacokinetics, pharmacodynamics and receptor engagement, have unique qualities associated with other compounds, have a superior profile, and the numbers and types of conditions they may address), and their design and characteristics; Longboard’s ability to develop product candidates and deliver medicines; and Longboard’s 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: 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; Longboard’s product candidates are in the early phases of a lengthy research and development process, the timing, manner and outcome of research, development and regulatory review is uncertain, and Longboard’s product candidates may not advance in research or development or be approved for marketing; enrolling participants in Longboard’s ongoing and intended clinical trials is competitive and challenging; PACIFIC Study participants’ diagnoses are as of time of screening and are subject to change; macroeconomic events stemming from the COVID-19 pandemic or evolving geopolitical developments such as the conflicts in Ukraine and the Middle East, including but not limited to the impact on Longboard’s clinical trials and operations, the operations of Longboard’s suppliers, partners, collaborators, and licensees, and capital markets, which in each case remains uncertain; 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; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; 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.

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