Longboard Pharmaceuticals Announces Initiation of First-in-Human Phase 1 Clinical Study of LP659 in Adult Healthy Volunteers
November 29 2023 - 8:30AM
Business Wire
- 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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Megan E. Knight Head of Investor Relations
IR@longboardpharma.com 858.789.9283
Longboard Pharmaceuticals (NASDAQ:LBPH)
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