- Bexicaserin achieved an overall median seizure reduction of
56.1% in countable motor seizures over an approximate 6-month
treatment period; participants randomized to the PACIFIC placebo
group achieved a median seizure reduction of 57.3%
- Favorable safety and tolerability results observed
- 100% of participants who completed the PACIFIC Study entered
the OLE
- End of Phase 2 Meeting scheduled for this summer
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage
biopharmaceutical company focused on developing novel,
transformative medicines for neurological diseases, today announced
positive interim results from its ongoing 52-week open-label
extension of the PACIFIC Study evaluating bexicaserin (LP352) in
participants ages 12-65 years old with Developmental and Epileptic
Encephalopathies.
“We are thrilled to see a sustained, durable response in seizure
reduction and a favorable safety and tolerability profile across a
broad range of DEE patients. Additionally, we saw compelling
seizure reduction in the PACIFIC placebo patients who transitioned
to bexicaserin in the OLE. These data provide further support to
bexicaserin’s potential to offer a highly differentiated and
best-in-class profile,” stated Dr. Randall Kaye, Longboard’s Chief
Medical Officer.
“Given the tremendous unmet need in patients living with DEEs,
we are committed to rapidly advancing the development of
bexicaserin. We expect to provide additional analyses of these
participants as they progress in the OLE Study and transition to
our Expanded Access Program,” Dr. Kaye continued. “With an End of
Phase 2 meeting scheduled this summer, we remain on track to
initiate our global Phase 3 program for bexicaserin later this
year.”
PACIFIC OLE Study Interim Analysis Results:
The PACIFIC OLE Study is a 52-week Phase 2, open-label,
long-term safety study of bexicaserin in participants with a range
of DEEs, including Dravet syndrome (n=3), Lennox-Gastaut syndrome
(n=20) and DEE Other (n=18), who completed the PACIFIC Study
(n=41). The study objectives are to investigate the safety and
tolerability of multiple doses of bexicaserin in participants with
DEEs, and to analyze the effect of bexicaserin on the frequency of
observed countable motor seizures and other seizure types. The
interim analysis was conducted when participants reached the
approximate 6-month point in the OLE Study.
Summary of Efficacy Results:
The median change in countable motor seizure frequency for
participants in the OLE Study over an approximate 6-month treatment
period was a decrease of 56.1% (n=40) from their baseline entering
the PACIFIC Study.
The median change in countable motor seizure frequency from
baseline for:
- participants randomized to the bexicaserin-treated group in the
PACIFIC Study was a decrease of 54.9% (n=31)
- participants randomized to the placebo group in the PACIFIC
Study that transitioned to bexicaserin in the OLE was a decrease of
57.3% (n=9)
Summary of Safety and Tolerability Results:
Favorable safety and tolerability results were observed in this
study. 100% of PACIFIC Study completers elected to enroll in the
OLE with 95.1% (39 out of 41) remaining in the ongoing open-label
study. One participant discontinued due to the adverse event (AE)
of lethargy and one participant discontinued by withdrawal of
consent. The most common treatment emergent AEs in the overall
group (n=41) occurring in >5% of patients were upper respiratory
tract infections, COVID-19, pneumonia, sinusitis, seizures, and
decreased appetite.
ABOUT THE PACIFIC STUDY AND THE OLE STUDY
The PACIFIC Study is a Phase 1b/2a double-blind,
placebo-controlled clinical trial to assess the safety,
tolerability, efficacy and pharmacokinetics of bexicaserin (LP352)
in 52 participants between the ages of 12 and 65 years old with
DEEs at 34 sites across the United States and Australia. Following
a 5-week screening period and baseline evaluations, study
participants initiated a dose titration over a 15-day period and
subsequently continued on the highest tolerated dose throughout the
maintenance period of 60 days. Following the maintenance period,
participants were then titrated down, and eligible participants
were given the opportunity to enroll in a 52-week open-label
extension study.
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 plans to advance bexicaserin (LP352), an oral,
centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor
superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor
subtypes, into a global Phase 3 program. Longboard recently
reported positive topline data from a Phase 1b/2a clinical trial
(the PACIFIC Study) evaluating bexicaserin in participants ages 12
to 65 years old with Developmental and Epileptic Encephalopathies
(DEEs), including Lennox-Gastaut syndrome, Dravet syndrome and
other DEEs. Longboard is also evaluating LP659, an oral, centrally
acting, sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5
modulator, which is in development for the potential treatment of
rare neuroinflammatory conditions. Longboard is conducting a Phase
1 single-ascending dose (SAD) clinical trial for LP659 in healthy
volunteers, with topline data expected in the second quarter of
2024.
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”, “potential”, “expect”, “committed to”,
“scheduled”, “remain on track”, “working to”, “designed to”,
“plans”, “will”, or the negative, plural or other tenses of these
words, references to future dates or time periods, or other
comparable language, and they may include, without limitation,
statements about the following: Longboard’s clinical and
preclinical product candidates and programs, including their
potential (including for bexicaserin to be differentiated and to
have a best-in-class profile), advancement, timing of initiating
clinical trials (including a global Phase 3 program for
bexicaserin), timing of topline data from clinical trials
(including the Phase 1 SAD data for LP659), , the end of Phase 2
meeting, the ability of patients to progress in the OLE Study and
transition to an expanded access program, 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: risk that topline or interim
data may not accurately reflect the complete results of a
particular study or trial, and that final data may differ
materially from topline or interim data; PACIFIC Study
participants' diagnoses are as of time of screening and are subject
to change; risks related to Longboard’s limited operating history,
financial position and need for additional capital; Longboard’s
need for 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 to
middle 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;
results of clinical trials and other studies are subject to
different interpretations and may not be predictive of future
results; enrolling participants in Longboard’s ongoing and intended
clinical trials is competitive and challenging; 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; macroeconomic
events and their impact on Longboard's clinical trials and
operations, the operations of Longboard's suppliers, partners,
collaborators, and licensees, and capital markets; 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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version on businesswire.com: https://www.businesswire.com/news/home/20240610482365/en/
CORPORATE CONTACT: Megan E. Knight VP, Head of Investor
Relations IR@longboardpharma.com 858.789.9283
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