- Bexicaserin achieved an overall median seizure reduction of
57.7% in countable motor seizures over an approximate 9-month
treatment period
- Favorable safety and tolerability results continue to be
observed
- Data to be presented at the 15th European Epilepsy Congress in
Rome, Italy
- Full 12-month OLE dataset expected early next year
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 (DEEs).
“We are thrilled that bexicaserin is continuing to demonstrate a
sustained, durable response in seizure reduction and a favorable
safety and tolerability profile across a broad range of DEE
patients. 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 a full analysis of participants
with 12-month data early next year as they complete the OLE Study
and transition to our Expanded Access Program,” Dr. Kaye continued.
“With Breakthrough Therapy designation granted, we remain on track
to initiate our global Phase 3 program for bexicaserin later this
year.”
PACIFIC OLE Study Interim Analysis:
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 9-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 9-month treatment
period was a decrease of 57.7% (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 58.2% (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:
Continued favorable safety and tolerability results were
observed in this study. 100% of PACIFIC Study completers elected to
enroll in the OLE with 92.7% (38 out of 41) remaining in the
ongoing open-label study. Through the approximate nine-month
period, one participant discontinued due to the adverse event (AE)
of lethargy and two participants discontinued by withdrawal of
consent or other (relocation). The most common treatment emergent
AEs in the overall group (n=41) occurring in >5% of participants
were upper respiratory tract infections, COVID-19, pneumonia,
sinusitis, decreased appetite, pyrexia, and weight decrease.
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 the 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. The FDA has granted
Breakthrough Therapy designation for bexicaserin for the treatment
of seizures associated with Developmental and Epileptic
Encephalopathies (DEEs) for patients two years of age and older.
Earlier this year, Longboard reported positive topline data from a
Phase 1b/2a clinical trial (the PACIFIC Study) evaluating
bexicaserin in participants with 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 recently completed a Phase 1 single-ascending dose (SAD)
clinical trial for LP659 in healthy volunteers.
Bexicaserin and LP659 are investigational compounds that are not
approved for marketing by the U.S. Food and Drug Administration
(FDA) or any other regulatory authority.
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 “to be presented”, “expect”, “focus”, “potential”,
“committed to”, “on track to”, “objective”, “working to”, “designed
to”, “plans” 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 product candidates
(including their potential and design), clinical and preclinical
programs (including initiation of clinical trials, data from
clinical trials, and participants’ enrollment in or completion of
studies), plans, 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: topline or interim data may not accurately reflect the
complete results of a particular study or trial, and 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; results of clinical trials and other studies are subject
to different interpretations and may not be predictive of future
results; 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 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; the standard
for Breakthrough Therapy designation is not the same as the
standard for drug approval, the clinical evidence supporting
Breakthrough Therapy designation is preliminary, and not all drugs
designated as Breakthrough Therapies ultimately will be shown to
have substantial improvement over available therapies; the FDA may
later decide to rescind a Breakthrough Therapy designation if it
determines the designation is no longer supported by subsequent
data; 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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CORPORATE CONTACT: Megan E. Knight VP, Head of Investor
Relations IR@longboardpharma.com 858.789.9283
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