Longboard Pharmaceuticals to Present Late-Breaking Data from the PACIFIC Study at the American Academy of Neurology (AAN) Annual Meeting on April 15
03 Avril 2024 - 3:00PM
Business Wire
- PACIFIC Study Phase 1b/2a clinical data to be featured in a
podium presentation at an Emerging Science Session at the AAN
Annual Meeting
- Data will be featured in an encore presentation at the
Seventeenth Eilat Conference on New Antiepileptic Drugs and Devices
(EILAT XVII)
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage
biopharmaceutical company focused on developing novel,
transformative medicines for neurological diseases, today announced
that Dr. Randall Kaye, Longboard’s Chief Medical Officer, will
present late-breaking data from the PACIFIC Study evaluating
bexicaserin, an oral, centrally acting 5-HT2C receptor
superagonist, in participants with Developmental and Epileptic
Encephalopathies (DEEs) at the AAN Annual Meeting taking place
April 13-18, 2024, virtually and in Denver, Colorado.
PRESENTATION DETAILS
Title: Efficacy and Safety of Bexicaserin (LP352) in
Adolescent and Adult Patients with Developmental and Epileptic
Encephalopathies (DEEs): Results of the Phase 1b/2a PACIFIC Study
Session: Emerging Science Session (ES1) Event Type:
Scientific Platform Session Poster/Presentation Number: 003
Session Day/Time: Monday, April 15, 2024, from
11:15am-12:45pm MT Presentation Time: 11:27-11:33am MT
These data will also be presented at the Seventeenth Eilat
Conference on New Antiepileptic Drugs and Devices (EILAT XVII),
which will take place in Madrid, Spain, May 5-8, 2024.
ABOUT THE PACIFIC 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 program. The primary efficacy measure was median percent
change from baseline in countable motor seizure frequency over the
75-day treatment period.
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 “to present”, “to be”, “will”, “focused on”, “working to”,
“designed to”, “plan”, “expect”, 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
advancement (including plans for a global Phase 3 program for
bexicaserin), timing of topline data (including for the Phase 1 SAD
study for LP659), their potential (including to be transformative
or highly selective and the number and type of conditions they may
address), and their design and characteristics; upcoming
presentations (including at the AAN Annual Meeting and at EILAT
XVII); 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 phase
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; 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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CORPORATE CONTACT: Megan E. Knight VP, Head of Investor
Relations IR@longboardpharma.com 858.789.9283
Longboard Pharmaceuticals (NASDAQ:LBPH)
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