Longboard Pharmaceuticals Initiates Phase 3 DEEp SEA Study Evaluating Bexicaserin in Dravet Syndrome
26 Septembre 2024 - 2:30PM
Business Wire
- First sites activated with a number of additional rapid-start
sites being activated in the coming weeks
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage
biopharmaceutical company focused on developing novel,
transformative medicines for neurological diseases, today announced
that it has initiated its global Phase 3 DEEp SEA Study evaluating
its investigational drug bexicaserin for the treatment of seizures
associated with Dravet syndrome in participants two years of age
and older.
“We are thrilled to announce the initiation of our global Phase
3 DEEp Program with our first sites activated and multiple
additional sites primed for activation within the next couple of
weeks for our DEEp SEA Study in Dravet syndrome. DEEp SEA is the
first of two trials within the DEEp Program,” stated Chad Orevillo,
Longboard’s Executive Vice President, Head of Operations. “I am
extremely proud of the team for rapidly progressing from Phase 2
data to Phase 3 initiation further underscoring our commitment to
the execution, efficiency and enrollment of our DEEp Program. We
look forward to working with the healthcare professionals, patients
and families on this important research program.”
“I am pleased to see Longboard’s recent progress in Dravet
syndrome — first, with Rare Pediatric Disease and Orphan Drug
designations, and now with the initiation of the DEEp SEA Study.
Longboard’s unique and efficient approach to clinical development
in a range of DEEs, including Dravet, is remarkable. A large unmet
need still exists not only in Dravet, but in so many other rare
epileptic conditions, and I am so happy to see continued
advancements in the space,” stated Mary Anne Meskis, Founding
Member and Executive Director of Dravet Syndrome Foundation.
About the DEEp SEA Study
The DEEp SEA Study (LP352-302) is a global Phase 3 double-blind,
placebo-controlled clinical trial to evaluate the efficacy of
bexicaserin in Dravet syndrome as assessed by countable motor
seizures in ~160 participants between the ages of two and 65 years
old. An important secondary objective is to evaluate the safety and
tolerability of bexicaserin. Following a 5-week screening period
and baseline evaluations, study participants initiate dose
titration over a 3-week period and subsequently continue on the
highest tolerated dose throughout the maintenance period of
12-weeks. Following the maintenance period, eligible participants
will be given the opportunity to enroll in the 52-week DEEp
Open-Label Extension (DEEp OLE Study LP352-303). The Phase 3 DEEp
SEA Study is part of the broader DEEp Program which will take place
across ~80 sites globally and include ~480 participants with a
range of Developmental and Epileptic Encephalopathies (DEEs).
ABOUT LONGBOARD PHARMACEUTICALS
Longboard Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on developing novel,
transformative medicines for neurological diseases. Longboard’s
small molecule product candidates are based on more than 20 years
of GPCR research. 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, is being
evaluated in a global Phase 3 clinical program (the DEEp 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. 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 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 “being”, “focus”, “primed for”, “commitment”, “look forward
to”, “objective”, “will”, “opportunity”, “working to”, “designed
to”, “plan”, 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 and
programs (including about bexicaserin, FDA designations for
bexicaserin, LP659, the DEEp Program and DEEp Sea Study,
participating sites and their activation, and participant
enrollment), 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: the standards for Breakthrough Therapy and other
designations are not the same as the standard for drug approval,
Breakthrough Therapy designation is based on preliminary clinical
evidence, 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
designation if it determines the designation is no longer supported
by subsequent data; Longboard’s product candidates are in a lengthy
research and development process, the timing, manner and outcome of
research, development and regulatory review is uncertain, and
Longboard’s product candidates, including bexicaserin and LP659,
may not advance in research or development or be approved for
marketing; enrolling participants in clinical trials is competitive
and challenging; results of clinical trials and other studies are
subject to different interpretations and may not be predictive of
future results; topline or interim data may not accurately reflect
the complete results of a particular study or trial and remain
subject to audit, and final data may differ materially from topline
or interim data; 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; 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; 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/20240926926536/en/
Megan E. Knight VP, Head of Investor Relations
IR@longboardpharma.com 858.789.9283
Longboard Pharmaceuticals (NASDAQ:LBPH)
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