- Enrolled 52 participants with Developmental and Epileptic
Encephalopathies (DEEs) into the PACIFIC Study
- Participants have a broad range of DEEs including
Lennox-Gastaut syndrome, Dravet syndrome, SCN2A-related epilepsies,
CDKL5 deficiency disorder, among others
- PACIFIC topline results remain on track for around year-end
2023
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage
biopharmaceutical company focused on developing novel,
transformative medicines for neurological diseases, today announced
that it has completed enrollment of its Phase 1b/2a clinical trial,
the PACIFIC Study, which is evaluating LP352, an oral, centrally
acting 5-HT2C receptor superagonist, in 52 participants with
Developmental and Epileptic Encephalopathies (DEEs). The primary
objectives of the study are to assess the safety and tolerability
of LP352. The PACIFIC Study will also evaluate change in seizure
frequency over the treatment period, and data are expected to
inform the design and characteristics of the planned Phase 3
program for LP352. Participants who complete the PACIFIC Study are
eligible to roll over into the ongoing open-label extension trial
should they choose to do so.
“Completing enrollment of the PACIFIC Study is a tremendous
milestone for Longboard and we are very pleased to see strong
interest from the DEE patient community, underscoring the great
unmet need that remains,” stated Dr. Randall Kaye, Longboard’s
Chief Medical Officer. “We would like to thank the entire DEE
community, including participants, their families and the
advocates, as well as the investigators, sites and coordinators for
their participation and continued collaboration. This achievement
brings us one step closer to helping people living with
Developmental and Epileptic Encephalopathies.”
“I am excited about the innovative approach of conducting
clinical research in DEEs more broadly given the significant unmet
need and limited access to novel and targeted therapies that exists
in the majority of patients living with refractory epilepsies. I
look forward to seeing the PACIFIC data and the potential of
LP352,” said Dennis Dlugos, MD, MSCE, pediatric neurologist at
Children's Hospital of Philadelphia, Vice President & Officer
of the Epilepsy Study Consortium, and Principal Investigator of the
PACIFIC Study.
“We are pleased to see Longboard’s commitment to advancing the
rare and refractory epilepsy space. The inclusive nature of the
PACIFIC Study is unique and exciting, especially given that people
living with certain DEEs have not had access to newer therapies and
clinical trials,” said Tracy Dixon-Salazar, PhD, Executive Director
of the LGS Foundation. “There is a dire need for continued
improvement in research and innovation for these severe syndromes,
and we are looking forward to the outcome of the PACIFIC
Study.”
ABOUT THE PACIFIC STUDY
The PACIFIC Study is a Phase 1b/2a clinical trial evaluating
participants with Developmental and Epileptic Encephalopathies
(DEEs). The primary objectives of the study are to assess the
safety and tolerability of LP352. The PACIFIC Study will also
evaluate change in seizure frequency over the treatment period. The
study enrolled 52 participants with a variety of treatment
resistant seizures that fall into the category of DEE across
approximately 30 study sites in the United States and Australia.
The PACIFIC Study data are expected to inform the design and
characteristics of the planned Phase 3 program for LP352.
Participants who complete the PACIFIC Study are eligible to roll
over into the ongoing open-label extension (OLE) trial should they
choose to do so. The OLE is a Phase 2 multicenter, open-label,
multiple-dose, long-term extension clinical trial designed to
evaluate long-term safety of LP352 in participants with DEEs who
have completed the PACIFIC Study.
ABOUT DEVELOPMENTAL AND EPILEPTIC ENCEPHALOPATHIES
DEEs refer to a group of severe heterogeneous epilepsies that
are characterized by drug resistant seizures and significant
developmental delay.
Importantly, if seizure control can be improved, developmental
delay may slow. Most DEEs begin early in life, often starting in
infancy. Children can have frequent and severe seizures which may
be of multiple types. Epileptic spasms, tonic or atonic seizures
and myoclonic seizures, among other seizure types, can be seen. In
many cases, seizures are life long, although in some instances they
can abate with time with certain syndromes or specific causes.
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
detectable activity on 5-HT2B and 5-HT2A receptor subtypes, in
development for the potential treatment of seizures associated with
a broad range of Developmental and Epileptic Encephalopathies.
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 multiple
neurological diseases.
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 “on track”, “target”, “objective”, “will”, “expect”,
“plan”, “eligible to”, “goal”, “closer to”, “look forward to”,
“potential”, “commitment”, “designed to”, “can”, “may”, “focused
on”, “working to”, or the negative, plural or other tenses of these
words or other comparable language, and they include, without
limitation, statements about the following: the potential of LP352,
including to advance into a Phase 3 program, treat seizures
associated with a broad range of DEEs, or address an unmet need
among people living with DEEs; the PACIFIC Study, including study
participants completing the PACIFIC Study and rolling over into the
OLE trial, the timing of topline results from the PACIFIC Study,
and the potential for such results to inform a planned Phase 3
program for LP352; the potential for seizures to abate with time
with certain syndromes or specific causes; the design,
characteristics and potential of Longboard’s product candidates;
and Longboard’s commitment, 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: Longboard’s product candidates, including LP352,
are in the early to middle stages of a lengthy research,
development, and regulatory review process, the timing, manner and
outcome of which is uncertain, and Longboard’s product candidates
may not advance in research or development or be approved for
marketing; 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;
enrolling participants in Longboard’s ongoing and intended clinical
trials is competitive and challenging; other risks related to the
development and commercialization of Longboard’s product
candidates; 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; macroeconomic events stemming
from the COVID-19 pandemic or evolving geopolitical developments
such as the conflict in Ukraine, 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;
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/20230823110631/en/
Megan E. Knight Head of Investor Relations
IR@longboardpharma.com 858.789.9283
Longboard Pharmaceuticals (NASDAQ:LBPH)
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