Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage
biopharmaceutical company focused on developing novel,
transformative medicines for neurological diseases, announced today
that the Company successfully completed the multiple ascending dose
(MAD) portion of a Phase 1 clinical trial to assess the safety,
tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
escalating doses of LP352, an oral, centrally acting,
next-generation 5-HT2c receptor superagonist, in healthy
volunteers. Longboard plans to advance LP352 into a Phase 1b/2a
efficacy trial in adult participants with DEEs in the first quarter
of 2022 in study sites across the United States.
"We are very pleased that we achieved the goals
of this trial, which were to explore the safety, tolerability, PK
and PD of LP352 at several dose levels and determine the optimal
expected dose range for our upcoming efficacy trial. We are
encouraged by the initial safety and tolerability characteristics
of LP352 observed in the trial and that it appears to have a potent
effect on the 5-HT2c pathway," stated Dr. Phil Perera, Longboard’s
Chief Medical Officer. "We believe LP352 has the potential to
reduce seizures in a broad range of severe and devastating,
treatment-resistant epilepsies, and we look forward to advancing
the program in patients living with these debilitating
disorders."
Phase 1 Trial:The LP352 Phase 1
trial (N=83) was a first-in-human, randomized, placebo-controlled,
double-blind, four-part trial including single ascending dose (SAD)
and MAD assessments in healthy volunteers. The primary objectives
of the trial were to evaluate safety, tolerability, PK & PD of
LP352.
In the MAD portion (N=43) of the trial, five
doses including the maximum planned dose were evaluated. The
majority of adverse events (AEs) were mild to moderate, with the
most common being headache. A single serious adverse event (SAE) of
anxiety was reported at the maximum planned dose two days after the
last dose of study drug and subsequently resolved. AEs were
generally consistent with central nervous system (CNS) effects and
expected effects of serotonergic drugs.
LP352 demonstrated dose- and exposure-dependent
increases of prolactin, suggesting proof of central 5-HT2c receptor
engagement, as well as dose-dependent increases in exposure (Cmax
and AUCtau).
About LP352LP352 is an oral,
centrally acting, next-generation 5-HT2c receptor superagonist in
development for the potential treatment of seizures associated with
DEEs such as Dravet syndrome, Lennox-Gastaut syndrome (LGS),
tuberous sclerosis complex (TSC), CDKL5 deficiency disorder, and
other epileptic disorders. LP352 is designed to modulate GABA
inhibition and, as a result, suppress the central hyperexcitability
that is characteristic of seizures. LP352 has demonstrated
negligible observed impact on 5-HT2b and 5-HT2a receptor subtypes
in the Company’s preclinical studies to date. 5-HT2b and 5-HT2a
receptor agonism have been associated with significant adverse
effects. LP352 has novel chemistry and attributes, and was designed
to be more specific and selective for the 5-HT2c receptor subtype,
giving it the potential to reduce seizures in DEE patients while
overcoming the known or perceived safety limitations of available
drugs in the 5-HT2 class.
About Developmental and Epileptic
EncephalopathiesDEEs refer to a group of severe epilepsies
that are characterized both by seizures, which are often
drug-resistant, as well as encephalopathy, which is a term used to
describe significant developmental delay or even loss of
developmental skills. In the DEEs, there are two factors that
contribute to the developmental delay:
- Developmental encephalopathy
implies that developmental delays are the direct result of the
underlying cause of their epilepsy.
- In addition, some children with
DEEs also have an epileptic encephalopathy due to very frequent
seizures and markedly abnormal EEGs, which may substantially worsen
developmental problems.
Importantly, if seizure control can be improved,
the epileptic encephalopathy component of the delay may
improve.
Most DEEs begin early in life, often starting in
infancy. Children can have very 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 was
formed in January 2020 by Arena Pharmaceuticals, Inc. (Arena) 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 were
discovered out of the same platform at Arena that represents a
culmination of more than 20 years of GPCR research. Longboard is
evaluating LP352, an oral, centrally acting, next-generation
5-hydroxytryptamine 2c receptor superagonist, with negligible
observed impact on 5-HT2b and 5-HT2a receptor subtypes, in
development for the potential treatment of seizures associated with
developmental and epileptic encephalopathies. Longboard is also
evaluating LP143, a centrally acting, full cannabinoid type 2
receptor agonist, in development for the potential treatment of
neurodegenerative diseases associated with neuroinflammation caused
by microglial activation, and LP659, a centrally acting,
sphingosine-1-phosphate receptor subtypes 1 and 5 modulator, in
development for the potential treatment of central nervous system
neuroinflammatory diseases.
Forward-Looking
StatementsCertain 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 “expected,” “potential,” “plan,”
“anticipate,” “focused on,” and “look forward” and include, without
limitation, statements about the following: Longboard’s clinical
and preclinical programs, including plans to advance LP352 in a
Phase 1b/2a clinical trial; LP352’s safety, tolerability, PK
and PD profile and effect on the 5-HT2c pathway; LP352’s potential
to reduce seizures; the potential disease treatments of LP143 and
LP659; and our focus. 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 the 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; continued clinical development of LP352 is
dependent on the acceptance and approval of our investigational new
drug application by the U.S. Food and Drug Administration’s (FDA)
Division of Neurology; enrolling participants in clinical
trials is competitive and challenging; the duration and severity of
the coronavirus disease (COVID-19) outbreak, 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; 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, including lack
of control and potential disputes; the entry into or modification
or termination of 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.
Corporate Contact:
Megan E. Knight
Head of Investor Relations
mknight@longboardpharma.com
IR@longboardpharma.com
619.592.9775
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