- LP352 exhibited a strong correlation between plasma and
cerebrospinal fluid (CSF) pharmacokinetics (PK) concentration,
which increased in a dose-dependent and consistent manner
- LP352 demonstrated early quantitative electroencephalogram
(qEEG) changes, and sustained effects on qEEG activity after
continuous dosing in a dose-dependent manner indicating receptor
engagement
- Favorable safety and tolerability results were observed in this
study, with adverse events (AEs) generally consistent with previous
clinical studies
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage
biopharmaceutical company focused on developing novel,
transformative medicines for neurological diseases, today announced
positive topline results from a Phase 1 clinical study evaluating
the central nervous system (CNS) pharmacokinetics (PK) and
pharmacodynamics (PD) of LP352, an oral, centrally acting 5-HT2C
superagonist, in healthy volunteers.
"We are excited to share data from our 102 study, the first
known of its kind for a 5-HT2 receptor agonist, to further
elucidate the potentially best-in-class profile of LP352. We
believe the results of this study are encouraging as orally
administered LP352 plasma and CSF PK concentration increased in a
dose-dependent and consistent manner, a clear indicator that LP352
is crossing the blood brain barrier. Furthermore, the observation
of demonstrated effects on qEEG activity within the first few doses
and after continuous dosing suggests that LP352 engaged
neurotransmitter systems and altered the EEG spectrum. We are
pleased to see favorable safety and tolerability results in this
study, consistent with previous work we have conducted," stated Dr.
Randall Kaye, Longboard’s Chief Medical Officer. "We anticipate
sharing additional data to substantiate our belief that LP352 has
the potential to be a safer and more efficacious treatment of
seizures in a broad range of developmental and epileptic
encephalopathies (DEEs), and we look forward to providing updates
on the ongoing Phase 1b/2a PACIFIC study as they become
available."
Study Design & Objectives:
The primary objectives of this open-label, Phase 1 study are to
assess the CNS PK and PD of orally administered LP352 in healthy
adult male and female participants (n=10 in each Cohort).
Objectives include the characterization of plasma and CSF PK, the
characterization of safety and tolerability of doses with titration
and taper, and the assessment of the PK-PD relationships between
plasma and CSF exposure, and PD endpoints of safety and efficacy,
including quantitative electroencephalogram (qEEG) endpoints. Data
being shared today relate to two doses (Cohort 1 = 6 mg and Cohort
2 = 12 mg) of LP352 three times daily (TID) that were tested over a
16-day period in addition to a screening and follow-up period.
Additional cohorts of the study are ongoing.
Plasma/CSF Results:
Plasma samples were obtained on Day 1 through Day 11 (and during
taper), measuring maximum concentration (Cmax), time of peak plasma
concentration (Tmax), and area under the curve (AUCtau). Serial CSF
samples were taken on Day 11 at multiple timepoints.
At steady state, LP352 12 mg TID mean concentrations exceeded
the Ki value for 5-HT2C activity throughout the dosing interval.
The vast majority of participants in Cohort 2 achieved plasma and
CSF levels above the relevant Ki throughout the dosing period at
steady state. LP352 exhibited a strong correlation between plasma
and CSF PK concentration, which increased in a dose-dependent and
consistent manner.
qEEG Results:
Serial EEGs were taken at Days -1, 1, 3 & 10, and Day 16 (at
trough). LP352 demonstrated early qEEG changes within the first few
doses. LP352 also demonstrated sustained, dose-dependent effects on
qEEG activity after continuous dosing, thus indicating receptor
engagement. LP352 engaged neurotransmitter systems and altered the
EEG spectrum.
Safety / Tolerability Findings:
Favorable safety and tolerability across both cohorts were
observed, with AEs generally consistent with previous clinical
studies of LP352.
About LP352
LP352 is an oral, centrally acting 5-HT2C superagonist in
development for the potential treatment of seizures associated with
developmental and epileptic encephalopathies (DEEs) such as Dravet
syndrome, Lennox-Gastaut syndrome (LGS), tuberous sclerosis complex
(TSC), CDKL5 deficiency disorder (CDD), and other epileptic
disorders. LP352 is designed to modulate GABA and, as a result,
suppress the central hyperexcitability that is characteristic of
seizures. LP352 has no detected activity at the 5-HT2B and 5-HT2A
receptor subtypes. 5-HT2B and 5-HT2A receptor agonism have been
associated with significant adverse side effects. LP352 has novel
chemistry and attributes. It was designed to be more specific and
selective for the 5-HT2C receptor subtype, giving it the potential
to reduce seizures in patients with DEEs while overcoming the known
or perceived safety limitations of available drugs in the 5-HT2
class. LP352 is currently being evaluated in an ongoing Ph 1b/2a
clinical trial (the PACIFIC Study) in participants with DEEs, with
data expected in the second half of 2023, as well as in additional
supportive studies.
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
detected activity at the 5-HT2B and 5-HT2A receptor subtypes. LP352
is currently being evaluated in a Phase 1b/2a clinical trial, the
PACIFIC Study, and being developed for the potential treatment of
seizures associated with a broad range of developmental and
epileptic encephalopathies (DEEs). Longboard is also evaluating
LP659, a centrally acting, sphingosine-1-phosphate (S1P) receptor
subtypes 1 and 5 modulator, in development for the potential
treatment of multiple neurological diseases. Longboard holds rights
to other product candidates, including LP143 and nelotanserin,
through a License Agreement with Arena Pharmaceuticals, Inc.
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 “potential”, “focused on”, “anticipate”, “expects” and
“advance”, and include, without limitation, statements about the
following: the potential of LP352, including to be a safer and more
efficacious treatment of seizures associated with DEEs and in a
broad range of DEEs, to be best-in-class, and reduce seizures in
patients with DEEs while overcoming the known or perceived safety
limitations of available drugs in the 5-HT2 class; the timing and
results of clinical data for LP352; updates on the Company’s
Pacific Study; the potential for LP659, including to treat multiple
neurological diseases, and the Company’s other product candidates;
and the Company’s focus and ability to advance a portfolio of
product candidates. 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: topline data may not reflect the
complete or final results of a particular study or trial, and are
subject to change; risks related to Arena’s acquisition by Pfizer;
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 continuing development or marketing; the regulatory
process of the U.S. Food and Drug Administration and comparable
foreign authorities is lengthy, time consuming and inherently
unpredictable; enrolling participants in Longboard’s ongoing and
intended clinical trials is competitive and challenging; the impact
of geopolitical and macroeconomic events, including the COVID-19
pandemic, 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; 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 Head of Investor
Relations IR@longboardpharma.com 619.592.9775
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