- LPCN 1154 is an oral formulation of brexanolone in development
for the rapid relief of postpartum depression (PPD)
- Topline study results expected in H1 2023
SALT
LAKE CITY, April 3, 2023 /PRNewswire/ --
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company
focused on treating Central Nervous System (CNS) disorders by
leveraging its proprietary platform to develop differentiated
products, today announced that the first participant has been dosed
in a pilot clinical bridge study of LPCN 1154 (oral brexanolone)
and approved injectable brexanolone. The U.S. Food and
Drug Administration (FDA) has agreed with Lipocine's proposal for
establishing the efficacy and safety of LPCN 1154 in women with PPD
through a clinical (pharmacokinetic) bridge to an approved IV
infusion of brexanolone via a 505(b)(2) NDA filing. Lipocine
plans to conduct a pivotal study designed to support NDA filing
pending results from the pilot clinical bridge
study.
LPCN 1154 is targeted to be a rapid onset "at home"
oral treatment option for PPD with improved treatment access and
ease of use without disrupting bonding/breast feeding interactions
compared to the current, approved PPD standard of care with its
significant limitations.
The pilot clinical bridge study is an open label, randomized,
partial crossover study. The primary objective of the study is to
compare the exposures of multidose regimens of orally administered
LPCN 1154 and a continuous IV infusion of brexanolone in healthy
postmenopausal women and to inform the dose selection for the
pivotal study. The secondary objective is to evaluate the safety
and tolerability of multidose regimens of oral LPCN 1154. The study
is expected to enroll a total of 12 participants and is being
conducted at a single center in the US. Results are expected in the
first half of 2023.
"We are excited about our development progress for LPCN 1154,"
said Dr. Mahesh Patel, President and CEO of Lipocine
Inc. "The days and weeks after childbirth are critical time
periods for the care of both mother and newborn, with urgent relief
a high priority for patients with depression," continued Dr. Patel.
"We believe that, if approved, LPCN 1154, comprising a bioidentical
active, has the potential to be a differentiated treatment for PPD,
providing a convenient oral treatment option for administration in
outpatient settings that would be less burdensome on patients,
caregivers, and providers."
About LPCN 1154
LPCN 1154 is an oral formulation of the neuroactive steroid
brexanolone for self-administration in development for the
treatment of PPD. The active moiety in LPCN 1154 is a
bioidentical positive allosteric modulator of y-aminobutyric acid
(GABA) receptor.
About Postpartum Depression
PPD is a major depressive disorder with onset either during
pregnancy or within four weeks of delivery, with symptoms
persisting up to 12 months after childbirth. Symptoms of PPD
include hallmarks of major depression, including, but not limited
to, sadness, depressed mood, loss of interest, change in appetite,
insomnia, sleeping too much, fatigue, difficulty
thinking/concentrating, excessive crying, fear of harming the
baby/oneself, and/or thoughts of death or suicide. Approximately
500,000 women are affected by PPD annually in the United States, and according to the CDC,
an estimated 175,000 women suffer from moderate to severe PPD, and
10-15% of PPD patients have severe depression. The current
approved standard of care is continuous infusion of intravenous
brexanolone which requires inpatient administration with frequent
monitoring.
About Lipocine
Lipocine is a biopharmaceutical company
leveraging its proprietary technology platform to augment
therapeutics through effective oral delivery to develop products
for CNS disorders. Lipocine has candidates in development as well
as candidates for which we are exploring partnering. Our candidates
represent enablement of patient friendly oral delivery options for
favorable benefit to risk profile which target large addressable
markets with significant unmet medical needs.
Lipocine clinical development candidates include: LPCN 1154,
oral brexanolone, for the potential treatment of postpartum
depression, LPCN 2101 for the potential treatment of epilepsy and
LPCN 1148, an oral prodrug of bioidentical testosterone targeted
for the management of symptoms associated with liver cirrhosis.
Lipocine is exploring partnering opportunities for LPCN 1107,
our candidate for prevention of preterm birth, LPCN 1148, for the
management of decompensated cirrhosis, LPCN 1144, our candidate for
treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day
therapy candidate for testosterone replacement therapy (TRT).
TLANDO, a novel oral prodrug of testosterone containing
testosterone undecanoate developed by Lipocine, is approved by the
FDA for conditions associated with a deficiency of endogenous
testosterone, also known as hypogonadism, in adult males. For
more information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains
"forward-looking statements" that are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995 and include statements that are not historical facts
regarding our product development efforts, our strategic plans for
developing products to treat CNS disorders, our ability to monetize
non-core product candidates, including through entering into
partnering arrangements, the application of our proprietary
platform in developing new treatments for CNS disorders, our
product candidates and related clinical trials, the achievement of
milestones within and completion of clinical trials, the timing and
completion of regulatory reviews, outcomes of clinical trials of
our product candidates, and the potential uses and benefits of our
product candidates. Investors are cautioned that all such
forward-looking statements involve risks and uncertainties,
including, without limitation, the risks that we may not be
successful in developing product candidates to treat CNS disorders,
we may not be able to enter into partnerships or other strategic
relationships to monetize our non-core assets, the FDA will not
approve any of our products, risks related to our products,
expected product benefits not being realized, clinical and
regulatory expectations and plans not being realized, new
regulatory developments and requirements, risks related to the FDA
approval process including the receipt of regulatory approvals, the
results and timing of clinical trials, patient acceptance of
Lipocine's products, the manufacturing and commercialization of
Lipocine's products, and other risks detailed in Lipocine's filings
with the SEC, including, without limitation, its Form 10-K and
other reports on Forms 8-K and 10-Q, all of which can be obtained
on the SEC website at www.sec.gov. Lipocine assumes no
obligation to update or revise publicly any forward-looking
statements contained in this release, except as required by
law.
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SOURCE Lipocine Inc.