- Positive clinical study results confirm 48-hour dosing
regimen for the pivotal PK study
- On track for Q2-24 pivotal study topline results and planned
Q4-24 NDA filing
SALT
LAKE CITY, Feb. 6, 2024 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a biopharmaceutical company focused on treating
Central Nervous System (CNS) disorders by leveraging its
proprietary platform, today announced that results from a
multi-dose clinical study have confirmed the LPCN 1154 48-hour
dosing regimen for the upcoming NDA enabling pivotal
pharmacokinetic (PK) study. LPCN 1154 is an oral neurosteroid being
developed by Lipocine for the treatment of postpartum depression
(PPD).
PPD is a major depressive disorder with onset either during
pregnancy or within four weeks of delivery, with symptoms
persisting for up to 12 months after childbirth. There is an
unmet need for an oral fast-acting product with an improved
efficacy and safety profile to treat PPD. Oral LPCN 1154 comprising
a bioidentical neuroactive steroid with 48-hour outpatient dosing
is targeted to provide rapid relief with robust efficacy.
Lipocine has previously confirmed with the U.S. Food and Drug
Administration (FDA) acceptance of a proposal for a 505(b)(2) NDA
filing based on a single pivotal study comparing exposure of LPCN
1154 with the approved IV infusion of brexanolone. Following
a successful meeting with the FDA, Lipocine reached agreement on
the use of exposure parameters and criteria to assess comparable
exposure to IV infusion brexanolone.
Based on positive results of the 2023 multi-arm crossover pilot
PK study, Lipocine recently completed a single arm PK study (N=8)
utilizing the "to be marketed" formulation and target dosing
regimen. PK exposure results of the "to be marketed" scaled up
formulation were consistent with the PK performance of pilot study
clinical formulation. Furthermore, the exposure PK parameters
observed in this study are comparable to those of IV infusion
brexanolone administered per label instructions in the pilot study.
There were no serious or severe adverse events observed in this
single arm, multi-dose study, and a single report of asymptomatic,
moderate decrease of oxygen saturation. Consistent with the
goal of NDA submission by the end of the fourth quarter of 2024,
the company anticipates top line results late in the second quarter
of 2024 from the crossover pivotal study of LPCN 1154 with the
reference product IV brexanolone.
"We believe these results support the design of the planned
NDA enabling pivotal study," said Dr. Mahesh Patel, President
and CEO of Lipocine. "LPCN 1154 is targeted to be a highly
effective, oral, fast-acting and short duration treatment option
for PPD, a serious and potentially life-threatening condition. We
believe a 48-hour oral dosing duration will be important for
patients and caregivers. If approved, LPCN 1154 has the
potential to be a differentiated preferred treatment option for
PPD."
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development
targeted for administration resulting in rapid relief of postpartum
depression (PPD). Brexanolone is a bioidentical to naturally
occurring neuro active steroid, allopregnanolone, a positive
allosteric modulator of y-aminobutyric acid (GABA)
receptor. LPCN 1154 is expected to have characteristics that
could be particularly appealing to patients with severe PPD,
acutely elevated suicide risk, and in whom rapid
improvement is a priority while presenting no significant risk
of adverse reactions to breastfed infants from exposure to
brexanolone.
About Postpartum Depression and Unmet Needs:
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. Hormonal changes
leading to GABA dysfunction are common in depression and pregnancy.
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. Results from a recent survey (Truist Securities
Research, January 2024) show that
obstetricians believe approximately 20-40% of their patients may
suffer from PPD. Further, obstetricians are comfortable making a
diagnosis and prescribing antidepressants for PPD. Traditional
antidepressants, not approved for PPD, have slow onset of action,
side effects such as sexual dysfunction and weight gain, and do not
demonstrate adequate remission post-acute treatment. The
current approved standard of care is a continuous infusion of
intravenous brexanolone which requires inpatient administration and
has significant limitations.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop differentiated products for CNS
disorders. Lipocine has drug candidates in development as well as
drug candidates for which we are exploring partnering. Our drug
candidates represent enablement of differentiated, patient friendly
oral delivery options for favorable benefit to risk profile which
target large addressable markets with significant unmet medical
needs.
Lipocine's 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, a novel androgen receptor agonist prodrug for oral
administration 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, LPCN1154, for rapid relief of postpartum depression,
LPCN 1148, for the management of decompensated cirrhosis, and LPCN
1144, our candidate for treatment of non-cirrhotic NASH.
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, the
application of our proprietary platform in developing new
treatments for CNS disorders, our product candidates and related
clinical trials, the timing and outcome of product studies, our
development of and filing of a NDA with the FDA for LPCN 1154, 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 have sufficient
capital to complete the development processes for our product
candidates, 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 and
our ability to utilize a streamlined approval pathway for LPCN
1154, 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.