- FDA agrees with Lipocine establishing LPCN 1154 pathway to
efficacy through a pharmacokinetic (PK) bridge to an approved IV
infusion brexanolone
- Lipocine has demonstrated that the brexanolone exposure of LPCN
1154 is similar to the levels observed in third trimester pregnant
women samples
- A pilot PK bridge study is planned with results expected in 1Q
2023
SALT
LAKE CITY, Sept. 15, 2022 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on
developing innovative products targeting large addressable markets
with significant unmet needs to treat central nervous system
("CNS") and metabolic disorders, announced today that the U.S. Food
and Drug Administration ("FDA") has agreed with Lipocine's proposal
for establishing the efficacy of LPCN 1154 through a single pivotal
pharmacokinetic ("PK") bridge to an approved IV infusion
brexanolone via a 505(b)(2) NDA filing. Lipocine plans
additional work in parallel to pursue a well differentiated
label.
LPCN 1154 is an oral neuroactive steroid being developed for the
treatment of PPD. It is a non-invasive oral product candidate
comprised of brexanolone, an endogenous positive allosteric
modulator of γ-aminobutyric acid ("GABA") receptor. Lipocine has
demonstrated that the brexanolone exposure of LPCN 1154 is similar
to the levels observed in third trimester pregnant women samples.
These results represent the first enablement of potentially
efficacious oral brexanolone for PPD.
"We are truly excited about the encouraging FDA pathway feedback
and oral enablement of brexanolone through leveraging of our
proprietary Lip'ral technology platform," said Dr. Mahesh
Patel, President and CEO of Lipocine Inc. "If approved, LPCN 1154
is expected to be the fastest acting oral option for PPD with
potential for out-patient use."
Lipocine plans to initiate a pilot PK bridge study of LPCN 1154
and an FDA approved IV infusion brexanolone in 4Q 2022, with
results expected in 1Q 2023.
About PPD
PPD (Postpartum depression) is a type of under diagnosed major
depressive disorder impacting approximately 1 in 7 women after
giving birth. PPD can lead to devastating consequences for a woman,
her newborn and her family. Numerous factors limit the utilization
of injectable brexanolone, including the requirement of a 60-hour
continuous IV infusion in a supervised medical setting, a demanding
ask for a mother with a newborn. Moreover, the pharmacotherapy
costs coupled with hospitalization/childcare costs limit its
accessibility and affordability to women most in need of the
therapy. Currently, there is no oral therapy approved for the
treatment of PPD.
About Lipocine
Lipocine is biopharmaceutical company employing a value-driven
strategy based on its proprietary technology platform to identify
and develop product candidates for CNS and metabolic disorders.
Lipocine has candidates in development and candidates for which we
are exploring partnering which target large addressable markets
with significant unmet medical need. Our candidates represent
enablement of patient friendly oral delivery options for favorable
benefit to risk profile. Lipocine's product candidate
pipeline includes: LPCN 1148, LPCN 1154, LPCN 2101, LPCN 1107, LPCN
1144, and LPCN 1111. 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.
Lipocine clinical development candidates include: LPCN 1154,
oral brexanolone, for the potential treatment of postpartum
depression, LPCN 1148, an oral prodrug of bioidentical testosterone
targeted for the management of symptoms associated with liver
cirrhosis, and LPCN 2101 for the potential treatment of epilepsy.
Lipocine is exploring partnering LPCN 1144, our candidate for
treatment of non-cirrhotic NASH, LPCN 1107, our candidate for
prevention of pre-term birth, and LPCN 1111, a once-a-day therapy
candidate for TRT. 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 Lipocine's 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, the potential uses and benefits of our product
candidates, and our product development efforts. Investors are
cautioned that all such forward-looking statements involve risks
and uncertainties, including, without limitation, the risks that
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.