Results demonstrate improvements in sarcopenia
and other clinically meaningful outcomes
Patients converting from placebo to LPCN 1148 in
the ongoing open label extension also showed improvement in
sarcopenia
SALT
LAKE CITY, Nov. 13, 2023 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on
treating Central Nervous System (CNS) disorders, today announced
that results of its Phase 2 study evaluating LPCN 1148 are being
presented at The American Association for the Study of Liver
Diseases (AASLD) – The Liver Meeting® 2023, taking place in
Boston MA. The results are
featured in a late-breaking oral presentation and e-poster by Dr.
Arun Sanyal, MD, Director,
Stravitz-Sanyal Institute for Liver Disease and Metabolic Health,
Virginia Commonwealth University,
advisor to Lipocine.
"We are very pleased to share the data from our successful Phase
2 study of LPCN 1148 with the hepatology community at this year's
Liver Meeting," said Dr. Mahesh
Patel, President and CEO of Lipocine. "The data show
that LPCN 1148 improved multiple additional clinically meaningful
and surrogate outcomes, including hepatic encephalopathy. An Open
Label Extension is now ongoing, and we look forward to reporting
further data in Q1 2024."
The Phase 2 proof of concept study (NCT # 04874350) is a 52-week
ongoing randomized placebo-controlled study in sarcopenic male
patients with cirrhosis on the liver transplant
waitlist. After week 24, all patients enter a single arm
open-label extension ("OLE") stage of the study and receive LPCN
1148. The purposes of the OLE are 1) to evaluate the safety
and efficacy of continued exposure with LPCN 1148 in this
population, and 2) to increase the number of participants on LPCN
1148 treatment.
A copy of the presentation and e-poster will be available on the
Lipocine corporate website.
About LPCN 1148
Lipocine is currently evaluating LPCN 1148 comprising
testosterone laurate ("TL") for the management of decompensated
cirrhosis. The Company believes LPCN 1148 targets unmet needs for
cirrhosis subjects including improvement in the quality of life of
patients while on the liver transplant waiting list, prevention or
reduction in the occurrence of new decompensation events such as
hepatic encephalopathy ("HE"), and improvement in post liver
transplant survival, including outcomes and costs.
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, 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, the
application of our proprietary platform in developing new
treatments for CNS disorders, our product candidates and related
clinical trials, our development of and filing of a NDA with the
FDA for LPCN 1148,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.