SALT
LAKE CITY, May 8, 2024 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a biopharmaceutical company, today announced that
data from the Phase 2 study of LPCN 1148 has been selected for a
late breaking oral presentation at the European Association for the
Study of Liver ("EASL") Congress, to take place June 5 to 8, 2024 in Milan, Italy.
Presentation Details
Title
|
Intervention with
oral LPCN 1148 improves sarcopenia and hepatic encephalopathy
("HE") in patients with cirrhosis: a 52-week phase 2 randomized
clinical trial
|
Presenter:
|
Dr. Arun J. Sanyal, MD,
Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic
Health, Virginia Commonwealth University
|
Session
Title:
|
Late Breaker
|
Session Date and
Time:
|
Saturday, 8 June, 14:00
- 15:30 CEST
|
Presentation
Time:
|
15.15 CEST
|
Location
|
Gold Room
|
Abstract
Number:
|
LP139
|
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
patients with cirrhosis including improvements in sarcopenia and
quality of life, prevention or reduction in the occurrence of
decompensation events such as HE, and improvement in post liver
transplant outcomes, survival, 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 partnerships. 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, LPCN
2203 an oral candidate targeted for the management of essential
tremor, LPCN 2401 an oral proprietary combination of anabolic
androgen receptor agonist and α-tocopherol, an antioxidant, as an
adjunct therapy to incretin mimetics as an aid for improved body
composition in chronic weight management and LPCN 1148, a novel
androgen receptor agonist prodrug for oral administration targeted
for the management of symptoms associated with liver cirrhosis
including prevention of the recurrence of overt hepatic
encephalopathy. Lipocine is exploring partnering opportunities
for LPCN 1107, our candidate for prevention of preterm birth, LPCN
1154, for rapid relief of postpartum depression, LPCN 1148, for the
management of decompensated cirrhosis, LPCN 2401 for obesity
management 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, the
potential uses and benefits of our product candidates, the
potential uses and benefits of LPCN 1148, and the timing of and our
ability to make any NDA filing relating to LPCN 1148, our
development of and filing of an 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.