SALT LAKE CITY, June 23, 2021 /PRNewswire/ -- Lipocine Inc.
(Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused
on metabolic and endocrine disorders, today announced that clinical
data will be presented at The International Liver Congress™ 2021,
the annual meeting of the European Association for the Study of the
Liver ("EASL"), Digital Event, on June
23-26, 2021.
1. Title: Oral LPCN 1144 treatment significantly reduced
liver fat and key liver injury markers in biopsy confirmed NASH
subjects: Results of a Phase 2 randomized controlled study Low
Testosterone in Males may Warrant Liver Health Assessment
Intervention
Session Type: Poster Session
Category: NAFLD: Therapy
Date: June 23, 2021 8:00 a.m.
E.T. to 6:00 p.m. C.E.T
ePoster Session: June 25, 2021 11:30 a.m. C.E.T.
2. Title: High prevalence of low normal or overtly
hypogonadal levels of testosterone observed in histologically
established NASH subjects in LiFT Study
Session Type: Poster Session
Category: NAFLD: Therapy
Date: June 23, 2021 8:00 a.m.
E.T. to 6:00 p.m. C.E.T
3. Title: LPCN 1144 improves body composition in
biopsy-confirmed NASH patients
Session Type: Poster Session
Category: Late Breaker: General Hepatology
Date: June 23, 2021 8:00 a.m.
E.T. to 6:00 p.m. C.E.T
About Lipocine
Lipocine Inc. is a clinical-stage
biopharmaceutical company focused on metabolic and endocrine
disorders using its proprietary drug delivery technologies.
Lipocine's clinical development pipeline includes: TLANDO, LPCN
1144, TLANDO XR, LPCN 1148, LPCN 1154 and LPCN 1107. TLANDO, a
novel oral prodrug of testosterone containing testosterone
undecanoate, has received tentative approval from the FDA for
conditions associated with a deficiency of endogenous testosterone,
also known as hypogonadism, in adult males. LPCN 1144, an oral
prodrug of bioidentical testosterone, recently completed a
proof-of-concept clinical study demonstrating the potential utility
in the treatment of non-cirrhotic NASH. LPCN 1144 is currently
being studied in a Phase 2 clinical study. TLANDO XR, a novel
oral prodrug of testosterone, originated and is being developed by
Lipocine as a next-generation oral testosterone product with
potential for once-daily dosing. In a phase 2 clinical evaluation
when administered as once daily or twice daily TLANDO XR met the
typical primary and secondary end points. LPCN 1148 is an oral
prodrug of bioidentical testosterone targeted for the treatment of
cirrhosis. LPCN 1154 is an oral neurosteroid targeted for the
treatment of depressive disorders. LPCN 1107 is potentially the
first oral hydroxyprogesterone caproate product candidate indicated
for the prevention of recurrent preterm birth and has been granted
orphan drug designation by the FDA. 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 timing of completion of clinical trials and studies,
the availability of additional data, 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 risk
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.