SALT LAKE CITY, Dec. 22, 2021 /PRNewswire/ -- Lipocine Inc.
(Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused
on metabolic and endocrine disorders, today announced that the
first patient has been dosed in its Phase 2 proof-of-concept
clinical study (NCT04874350) for the management of liver
cirrhosis. The Phase 2 study is a multi-center, randomized,
placebo-controlled 52-week study in sarcopenic cirrhotic patients
that are on the liver transplant list. The primary endpoint is
change from baseline in Skeletal Muscle Index ("SMI") via computed
tomography in LPCN 1148 treated subjects compared to
placebo at week 24, and key secondary endpoints include measures of
frailty (liver frailty index), change in waitlist events,
myosteatosis, rate of hospital admissions, all-cause mortality, and
decompensation events (including all cause and liver related
mortalities and clinically significant worsening) and rates of
breakthrough hepatic encephalopathy. Primary endpoint topline
results are expected in the second half of 2022.
"We are excited to have this Phase 2 study underway as LPCN 1148
targets a serious unmet need with a strong pharmaco-economic
justification as a potential treatment for the management of liver
cirrhosis," said Dr. Mahesh Patel, Chairman, President, and
Chief Executive Officer of Lipocine. "In addition to being a unique
treatment option with a compelling rationale, we plan to apply for
Orphan Drug Designation ("ODD") with LPCN 1148 for regressing
decompensation events including Hepatic Encephalopathy," said Dr.
Patel.
About Liver Cirrhosis: Decompensated liver cirrhosis is
estimated to affect more than 630,000 Americans, with men affected
at twice the rate as women, and results in approximately 45,000
deaths every year. The only cure, liver transplant, has a high
economic burden (~$812,500/transplant). The
hypothalamus-pituitary-gonadal axis is profoundly altered in
advanced cirrhotic patients, leading to endocrine dysfunction.
Testosterone levels fall progressively with increased chronic liver
disease severity. Low testosterone levels, reported in the majority
of male cirrhotic patients, is known to be associated with
increased rates of adverse outcomes including varices in the
gastrointestinal tract with internal bleeding, ascites, major
infections, hepatic decompensation, and worsening of quality of
life while awaiting transplant.
About Compromised Muscle in Cirrhosis: The presence of
sarcopenia (loss of muscle mass/area) in 40-70% of cirrhotic men
and frailty (a state of decreased physiological
reserve/functionality) are associated with increased risk of
hospitalization and hepatic decompensation events, a two-fold
increase in waitlist mortality, and poor post-transplant outcomes.
Moreover, myosteatosis (an excess of fat in muscle tissue) is
recognized to negatively correlate with muscle mass, strength, and
mobility, an increased MELD score, worse median survival, and
higher rates of mortality in cirrhotic patients.
About Hepatic Encephalopathy ("HE"): HE is a
metabolically induced, potentially reversible, functional
disturbance of the brain condition leading to "brain fog" due to
the liver's (primary organ) and muscle's (secondary organ)
inability to eliminate myo/neuro toxic ammonia from the systemic
circulation and is a significant decompensation event associated
with cirrhosis. HE is the most potent risk factor for
hospitalization, accidental trauma, and mortality. Clinically overt
HE is significantly more prevalent in cirrhotic patients with
muscle depletion or decreased muscle strength. Reports suggest low
testosterone and fat-free mass depletion are predictors of HE in
cirrhotic liver transplant candidates.
About LPCN 1148: LPCN 1148 is a novel prodrug of
testosterone, testosterone laurate ("TL"), for oral administration
with compelling potential unique mode of action to improve liver
and muscle function, resulting in improved Quality of Life (QOL)
while awaiting transplant, decreased hospital admissions, and
prevention of progression of decompensation events.
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 Phase 2
clinical study demonstrating potential utility in the treatment of
non-cirrhotic NASH. 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 or twice daily, TLANDO XR met the typical
primary and secondary endpoints. LPCN 1148 is an oral prodrug of
bioidentical testosterone targeted for the management of symptoms
associated with liver cirrhosis. LPCN 1154 is an oral neuro-steroid
targeted for the treatment of post-partum depression. 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.
Cautionary and 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 and completion of additional clinical trials and
studies, the potential uses and benefits of LPCN 1148 for the
management of symptoms associated with liver cirrhosis, the timing
of additional data 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. There can be no
assurance that we will choose, or have the ability, to conduct
further clinical trials with respect to LPCN 1148 and, ultimately,
apply for and receive approval from the FDA to market LPCN 1148 for
the indications described in this press release. 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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