Full Press Release Details
ANNOUNCES patient dosed in its Phase 2 Study with LPCN 1148 for management of liver cirrhosis
LAKE CITY, December 22, 2021 - 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.
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,"
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.
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.
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.
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.
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.
and Forward-Looking Statements
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.
Vice President & Chief Financial Officer