SALT
LAKE CITY, June 10, 2024 /PRNewswire/
-- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company,
today announced that Phase 2 results on LPCN 1148 in cirrhosis were
featured in a late breaking oral presentation at the European
Association for the Study of Liver (EASL) Congress on
Saturday, June 8, in Milan, Italy. The presentation
"Intervention with oral LPCN 1148 improves sarcopenia and
hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week
phase 2 randomized clinical trial" was presented by
Arun J. Sanyal, MD, Director,
Stravitz-Sanyal Institute for Liver Disease and Metabolic Health,
Virginia Commonwealth University. The
presentation is featured in the symposium "Revolutionary Advances
in Liver Disease Research Unveiled at EASL Congress 2024"
(https://www.hepmag.com/article/revolutionary-advances-liver-disease-research-unveiled-easl-congress-2024)
highlighting significant advances in liver disease.
A copy of Dr. Sanyal's presentation delivered at EASL Congress
2024 can be found on the Lipocine corporate website here.
www.lipocine.com
About Cirrhosis
Cirrhosis is an end stage liver disease of varying etiologies
such as alcoholic liver disease, chronic viral hepatitis,
nonalcoholic fatty liver disease and primary cholangitis.
Complications of cirrhosis include decompensation events such as
hepatic encephalopathy due to systemic ammonia buildup,
variceal bleeding, and ascites, which require frequent
hospitalizations. In addition, many patients
exhibit sarcopenia (low muscle mass).
Over 382,000 patients have been diagnosed with decompensated
liver cirrhosis in the US, with few options for managing their
disease other than liver transplant. Poor quality of life is common
while waiting for a liver transplant. Although there is a limited
supply of donor livers, transplant is the only cure for end-stage
cirrhosis.
About HE
HE is a frequent complication and one of the most debilitating
manifestations of liver disease, severely affecting the lives of
patients and their caregivers. For patients with decompensated
liver cirrhosis and sarcopenia, clinical outcomes tend to be worse
- both sarcopenia and myosteatosis are associated with an increased
risk of HE.
HE is an episodic neurological disorder with a high recurrence
rate. Up to 50% of patients with cirrhosis will experience
an HE episode in their lifetime. Patients can exhibit global
neurological, psychiatric, and musculoskeletal deficits. HE
has a complex pathophysiology that includes impairment of
ammonia clearance and increased inflammatory cytokine and HE
recurrence is common, despite use of standard-of-care therapies.
Options for prevention/treatment are limited, resulting in
significant enduring unmet medical need as the 1-year survival for
patients with HE is ~50%. Furthermore, cognitive impairment
associated with cirrhosis results in utilization of more health
care resources.
About the Phase 2 study
This multi-center study enrolled and dosed a total of 29
patients across 8 centers in the United States. The primary objective was to
evaluate the efficacy of 24 weeks of LPCN 1148 treatment in
men with cirrhosis and sarcopenia. The secondary objective was to
evaluate the safety and tolerability of LPCN 1148. Following
Week 24, the open-label stage of the study began (Stage 2), wherein
all participants received LPCN 1148 (no placebo in Stage 2).
Baseline characteristics, including age, disease etiology
baseline L3-SMI, and other comorbidities were generally
well-balanced between groups. Overall, the average baseline Model
for End-Stage Liver Disease (MELD) score was 16.8, and 97% of
patients had previously experienced at least one clinical
decompensation event. Sarcopenia, or low muscle mass, was
assessed by computed tomography (CT) scan; total skeletal muscle
area at the third lumbar vertebra was measured by CT scan and
normalized by participant height (L3-SMI, L3-skeletal muscle
index). Patients had study visits every four weeks, with CTs
performed at Weeks 12, 24, 36, and 52. Patients with a variety of
cirrhosis etiologies were eligible. During the study there were no
restrictions on standard of care medications, procedures, or other
interventions. Further details on the study design, including
inclusion and exclusion criteria, can be found
on Clinicaltrials.gov (NCT04874350).
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 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 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, LPC 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, 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.
SOURCE Lipocine Inc.
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SOURCE Lipocine Inc.