SALT
LAKE CITY, Nov. 18, 2024 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery, today announced the publication and
discussion of a manuscript "Oral LPCN 1148 Improves Sarcopenia
and Hepatic Encephalopathy in Male Patients with Cirrhosis: a
randomized, placebo-controlled Phase 2 trial" in the journal
Hepatology and discussion at The Liver Meeting (AASLD) 2024
Editor's Cut: Clinical Study Session held on November 16, 2024. LPCN 1148 is targeted to be a
"First in Class" product candidate with a novel mechanism of action
for overt hepatic encephalopathy and sarcopenia indications. A copy
of the publication can be accessed here.
The publication features the results from a Phase 2
proof-of-concept clinical trial (LPCN 1148-21-001) that evaluated
LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver
transplantation. The trial was conducted in two stages. Stage 1 was
double blind, placebo-controlled with participants randomized 1:1,
to receive either oral LPCN 1148 or placebo. This was followed by
Stage 2, a 28-week single-arm open label extension. The publication
reports the analyses from the Stage 1 readout.
The results at 24 weeks showed that LPCN 1148 therapy resulted
in a significant improvement in sarcopenia when compared with
placebo. Furthermore, despite most participants already on
background therapies for HE, participants receiving LPCN 1148 also
experienced significantly fewer episodes of overt
hepatic encephalopathy (OHE) compared to those on placebo.
Additional beneficial effects of LPCN 1148, including improved
muscle quality, hemoglobin, and patient reported symptom
improvement are also covered in the manuscript.
The publication was discussed at The Liver Meeting during 'The
Editors Cut: Clinical Studies' session. This session critically
discusses the most notable, influential, cutting edge, game
changing clinical research papers published during the past
year.
"We are pleased to publish the results from this important
proof-of-concept study of LPCN 1148 in Hepatology, a leading
peer-reviewed journal," said Benjamin
Bruno, Ph.D., Pharm.D., Vice President of Clinical
Development at Lipocine and lead author on the publication. "To our
knowledge, LPCN 1148 therapy is the first pharmacologic agent to
demonstrate improvements in both sarcopenia and overt HE outcomes
in patients with cirrhosis. Our findings support further research
on the efficacy of LPCN 1148 in managing cirrhosis complications, a
critical unmet medical need."
For more information on the study, refer to ClinicalTrials.gov
NCT04874350.
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 OHE
OHE 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 OHE.
OHE is an episodic neurological disorder with a high recurrence
rate. Up to 50% of patients with cirrhosis will experience
an OHE 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 OHE is ~50%. Furthermore, cognitive impairment
associated with cirrhosis results in utilization of more health
care resources.
About LPCN 1148
LPCN 1148 comprises testosterone dodecanoate, a unique androgen
receptor agonist. It is targeted as a differentiated intervention
option with a novel multimodal MOA to elicit potential benefits in
management of cirrhosis and associated comorbidities of
cirrhosis.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop differentiated products.
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 anabolic androgen receptor
agonist, as an adjunct therapy to incretin mimetics, as an aid for
improved body composition in obesity management and LPCN 1148, a
novel androgen receptor agonist prodrug for oral administration
targeted for the management of symptoms associated with liver
cirrhosis. Lipocine is exploring partnering opportunities for LPCN
1107, our candidate for prevention of preterm birth, LPCN 1154, for
rapid relief of postpartum depression, LPCN 2401 for obesity
management, LPCN 1148, for the management of decompensated
cirrhosis, 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 development and commercialization of
TLANDO and TLANDO XR (LPCN 1111) by our licensees, the amount of
the license fee, milestone payments, and royalty payments we will
ultimately receive, the ability of our licensees to grow the TLANDO
franchise, our product development efforts, the application of our
proprietary platform in developing new treatments for CNS
disorders, our product candidates and related clinical trials, our
development of our product candidates and related efforts with the
FDA, including with respect to LPCN 1148 and LPCN 2401, the timing
of our submission of a 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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