SALT LAKE CITY, Nov. 4, 2021 /PRNewswire/ -- Lipocine Inc.
(LPCN), a clinical-stage biopharmaceutical company focused on
metabolic and endocrine disorders, today announced that the
U.S. Food and Drug Administration ("FDA") has granted Fast Track
Designation to LPCN 1144 as a treatment for non-cirrhotic
non-alcoholic steatohepatitis ("NASH"). LPCN 1144, an oral prodrug
of bioidentical testosterone, was recently studied in
the Liver Fat intervention with oral Testosterone
("LiFT ") Phase 2 paired biopsy clinical study in
patients with confirmed NASH. Treatments with LPCN 1144 in
the LiFT clinical study resulted in robust liver fat
reduction, assessed by magnetic resonance imaging, proton density
fat fraction ("MRI-PDFF") technique, and showed improvement of
liver injury markers with no observed tolerability issues.
Additionally, key secondary endpoint results after 36 weeks of
treatment in the LiFT clinical study demonstrated that
treatments with LPCN 1144 met the NASH resolution regulatory
endpoint, showed positive effects in appendicular lean mass and
whole-body fat mass and continued to show substantial reductions in
markers of liver injury compared to placebo.
"The granting of Fast Track Designation represents an important
recognition by the FDA of LPCN 1144's potential to
address a significant unmet need in the treatment of NASH," said
Dr. Mahesh Patel, Chairman,
President and Chief Executive Officer of Lipocine. "We believe the
Fast Track Designation will enable us to work closely with the FDA
on our development program for NASH, including the design of the
Phase 3 program."
The Fast Track program is designed to accelerate the development
and expedite the review of products, such as LPCN 1144, which are
intended to treat serious diseases and for which there is an unmet
medical need. Fast Track designation lends eligibility for
some, or all, of the following:
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval
- More frequent written communication from FDA about such things
as the design of the proposed clinical trials and use of
biomarkers
- Eligibility for Accelerated Approval and Priority Review if
relevant criteria are met
- Rolling Review, which means that a drug company can submit
completed sections of its New Drug Application (NDA) for review by
FDA, rather than waiting until every section of the NDA is
completed before the entire application can be reviewed
About NASH
NASH is a more advanced state of non-alcoholic fatty liver disease
("NAFLD") and can progress to a cirrhotic liver and eventually
hepatocellular carcinoma/liver cancer. Twenty-five to thirty
percent of the U.S. population is estimated to suffer from
NAFLD. NASH afflicts three to twelve percent of the U.S.
population, which is a substantially large population that lacks
effective therapy. Currently, there are no FDA approved treatments
for NASH. Approximately 50% of NASH patients are in adult males and
the number of NASH cases is projected to increase 63% from 16.5
million cases in 2015 to 27.0 million cases in 2030. NAFLD/NASH is
becoming more common due to its strong correlation with obesity and
metabolic syndrome, including components of metabolic syndrome such
as diabetes, cardiovascular disease and high blood pressure. In
men, especially with comorbidities associated with NAFLD/NASH,
testosterone deficiency has been associated with an increased
accumulation of visceral adipose tissue and insulin resistance,
which could be factors contributing to NAFLD/NASH.
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 the 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 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 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.
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 1144 for the treatment of NASH, the timing of additional data,
our ability to take advantage of the benefits of Fast Track
Designation for LPCN 1144,whether LPCN 1144 will receive
accelerated approval from the FDA for LPCN 1144, 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.
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SOURCE Lipocine Inc.