SALT LAKE CITY, March 1, 2022 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused
on neuroendocrine and metabolic disorders, today provided an update
from the Type C guidance meeting with the U.S. Food and Drug
Administration ("FDA") regarding the development path for LPCN
1144. LPCN 1144 is targeted for treatment for nonalcoholic
steatohepatitis (NASH) in non-cirrhotic men. NASH is a more
advanced state of non-alcoholic fatty liver disease ("NAFLD") and
can progress to a cirrhotic liver or liver failure, require liver
transplant, and can result in hepatocellular carcinoma/liver
cancer, and can lead to death.
The FDA provided a written response in which it acknowledged
that the New Drug Application ("NDA") submission of LPCN 1144 would
be via 505(b)2 regulatory pathway. The FDA also agreed that no
additional nonclinical studies are needed to support a 505(b)(2)
NDA submission for LPCN 1144.
The FDA acknowledged that in the phase 2 study completed by
Lipocine to evaluate LPCN 1144 in NASH (the "Liver Fat
intervention with oral Testosterone" or LiFT study,
NCT04134091), subjects achieved improvements in key components
associated with NASH histopathology after 36-weeks of treatment
with LPCN 1144 in adult males. The FDA agreed that the proposed
multicomponent primary surrogate endpoint is acceptable for seeking
approval under the accelerated approval pathway.
The FDA has recommended Lipocine either conduct a separate
dose-ranging study prior to phase 3 or evaluate multiple doses in
the phase 3 study. The multicomponent primary surrogate endpoint
proposed to FDA by Lipocine is acceptable for seeking approval
under the accelerated approval pathway and FDA recommended a phase
3 study duration of 72 weeks. The FDA has requested that
Lipocine submit an updated phase 3 protocol for FDA feedback on the
study design and recommended requesting an end-of-phase 2 meeting
to discuss the phase 3 and confirmatory trial designs, including
the plan for reading liver histopathology.
"We are pleased to have achieved alignment with
the FDA on key elements of a development plan for LPCN
1144 in non-cirrhotic NASH." said Dr. Mahesh Patel, Chairman,
President, and Chief Executive Officer of Lipocine. "We plan to
submit an updated phase 3 protocol to the FDA for its
review."
About Lipocine
Lipocine Inc. is a clinical-stage biopharmaceutical company focused
on metabolic and endocrine disorders using its proprietary drug
delivery technologies. Lipocine's development pipeline includes:
TLANDO®, LPCN 1111, LPCN 1144, LPCN 1148, LPCN 1107 and oral
neurosteroids. 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 1111, 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, LPCN 1111 met the typical primary and secondary endpoints.
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. LPCN 1148 is an oral
prodrug of bioidentical testosterone targeted for the management of
symptoms associated with liver cirrhosis. 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 of completion of clinical trials, the timing and
completion of regulatory reviews, outcomes of clinical trials of
our product candidates, the potential uses and benefits of our
product candidates, and our product development efforts. Investors
are cautioned that all such forward-looking statements involve
risks and uncertainties, including, without limitation, the risks
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. 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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SOURCE Lipocine Inc.