SALT
LAKE CITY, June 6, 2022 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a biopharmaceutical company focused on developing
innovative products for neuroendocrine and metabolic disorders,
presented "LPCN 2101: An Endogenous Neuroactive Steroid for
Epilepsy" today at the 2022 Epilepsy Foundation Pipeline
Conference. The conference is held every two years to bring
together decision-makers in the field of epilepsy treatment,
therapeutic innovation and development, showcasing the latest
developments in the epilepsy pipeline. This forum provides an
opportunity for evaluating new therapies in development, exploring
future advancements, and encouraging collaborations and
partnerships.
"We are excited to have been invited to present at this
important event," commented Dr. Patel. "Given the unique needs of
Women With Epilepsy (WWE) and the limitations of currently
available treatment options, we look forward to advancing our novel
oral positive GABAA modulator for WWE of child bearing
(CB) age."
Pending U.S. FDA clearance of its IND, Lipocine plans to conduct
a proof-of-concept study in the second half of 2022.
About Epilepsy
Epilepsy is a disorder of the brain
that causes seizures, affecting the physical, mental, and social
well-being of persons, and is associated with a 2 to 3 times
greater mortality rate compared with the general population.
About 60-65% of epilepsy is idiopathic and about 30% of patients
are refractory. Epilepsy is the most common neurological disorder
during pregnancy.
It is estimated that approximately 900,000 CB age women suffer
from active epilepsy in the U.S. Women of CB age with epilepsy face
many additional challenges due to hormonal influences on seizure
activity and endocrine function throughout the different phases of
their reproductive cycles. Elevated estrogen or decreased
progesterone levels can exacerbate seizure frequency. Often, these
women experience hormonal and endogenous NAS imbalances, coupled
with fluctuations in the blood levels of anti-epileptic drugs that
impact control of seizures, efficacy of oral contraceptives, any
coexisting anxiety and/or depression and any associated sleep
impairment.
About Lipocine
Lipocine Inc. is a biopharmaceutical
company focused on neuroendocrine and metabolic disorders using its
proprietary drug delivery technologies. Lipocine's clinical
development pipeline includes: LPCN 1148, LPCN 1144, LPCN 1111,
LPCN 1107 and oral neuroactive steroids including LPCN 1154 and
LPCN 2101. TLANDO, a novel oral prodrug of testosterone containing
testosterone undecanoate, is approved by the FDA for conditions
associated with a deficiency of endogenous testosterone, also known
as hypogonadism, in adult males. LPCN 1148 is an oral prodrug
of bioidentical testosterone targeted for the management of
symptoms associated with liver cirrhosis. 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 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 primary and
secondary endpoints. 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. Neuroactive steroids are
currently being evaluated including LPCN 1154 for the potential
treatment of postpartum depression and LPCN 2101 for the potential
treatment of epilepsy. 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.