Exhibit
99.1
Lipocine
Announces First Cohort Dosed in Pivotal Study of LPCN 1154
Company
anticipates topline results from this crossover pivotal study late in the second quarter of 2024
SALT
LAKE CITY, March 25, 2024 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central
Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first
cohort of subjects has been dosed in pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154.
LPCN 1154, oral brexanolone, is being developed by Lipocine for the treatment of postpartum depression (PPD).
The
pivotal PK study is an open label, randomized, crossover study in 24 healthy postmenopausal women utilizing the “to be marketed”
formulation of LPCN 1154 and dosing regimen. The primary objective of the study is to compare the pharmacokinetics of a multi-dose regimen
of oral LPCN 1154 to IV infusion brexanolone administered per label instructions. During the two treatment visits, each participant will
receive the oral and IV brexanolone regimens in a randomized, crossover manner. Safety and tolerability of the multidose regimen of LPCN
1154 will also be evaluated. Consistent with the goal of NDA submission by the end of the fourth quarter of 2024, the company anticipates
topline results from this crossover pivotal study late in the second quarter of 2024.
PPD
is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting for up to
12 months after childbirth. There is an unmet need for an oral fast-acting product with an improved efficacy and safety profile to treat
PPD. Oral LPCN 1154, comprising a bioidentical neuroactive steroid with 48-hour outpatient dosing, is being developed to provide rapid
relief with robust efficacy.
Recent
reports suggest that the market size for PPD is larger than previously estimated. Approximately 500,000 women are affected by PPD annually
in the United States and, according to the CDC, an estimated 175,000 women suffer from moderate to severe PPD. Increasing awareness of
PPD among physicians and patients is expected to result in higher diagnosis rates and greater numbers of patients seeking treatment.
Lipocine
has confirmed with the U.S. Food and Drug Administration (FDA) acceptance of a proposal for a 505(b)(2) NDA filing based on a single
pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone.
“It
is encouraging to see that awareness of this serious condition is growing,” said Dr. Mahesh Patel, President and CEO of Lipocine.
“LPCN 1154 is targeted to be a highly effective, oral, fast-acting and short duration treatment option for PPD, a serious and potentially
life-threatening condition. We believe a 48-hour oral dosing duration will be important for patients and caregivers. If approved, LPCN
1154 has the potential to be a differentiated preferred treatment option for PPD.”
About
LPCN 1154
LPCN
1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of postpartum depression
(PPD). Brexanolone is a bioidentical to naturally occurring neuro active steroid, allopregnanolone, a positive allosteric modulator of
y-aminobutyric acid (GABA) receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with
severe PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse
reactions to breastfed infants from exposure to brexanolone.
About
Postpartum Depression and Unmet Needs:
PPD
is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12
months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include
hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia,
sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of
death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately
20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants
for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as sexual dysfunction and weight
gain, and do not demonstrate adequate remission post-acute treatment.
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 partnering. 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, LCPN 2203 for essential tremor 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, LPCN1154, for rapid relief of postpartum depression, 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 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 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.
SOURCE
Lipocine Inc.
For
further information:
Krista
Fogarty
Phone:
(801) 994-7383
kf@lipocine.com
Investors:
PJ
Kelleher
Phone:
(617) 430-7579
pkelleher@lifesciadvisors.com
