Full Press Release Details
Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression
3 Top Line Results Expected Q2 2026
LAKE CITY, June 26, 2025 - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform
to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase
3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum depression (PPD).
FDA feedback, this study is being conducted in an outpatient setting, with no requirement for medical monitoring by a healthcare provider.
The Company anticipates using the data from this Phase 3 trial to support an NDA submission of LPCN 1154 for PPD in mid-2026.
trial is a two-arm, randomized, blinded study evaluating LPCN 1154 compared to placebo in women aged 15 years and older with severe PPD.
The treatment regimen involves a 48-hour dosing period which was informed by the dosing in Lipocine's successful PK bio-bridge
study with injectable brexanolone. The study is being conducted at multiple clinical sites across the U.S.
primary endpoint of the trial is the change from baseline in the Hamilton Depression Rating Scale (HAM-D), a widely recognized clinical
measure of depression severity. Additional secondary endpoints include the change from baseline in the Montgomery- sberg Depression
Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) to assess anxiety symptoms, as well as key safety and tolerability
measures. The trial size is powered based on the treatment effect observed with the FDA approved injectable brexanolone. Brexanolone
is a bioidentical to naturally occurring neuroactive steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid
(GABA) receptor. For more information, refer to ClinicalTrials.gov ID NCT06979544.
the unmet need for rapid relief, this Phase 3 trial is an important step in our development program to bring LPCN 1154 to women suffering
from postpartum depression," said Mahesh Patel, CEO of Lipocine. "By offering a novel bioidentical oral treatment with 48-hour
treatment duration and expected robust efficacy, LPCN 1154 is designed to be a differentiated, rapid relief product with the potential
to be the standard of care."
Investor Event on LPCN 1154
will host a virtual research and development (R&D) investor event to discuss LPCN 1154 on Wednesday, July 9, 2025 at 11:00 AM ET.
The event will feature Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York), who will join company
management to discuss the current treatment landscape and unmet needs in PPD. The Company will provide a clinical, regulatory, and development
update, including further details on the Phase 3 trial. To register, click here.
1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. LPCN 1154 is
expected to have characteristics that could be particularly appealing to patients with 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.
Postpartum Depression and Unmet Needs
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 weight gain, and do not demonstrate
adequate remission post-acute treatment.
is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery.
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.
clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101
for the potential treatment of refractory 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 metabolic dysfunction-associated steatohepatitis (MASH). 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
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 candidates and related clinical
trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our Phase 3
safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154,
potential partnering of our product candidates with third parties, 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, we may not have sufficient capital to complete the development processes for
our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into
partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating
to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may 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.
further information: