Liposyn reports top-line safety and efficacy results for LPCN 1154 in patients with postpartum depression

• In a phase 3 study population of patients with PPD (N = 90), LPCN 1154 did not demonstrate a statistically significant reduction from baseline in the HAM-D17 total score at 60 hours (primary endpoint) compared to placebo. The primary endpoint was not met

• In a post hoc analysis of participants (n = 54) with a history of psychiatric illness, LPCN 1154 demonstrated statistically significant and clinically meaningful reductions in HAM-D scores compared to placebo starting at 12 hours and continuing through day 30.

• In the overall population, LPCN 1154 was well tolerated and demonstrated a differential safety profile with no adverse events reported, including somnolence or headache, occurring in more than 5% of LPCN 1154-treated participants.

• The company plans to evaluate all available options in the future

Salt Lake City, April 2, 2026 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 (Postpress Part Oral Brixanolone Therapy). For more information about the trial design, visit clinicaltrials.gov: NCT06979544.

LPCN 1154 did not demonstrate a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and primaries were not met. Results indicated that LPCN 1154 was well tolerated and demonstrated a suitable safety profile to support outpatient administration without the need for healthcare provider monitoring. No serious or serious adverse events (SAEs) related to treatment were reported; No cases of severe unconsciousness or loss of consciousness were observed; and no treatment-related discontinuations were reported.

In a post-hoc analysis of participants with a history of psychiatric conditions diagnosed using the Mini-International Neuropsychiatric Interview (MINI, a structured diagnostic interview used to screen and diagnose psychiatric disorders using DSM/ICD criteria), the company identified signs that could indicate a potential development pathway for L154PC.

Table: Placebo-adjusted HAM-D17 score change from baseline

NSS: Not statistically significant. Mixed model for repeated measures, least square mean placebo-adjusted difference. P-values ​​are nominal without the total population at 60 hours.

Based on the results of a post-hoc analysis of efficacy among participants with a history of a psychiatric condition based on the MINI, the company applied for breakthrough treatment and fast-tracking designs for LPCN 1154 in patients with PPD. While the company awaits feedback from the FDA on such designs, the company plans to secure capital and engage with stakeholders, including investors, regulators, and consultants, to evaluate all options available to the company. Such options may include, but are not limited to, the continued development of LPCN 1154, including the potential submission of validation study protocols, development of other product candidates, strategic transactions, partnerships, and other opportunities.

The company intends to complete a full analysis of the trial data in the coming weeks and plans to present the results at future conferences. The company thanks the patients, investigators, and site staff for their contributions.

regarding to LPCN 1154

LPCN 1154 is an oral formulation of brexanolone developed to provide rapid relief of postpartum depression in a convenient home remedy. It has potential as a first-line treatment option for women with PPD. It also has features that are particularly useful for patients with severe PPD (including those at high risk of suicide) for whom rapid improvement is a priority. LPCN 1154 is expected to present a safe safety profile for breastfeeding mothers.

On postpartum depression and unmet needs

PPD is a major anxiety disorder that begins during pregnancy or within four weeks of giving birth, and symptoms last up to 12 months after the baby is born. Hormonal changes that cause GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include symptoms of major depression, including, but not limited to, depression, depressed mood, loss of interest, appetite changes, insomnia, excessive sleeping, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming child/self, and/or thoughts of death or suicide. Results of a recent survey (Truist Securities Research, January 2024) indicate that obstetricians believe that approximately 20-40% of their patients may be suffering from PPD. In addition, obstetricians are comfortable diagnosing and prescribing antidepressants for PPD. Conventional antidepressants, which are not approved for PPD, have a slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission.

About Liposyn

Liposyn is a biopharmaceutical company that leverages its proprietary technology platform to develop innovative products with effective oral delivery. Liposyn has drug candidates in development as well as drug candidates for which we are seeking partnerships. Our drug candidates represent the potential of a variety of patient-friendly oral delivery options for a tailored benefit to risk profile that target large target markets with significant unmet medical needs.

Liposyn’s development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2202 for the treatment of treatment-resistant depression, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremors, LPCN 2401 for the management of LPCN to improve body composition. 1148 is targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 is our candidate for the prevention of preterm birth. TLANDO, a new oral testosterone prodrug containing liposynin-derived testosterone undecanoate, has been approved by the FDA for conditions associated with endogenous testosterone deficiency in adult males, also known as hypogonadism. For more information, please visit www.lipocine.com.

Visible Statements

This release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Filing Reform Act of 1995 and include statements that are not historical facts about our development of LPCN 1154 and related efforts with the FDA, the potential uses and benefits of LPCN 1154 as a potential therapeutic for LPCN 115D. 1154, and potential strategic opportunities. 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 the development of product candidates, that we may not have sufficient capital to complete the development process for our product candidates or that we decide to allocate our available capital to other product candidates, that we may not be able to enter into other relationships with our partners to ensure the safety and security of our products. Efficacy studies, including those related to LPCN 1154, may not be successful or may not provide results that support NDA submissions, the FDA may not approve any of our products, risks associated with our products, anticipated product benefits are not accepted, clinical and regulatory expectations and plans are not accepted, new regulatory developments and requirements related to the FDA’s review process, including the risk review process. Approvals and our ability to use the regular approval process for LPCN 1154, the results and timing of clinical trials, patient acceptance of Liposyn products, the manufacturing and commercialization of Liposyn products, and other risks described in Liposyn’s filings, without further limitation and reporting to the SECm10. 8-K and 10-Q, all of which can be obtained on the SEC’s website at www.sec.gov. Liposyn undertakes no obligation to publicly update or revise any forward-looking statements contained in this release, except as required by law.

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