Lipocine Announces Initiation of Outpatient Phase 3 Postpartum Depression Trial of LPCN 1154
Lipocine (NASDAQ: LPCN) has initiated a Phase 3 trial for LPCN 1154 (oral brexanolone) for treating postpartum depression (PPD). The registration-enabling trial follows successful pharmacokinetic bridge study results showing comparable exposure between LPCN 1154 and the reference drug.
The trial design features a two-arm, randomized, blinded study comparing LPCN 1154 to placebo in women aged 15 and older with severe PPD. Key aspects include:
- 48-hour at-home self-administration dosing period
- First patient dosing expected in Q2/2025
- Primary endpoint: Change from baseline in Hamilton Depression Rating Scale (HAM-D)
- Secondary endpoints: Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Rating Scale (HAM-A)
The trial aims to support a global registration package for LPCN 1154, potentially positioning it as a first-line option for rapid PPD symptom relief.
Lipocine (NASDAQ: LPCN) ha avviato uno studio di Fase 3 per LPCN 1154 (brexanolone orale) per il trattamento della depressione postpartum (PPD). Lo studio, che consente la registrazione, segue i risultati di uno studio ponte farmacocinetico di successo che ha mostrato un'esposizione comparabile tra LPCN 1154 e il farmaco di riferimento.
Il disegno dello studio prevede un studio randomizzato, in doppio cieco con due bracci che confronta LPCN 1154 con un placebo in donne di età pari o superiore a 15 anni con PPD grave. Gli aspetti chiave includono:
- Periodo di somministrazione domiciliare di 48 ore
- Primo dosaggio previsto nel secondo trimestre del 2025
- Obiettivo primario: Variazione rispetto al basale nella Hamilton Depression Rating Scale (HAM-D)
- Obiettivi secondari: Variazioni nella Montgomery-Åsberg Depression Rating Scale (MADRS) e nella Hamilton Anxiety Rating Scale (HAM-A)
Lo studio mira a supportare un pacchetto di registrazione globale per LPCN 1154, posizionandolo potenzialmente come opzione di prima linea per un rapido sollievo dai sintomi della PPD.
Lipocine (NASDAQ: LPCN) ha iniciado un ensayo de Fase 3 para LPCN 1154 (brexanolona oral) para tratar la depresión posparto (PPD). El ensayo que habilita la inscripción sigue a los resultados exitosos de un estudio puente farmacocinético que muestra una exposición comparable entre LPCN 1154 y el fármaco de referencia.
El diseño del ensayo presenta un estudio aleatorizado, doble ciego y de dos brazos que compara LPCN 1154 con un placebo en mujeres de 15 años o más con PPD severa. Los aspectos clave incluyen:
- Período de auto-administración en casa de 48 horas
- Se espera que la primera dosis se administre en el segundo trimestre de 2025
- Punto final primario: Cambio desde la línea base en la Escala de Calificación de Depresión de Hamilton (HAM-D)
- Puntos finales secundarios: Cambios en la Escala de Calificación de Depresión de Montgomery-Åsberg (MADRS) y en la Escala de Calificación de Ansiedad de Hamilton (HAM-A)
El ensayo tiene como objetivo apoyar un paquete de registro global para LPCN 1154, posicionándolo potencialmente como una opción de primera línea para un alivio rápido de los síntomas de PPD.
리포신 (NASDAQ: LPCN)은 산후 우울증 (PPD) 치료를 위한 LPCN 1154 (경구용 브렉사놀론)의 3상 시험을 시작했습니다. 등록을 위한 이 시험은 LPCN 1154와 기준 약물 간의 유사한 노출을 보여주는 성공적인 약리학적 교량 연구 결과를 따릅니다.
시험 설계는 심각한 PPD를 앓고 있는 15세 이상의 여성에서 LPCN 1154와 위약을 비교하는 두 팔, 무작위, 이중 맹검 연구를 특징으로 합니다. 주요 사항은 다음과 같습니다:
- 48시간 자가 투여 기간
- 첫 환자 투여는 2025년 2분기에 예상됨
- 주요 목표: 해밀턴 우울증 평가 척도 (HAM-D) 기준선 변화
- 부차적 목표: 몽고메리-아스버그 우울증 평가 척도 (MADRS) 및 해밀턴 불안 평가 척도 (HAM-A) 변화
이 시험은 LPCN 1154의 글로벌 등록 패키지를 지원하는 것을 목표로 하며, PPD 증상 완화를 위한 1차 옵션으로 자리매김할 수 있습니다.
Lipocine (NASDAQ: LPCN) a lancé un essai de Phase 3 pour LPCN 1154 (brexanolone oral) afin de traiter la dépression postpartum (PPD). L'essai, qui permet l'enregistrement, fait suite à des résultats positifs d'une étude de pont pharmacocinétique montrant une exposition comparable entre LPCN 1154 et le médicament de référence.
Le design de l'essai comprend une étude randomisée, en double aveugle à deux bras comparant LPCN 1154 à un placebo chez des femmes de 15 ans et plus souffrant de PPD sévère. Les aspects clés incluent :
- Période d'auto-administration à domicile de 48 heures
- La première administration de patient est prévue pour le deuxième trimestre de 2025
- Critère principal : Changement par rapport à la ligne de base sur l'échelle d'évaluation de la dépression de Hamilton (HAM-D)
- Critères secondaires : Changements dans l'échelle d'évaluation de la dépression de Montgomery-Åsberg (MADRS) et dans l'échelle d'évaluation de l'anxiété de Hamilton (HAM-A)
L'essai vise à soutenir un paquet d'enregistrement mondial pour LPCN 1154, le positionnant potentiellement comme une option de première ligne pour un soulagement rapide des symptômes de la PPD.
Lipocine (NASDAQ: LPCN) hat eine Phase-3-Studie für LPCN 1154 (orales Brexanolon) zur Behandlung der postpartalen Depression (PPD) gestartet. Die zur Registrierung erforderliche Studie folgt auf erfolgreiche Ergebnisse einer pharmakokinetischen Brückenstudie, die eine vergleichbare Exposition zwischen LPCN 1154 und dem Referenzarzneimittel zeigt.
Das Studiendesign umfasst eine zweiarmige, randomisierte, doppelblinde Studie, die LPCN 1154 mit einem Placebo bei Frauen ab 15 Jahren mit schwerer PPD vergleicht. Zu den wichtigsten Aspekten gehören:
- 48-stündiger Selbstverabreichungszeitraum zu Hause
- Erste Patientendosierung wird im 2. Quartal 2025 erwartet
- Primärer Endpunkt: Veränderung vom Ausgangswert in der Hamilton Depression Rating Scale (HAM-D)
- Sekundäre Endpunkte: Veränderungen in der Montgomery-Åsberg Depression Rating Scale (MADRS) und in der Hamilton Anxiety Rating Scale (HAM-A)
Die Studie zielt darauf ab, ein globales Registrierungspaket für LPCN 1154 zu unterstützen, das es potenziell als Erstlinientherapie für eine schnelle Linderung der PPD-Symptome positioniert.
- FDA approved protocol for at-home self-administration, improving patient convenience
- Successful PK bridge study showing comparable exposure to reference drug
- Trial designed to support global registration package
- Phase 3 trial results not expected until after Q2 2025
- No guaranteed success in Phase 3 trials despite positive PK study results
Insights
Lipocine's initiation of a registration-enabling Phase 3 trial for LPCN 1154 (oral brexanolone) marks a critical milestone in their PPD development program. The advancement follows a successful pharmacokinetic bridge study showing comparable exposure between LPCN 1154 and the reference drug (likely injectable brexanolone/Zulresso).
The trial design contains several noteworthy elements. First, the outpatient, self-administered approach represents a potential paradigm shift from the current standard treatment which requires hospitalization and continuous IV administration over 60 hours. This at-home administration protocol could dramatically improve treatment accessibility and patient convenience if approved. Second, the 48-hour dosing regimen maintains consistency with their PK bridge study, suggesting confidence in their approach.
The primary endpoint utilizing HAM-D (Hamilton Depression Rating Scale) is appropriate and aligned with regulatory expectations for PPD trials. Secondary endpoints including MADRS and HAM-A will provide comprehensive assessment of both depressive and anxiety symptoms. The company's statement that the trial is "powered based on the treatment effect observed with FDA approved injectable brexanolone" indicates they've designed the study with sufficient statistical power to detect clinically meaningful effects.
This Phase 3 trial initiation signifies substantial derisking in LPCN 1154's development pathway, bringing the company closer to potential commercialization of what could be the first oral treatment specifically approved for PPD.
The initiation of this Phase 3 trial positions Lipocine to potentially address significant unmet needs in the PPD treatment landscape. The current gold standard treatment for PPD requires hospitalization with continuous 60-hour IV administration, creating substantial barriers to care including facility availability, high costs, and disruption to mother-infant bonding.
An oral, at-home treatment would represent a major competitive advantage if approved with comparable efficacy. The outpatient approach could dramatically expand patient access while reducing healthcare system burden and costs associated with inpatient administration. For a small-cap company (
The timing is notable - with first patient dosing expected in Q2/2025, Lipocine has established a clear near-term milestone for investors to monitor. However, this also indicates results and potential approval remain on a timeline measured in years rather than quarters.
The CEO's statement positioning LPCN 1154 as a potential "first line option for rapid symptom relief" signals confidence in competitive differentiation. If successful, an oral formulation could substantially expand the addressable market beyond what's currently served by injectable options.
This trial initiation represents meaningful progression in Lipocine's development pipeline, bringing them closer to potentially commercializing a novel treatment option in the PPD space with significant advantages over existing therapies.
- 48 hour at-home dosing
- Patient dosing expected in Q2/2025
Based on observed comparable exposure of LPCN 1154 and the reference drug established in the pharmacokinetic (PK) bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025. This randomized, blinded, placebo controlled study is designed to evaluate safety and efficacy of LPCN 1154 in women with PPD. This outpatient trial is expected to support a global registration package for LPCN 1154 in PPD.
"We are excited to initiate this registration-enabling Phase 3 trial," said Mahesh Patel, CEO of Lipocine. "Importantly, based on FDA protocol feedback, patients will self-administer LPCN 1154 at home. We believe that LPCN 1154 has the potential to be the first line option for rapid symptom relief in women with PPD."
Trial Design
The trial is a two-arm, randomized, blinded study comparing LPCN 1154 to placebo in women aged 15 years and older, diagnosed with severe postpartum depression (PPD). The treatment regimen involves a 48-hour dosing period, consistent with the dosing in Lipocine's PK bridge study.
The primary endpoint 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-Åsberg 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.
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. Brexanolone is a bioidentical to naturally occurring neuroactive 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
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. 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.
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, 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 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 candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our P3 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.
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SOURCE Lipocine Inc.
FAQ
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