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Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC 0- ∞ Ctrough criterion was met LPCN 1154 was well tolerated with no sedation or somnolence events observed On track for NDA filing, targeted by end of Q4 2024 SALT LAKE CITY, June 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive topline study results demonstrating bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic (PK) study. Lipocine is developing LPCN 1154, oral brexanolone, for the treatment of postpartum depression (PPD). The U.S. Food & Drug Administration (FDA) has agreed with Lipocine's proposal for a 505(b)(2) NDA filing based on a single pivotal PK bridging study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. Intravenous brexanolone is approved based on evidence demonstrating efficacy and safety with two dosing regimens with different maximum infusion rates of either 60 µg/kg/hr (IV60) or 90 µg/kg/hr (IV90). Lipocine is targeting NDA submission by the end of the fourth quarter of 2024. "I'm pleased with the positive outcome of this pivotal study which brings us a step closer to potentially offering a differentiated preferred treatment option for PPD patients in need," said Dr. Mahesh Patel, President and CEO of Lipocine. "PPD is a serious and potentially life-threatening condition. LPCN 1154 is targeted to be a highly effective, oral, fast-acting and short duration treatment option. We believe a 48-hour oral dosing duration with fast onset of efficacy would be an important solution for patients and caregivers." Per published FDA bioequivalence guidance1, the criteria to establish bioequivalence are that Geometric Mean Ratios (GMR) and corresponding 90% confidence intervals (CIs) for AUC0-t, AUC0-∞, and Cmax (key measures of drug exposure) fall within 80% to 125% for test vs reference products. The pivotal PK study was an open label, randomized, crossover study in 24 healthy postmenopausal women utilizing the "to be marketed" formulation and oral dosing regimen of LPCN 1154 and the commercial IV brexanolone formulation using the approved high dose infusion regimen (IV90). The primary objective of the study is to compare the PK of a multi-dose regimen of oral LPCN 1154 (test product) to IV infusion brexanolone (reference product). Twenty-four post-menopausal women were randomized (safety set), and all completed dosing in both study periods. The PK analysis data set includes 23 participants; data from one participant meeting outlier criteria was excluded. PK Comparisons of LPCN 1154 vs. IV90 Brexanolone LPCN 1154 and IV90 brexanolone were bioequivalent based on GMRs and 90% CIs for Cmax, AUC0-∞, and AUC0-t meeting established criteria. As targeted, Ctrough of LPCN 1154 geometric mean was higher than the trough of IV brexanolone (geometric lower 90% CI). LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observed. All events were mild to moderate, and no severe or serious adverse events occurred. Reported study related events were venipuncture site reaction, headache, arthralgia, fatigue, dizziness, low back pain, and pelvic pain and no event was reported by more than two participants. 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 is designed to provide rapid relief with robust efficacy and 48-hour outpatient dosing. 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. 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 20-40% 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. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 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, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in chronic weight 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 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 . 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, 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, 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 risk that we do not ultimately receive FDA approval for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, risks related to 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 . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. 1FDA Guidance, Statistical Approaches to Establishing Bioequivalence December 2022 SOURCE Lipocine Inc.

北京 2024年6月24日 /美通社/ -- 2024年第29届欧洲血液学会年会（EHA）于6月13日至16日在西班牙马德里举行，作为全球血液学领域规模最大的国际学术会议之一，来自全球的领域内专家学者齐聚一堂，分享最新科研成果，共同分享和探讨有关血液学的创新理念及最新的基础与临床研究成果。 陆道培医学团队现场合影 近年来，随着中国临床研究的快速发展，中国在世界血液学舞台上发挥着越来越重要的 作用。今年 共有来自中国专家学者的300余项研究成果入选，展现出中国在血液领域的蓬勃生机。本届会议，陆道培医学团队继续在国际学术舞台上大放异彩，共有10项研究成果（包括1篇口头报告，4篇墙报展示、5篇摘要收录）入选，这无疑是陆道培团队研究实力的一次集中展示。 陆道培医院张弦教授会议现场照片 当地时间6月15日下午17：30，陆道培医院血液科张弦主任口头报告了关于"CD7 CAR-T治疗难治复发急性T淋巴细胞白血病/淋巴母细胞淋巴瘤后的免疫重建"的相关研究成果。该研究首次为R/R T-ALL/LBL患者在接受CD7 CAR-T治疗后的免疫重建和感染情况提供了详实的临床数据，引起与会专家学者的关注和讨论。会场主席Anthony Moorman教授称赞该项研究有很高的学术价值和临床意义，并在会议结束后与张弦主任进行讨论交流。 陆道培医学团队壁报研究展示 陆道培团队代表以口头报告、墙报展示等形式和来自世界各地的血液同道一起交流、分享，相信这些交流分享的收获会给团队未来的临床科研工作，尤其是青年医师的学术研究带来一些启发。我们也希望团队的青年医师珍视与全球尤其是其他先进国家的专家学者进行交流、学习的机会，了解领域内前沿进展，学习他们的宝贵经验和治疗方案，不断精进，未来在各自的工作领域能有所突破。 陆道培医学团队始终坚持以患者为中心，以临床需求为导向，充分发挥自身优势，努力攻坚克难，在中国乃至世界血液病治疗领域取得了非常卓越的成绩，发出了强有力的"道培声音"。未来，我们将继续通过不断地创新和努力，提升诊疗水平，为血液肿瘤患者带来更为精准、高效的治疗方案，推动中国血液病事业的持续发展。 EHA 2024 成果一览 口头报告（ORAL） 摘要号：S119 第一作者：张弦，通讯作者：陆佩华 题目：Immune Reconstitution After CD7 CAR-T Cell Therapy for Refractory/Relapsed Acute T-Lymphoblastic Leukemia/Lymphoblastic Lymphoma(R/R T-ALL/LBL) 摘要号：P1299 第一作者：胥方，通讯作者：卢岳 题目：Comparison of Rabbit Anti-Thymocyte Globulins (ATG-T) and Anti-T-Lymphocyte Globulins (ATLG) in TBI-Based MAC of Alternative Donor HSCT for Patients with Acute Lymphoblastic Leukemia 摘要号：P1313 第一作者：王彤，通讯作者：刘红星 题目：Donor-Derived DEL(20Q) Clone Post Allogeneic Hematopoietic Stem Cell Transplantation may Provide Long-Term Survival Benefits 摘要号：P1324 第一作者：隆靖，通讯作者：魏志杰 题目：Salvage Haploidentical Hematopoietic Cell Transplantation with Unrelated Cord Blood Enhances Survival and Reduces the Incidence of Grade Ⅲ-Ⅳ aGVHD for Non-Remission Acute Myeloid Leukemia 摘要号：P1472 第一作者：曹星玉，通讯作者：陆佩华 题目：CD7 CAR-T Therapy for Patients with T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma Who Relapsed after Hematopoietic Stem Cell Transplantation 论文摘要 摘要号：PB2469 第一作者：朱会丽，通讯作者：魏志杰 题目：Efficacy and Safety Analysis of Azacitidine Therapy after Haploidentical Transplantation for Pediatric Acute Myeloid Leukemia Patients Who were Minimal Residual Disease-Positive before Transplant 摘要号：PB2471 第一作者：李婷，通讯作者：王卉 题目：A Composition of Multi-Markers Can High Efficiently Screen Acute Promyelocytic Leukemia 摘要号：PB3122 第一作者：陈曼，通讯作者：王卉 题目：Research on the Impact of the Immune Environment after G-CSF mobilization of Donors and the Prognosis of Patients After Allo-HSCT 摘要号：PB3150 第一作者：南楠，通讯作者：吴芳 题目：Necessity of Personalized Supplements: Study on the Current Situation of Specific Vitamin Deficiency in Patients Undergoing Hematopoietic Stem Cell Transplantation 摘要号：PB3160 第一作者：李楠楠，通讯作者：张建平 题目：A 3rd Stem Cell Can't Improve the Outcome of OS and GFFS for Adult AA Patients Who Undergoing HID-HSCT 注：上述研究成果按摘要号排序