Methylprednisolone Acetate

DURHAM, N.C. and BEIJING, Sept. 26, 2022 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced top-line results from a Phase 1 study evaluating its long-acting, single-injection therapy, BRII-296, in development for the treatment of postpartum depression (PPD). These data show that a single treatment via intramuscular (IM) injection of 600 mg of BRII-296 achieved dose linearity, early drug absorption, gradual and extended release profiles without the need for dose titration or tapering, providing confidence that this dose has potential to achieve clinical efficacy in the treatment of PPD. The selected dose regimen will be evaluated in a Phase 2 clinical trial that is expected to begin this year. BRII-296 acts as a novel gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) with a unique long-acting formulation that does not require cessation of breastfeeding and enables the drug to be effective for weeks after the patient leaves the injection appointment. It is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD and may offer substantial clinically meaningful advantages over currently available treatment options for PPD. "We are encouraged by the possibility of providing a novel treatment option to the 900,000 people in the U.S. affected by postpartum depression each year in which the current standard of care is suboptimal, often requiring hospitalization, repeat therapy and daily doses of treatment," said Ji Ma, Ph.D., Vice President of Preclinical Development and Clinical Pharmacology at Brii Bio, and lead author. "These data reinforce the potential for BRII-296 to redefine the PPD treatment landscape by providing a one-time, outpatient therapy that may effectively treat a range of depressive symptoms while maintaining a favorable safety and tolerability profile, including minimal exposure to breastfed infants." "Initial results from this study are an important step forward as we continue to advance the development of BRII-296 in a robust and thoughtfully designed Phase 2 clinical study later this year that will incorporate fundamental patient experiences and preferences," said Aleksandar Skuban, M.D., CNS Diseases Therapy Area Head of Brii Bio. "This comprehensive approach to development is critical in areas such as PPD where there are often considerable barriers to accessing care, in part because of wide-reaching social stigmas and a lack of disease awareness. This program reinforces Brii's dedication to operating at the intersection of scientific innovation and patient insights in order to inform the full spectrum of strategic development in mental health conditions such as PPD as well as our broader global public health-inspired pipeline." Data from healthy subjects in cohorts 1-15 were presented in a poster, titled Safety, Tolerability, and Pharmacokinetics of BRII-296, An Extended-Release Injectable Aqueous Suspension Formulation of Brexanolone in Healthy Adult Subjects, at the International Marcé Society Conference taking place in London, United Kingdom September 19-23, 2022. The full Phase 1 dataset will be presented at a scientific meeting later this year. About BRII-296 Phase 1 Trial The completed open-label, Phase 1, single ascending dose study assessed the safety, tolerability and PK of BRII-296 as a single-injection treatment option for PPD in 116 subjects enrolled across 16 cohorts. Three formulation concentrations (100 mg/mL, 200 mg/mL and 300 mg/mL) were administered via one or more IM injections to healthy adults at total dose levels of 30 mg, 75 mg, 100 mg, 200 mg, 300 mg and 600 mg. In addition, oral prophylactic treatment, or local steroid administration with BRII-296 (Depo Medrol via co-injection or admix) were evaluated to manage local injection site reactions (ISRs). The local steroid administration was shown in the study to effectively manage injection site reactions (ISRs). Of the 116 subjects, 98 subjects reported treatment emergent adverse events (TEAEs), with the majority considered drug-related and attributed to ISRs. Most ISRs were mild to moderate in severity and none lead to premature discontinuation from the study. There were no life threatening TEAEs, TEAEs leading to premature discontinuation of study, SAEs, or deaths. About Postpartum Depression Postpartum depression (PPD) is the most common psychological condition impacting people after giving birth. Affecting approximately 900,000 birthing people in the U.S. each year, including those who have miscarried or have had a stillbirth, PPD can present significant physical and mental health risks to the mother. In fact, suicide and overdose are the leading causes of death for childbearing people in the first year following pregnancy. Some healthcare providers believe the prevalence of PPD could be at least double, given unreported and untreated cases. PPD can also have negative effects on the maternal-infant relationship and it may lead to longer-term child development problems. Despite the prevalence and societal impact of PPD, currently approved treatment options remain limited and are associated with significant disruptions to daily life, including required hospitalization, repeat therapy and daily doses of treatment. About BRII-296 BRII-296 is a novel, single injection therapeutic candidate in development for the treatment and prevention of postpartum depression (PPD). It acts as a gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) and is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD with the potential to lead to greater adherence, convenience and fewer side effects compared to the current standard of care. BRII-296 will continue to be evaluated in an upcoming Phase 2 study for the treatment of PPD and is also in development for the prevention PPD. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, and other illnesses, such as the central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit www.briibio.com. SOURCE Brii Biosciences Limited

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。药监部门一直致力于构建科学权威公开的审评标准体系，根据盘点，2022年7月药监局及药审中心共计发布16条医药领域相关通告、其中14条为征求意见稿，2条正式文件稿。药监局公告内容包括疫苗生产流通管理规定、中药材包装管理规定等；药审中心公告则包含临床研发指导技术、安全性评价、生物等效性试验、非临床研究以及药学研发/注册相关指导原则等。如有遗漏，欢迎补充！7月8日，国家药监局发布《疫苗生产流通管理规定》，自发布之日起施行。《疫苗生产流通管理规定》内容共44条，要求生产企业根据疫苗产品特性和疫苗监管要求，依法对疫苗的生产、流通管理活动进行规范。同日，药监局发布《中药饮片包装标签管理规定（征求意见稿）》、《中药饮片保质期研究确定技术指导原则（征求意见稿）》，旨在进一步完善中药饮片的标签管理，引导中药饮片生产企业规范包装标识。7月22日，药监局发布第五十六批仿制药参比制剂目录，包括溃疡性结肠炎治疗药物美沙拉嗪缓释胶囊、慢性肾衰竭并发症治疗药物左卡尼汀注射液等在内的76品规药品被纳入仿制药参比制剂目录名单。7月，药审中心共计发布了12条医药领域相关文件，均为征求意见稿，涉及抗体偶联药物非临床研究、AML新药临床研究、药物真实世界研究等多个领域。7月6日1. 药审中心关于公开征求《组织患者参与药物研发的一般考虑指导原则（征求意见稿）》意见的通知该指导原则旨在为申办者如何组织患者参与到药物研发中来提供参考，将患者信息作为临床试验关键要素之一，纳入整体药物研发计划，提高整体药物研发的质量和成功率，惠及患者、改善临床用药现状，增加临床用药的选择。2. 药审中心关于公开征求《抗体偶联药物非临床研究技术指导原则（征求意见稿）》意见的通知近年来，ADC已在恶性肿瘤等疾病领域显示出巨大的应用潜力，该指导原则从药理学、药代动力学、毒理学以及临床试验和上市的非临床考虑等几个方面为ADC药物非临床研究提供帮助和指导，以获取科学规范的试验数据支持开展后续临床试验和批准上市。7月7日1. 药审中心关于公开征求《药品审评过程中有因检查启动工作程序（征求意见稿）》意见的通知该程序目的是为了加强药品安全监管，规范药品注册审评过程中有因检查启动工作，适用于药审中心正在技术审评中的药品注册申请。2. 药审中心关于公开征求《化学仿制药口服调释制剂乙醇剂量倾泻试验药学研究技术指导原则（征求意见稿）》意见的通知该原则旨在进一步明确化学仿制药口服调释制剂乙醇剂量倾泻试验具体试验方法设计，以更好地指导企业进行研究以及统一监管要求。3. 药审中心关于《药物真实世界研究设计与方案框架指导原则（征求意见稿）》公开征求意见的通知该指导原则重点阐述药物研发中真实世界研究设计以及研究方案制订的基本考虑，为药物研发中开展真实世界研究提供指导意见，也可供以非注册研究为目的的真实世界研究参考。4. 药审中心关于公开征求《注射用两性霉素B脂质体生物等效性研究技术指导原则（征求意见稿）》意见的通知注射用两性霉素B脂质体，为特殊注射剂，生物等效性评价存在一定难度。该指导原则旨在进一步规范注射用两性霉素B脂质体的生物等效性研究。7月13日药审中心关于公开征求《申办者临床试验期间安全性评价和安全性报告技术指导原则（征求意见稿）》意见的通知该指导原则旨在指导申办者建立完善的药物警戒体系，更好地推动和指导申办者对临床试验期间的安全性信息及时评价和报告，明确技术标准和向监管机构报告的要求。7月19日1. 药审中心关于公开征求《药物临床试验期间安全性数据快速报告常见问答（2.0版）》意见的通知该报告旨在进一步促进药物临床试验期间安全性数据快速报告标准统一，提升数据质量。2. 药审中心关于公开征求《急性髓细胞白血病新药临床研发技术指导原则（征求意见稿）》意见的通知急性髓细胞白血病（AML）的治疗策略越来越强调精准化和个体化，给新药临床研发带来了多重挑战。该技术指导原则立足于当前的临床实践，结合AML的疾病特征和近年来新药研发的经验和挑战，就AML新药临床研究的思路和具体设计要素提出观点。7月22日药审中心关于公开征求《基于动物法则的药物注册技术指导原则（征求意见稿）》意见的通知本指导原则旨在为开展人体有效性试验不符合伦理或现场试验不可行的药物的动物有效性试验设计及评价提供一般性技术指导和参考。指导原则就动物模型、充分的和良好对照的动物有效性试验以及外推人体有效剂量等需要重点关注的问题进行阐述。7月25日药审中心关于公开征求《药物临床试验盲法指导原则》意见的通知该指导原则主要阐述对药物临床试验中不同情况下的盲法实施的系统性和规范性要求，旨在为申办者在临床试验中正确设计和实施盲法提供技术性指导，主要适用于以支持药品注册上市为目的的确证性临床试验，也可供以非注册上市为目的的临床试验参考。7月27日药审中心关于公开征求《化学仿制药参比制剂目录（第六十一批）》（征求意见稿）意见的通知本次仿制药参比制剂目录征求意见稿中纳入了抗感染治疗药物醋酸甲泼尼龙注射液、降血压药物盐酸乐卡地平片在内的70品规药品，目前征求意见稿公示时间已截止。7月29日药审中心关于公开征求ICH指导原则《M12：药物相互作用》意见的通知该指导原则旨在促进在治疗药物研发中设计、开展和解释酶或转运体介导的体外和临床药物相互作用（DDI）研究采用一致的方法提供建议。一致的方法将减少制药行业在满足多个监管机构要求时面临的不确定性，并使资源得到更有效的利用。