临床试验
除了资助PFS研究外,PFS基金会还密切关注经FDA批准的药品试验,这些有望面市 的药品尚处于临床开发阶段。
Sage Therapeutics四氢孕酮及其同类产品,目前正在分别进行包括重度抑郁症和失眠症在内的各种适应症的试验。2018年6月,Sage在与美国FDA进行突破性疗法会议后宣布,将加速其新药SAGE-217的研发计划。 该计划旨在支持SAGE-217用于治疗重度抑郁症(MDD)和产后抑郁症(PPD)在美国的获批。Sage首席执行官杰夫乔纳斯表示“如果SAGE-217研发成功并获得批准,可能会改写如何治疗数千MDD患者的教科书,最终将抑郁症变成一种疾病,而不是一种身份,”
- (Nov. 14, 2023) PureTech’s LYT-300 (Oral Allopregnanolone) Achieved Primary Endpoint in a Phase 2a Acute Anxiety Trial in Healthy Volunteers
- (Aug. 4, 2023) FDA Approves First Oral Treatment for Postpartum Depression
- (May 2, 2022) Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application to US Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder
- (Dec. 5, 2019) Sage Therapeutics Reports Topline Results from Pivotal Phase 3 MOUNTAIN Study of SAGE-217 in Major Depressive Disorder
- (Sept. 5, 2019) The New England Journal of Medicine: Trial of SAGE-217 in Patients with Major Depressive Disorder
- (April 11, 2019) Neurologic disease research at UC Davis contributes to first treatment specifically approved for postpartum depression
- (March 19, 2019) Sage Therapeutics Announces FDA Approval of ZULRESSO (brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression
- (Feb. 19, 2019) Sage Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Highlights Pipeline and Business Progress
- (Jan. 7, 2019) Sage Therapeutics Announces SAGE-217 Meets Primary and Secondary Endpoints in Phase 3 Clinical Trial in Postpartum Depression
- (Nov. 2, 2018) Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of ZULRESSO (brexanolone) Injection for Treatment of Postpartum Depression
- (June 12, 2018) Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA Breakthrough Therapy Meeting
- (Jan. 31, 2018) Sage Therapeutics Announces Positive Results from Placebo-Controlled Trial in a Model of Insomnia Demonstrating Activity on Sleep Parameters and Supporting Development of SAGE-217 as Potential Treatment for Sleep Disorders
- (Dec. 7, 2017) Sage Therapeutics Reports Positive Top-line Results from Phase 2 Placebo-Controlled Trial of SAGE-217 in Major Depressive Disorder
研究目标
确定PFS的潜在生物学机制,进而为该病患者研究有效的疗法,需要持续的临床,基础科学和统计研究。 目前的研究重点是在分子水平上确定PFS 的潜在生物学机制,未来也是如此。 具体来说:
- PFS的遗传风险因素
- PFS患者的雄激素受体表达
- PFS患者的激素水平
- PFS患者的全基因组基因表达谱和通路分析
- 雄激素应答基因编码的蛋白质(ARGs)
- PFS患者的神经甾体水平
- PFS患者的表观遗传染色质改变