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Reviva Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia

Reviva Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia

Reviva宣布评估精神分裂症患者Brilaroxazine的开放标签延期研究的注册更新
Reviva Pharmaceuticals ·  05/15 00:00

– 358 enrolled and 223 patients currently on treatment across sites in the USA, Europe and Asia –

— 358名入组,223名患者目前在美国、欧洲和亚洲各地接受治疗 —

– Brilaroxazine is generally well tolerated to date in patients with acute and stable schizophrenia –

— 迄今为止,急性和稳定型精神分裂症患者对Brilaroxazine的耐受性总体良好 —

– Topline data from 1-year open-label extension (OLE) trial expected in Q4 2024 –

— 为期1年的开放标签延期(OLE)试验的关键数据预计将于2024年第四季度发布—

CUPERTINO, Calif., May 15, 2024 — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) ("Reviva" or the "Company"), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced an enrollment update to the ongoing 1-year open-label extension (OLE) study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia.

加利福尼亚州库比蒂诺,2024年5月15日——Reviva Pharmicals Holdings, Inc.(纳斯达克股票代码:RVPH)(“Reviva” 或 “公司”)是一家开发旨在解决中枢神经系统(CNS)、炎症和心脏代谢疾病领域未得到满足的医疗需求的疗法的后期制药公司,今天宣布了正在进行的评估长期安全性的为期1年的开放标签延期(OLE)研究的最新入学情况以及精神分裂症患者对brilaroxazine的耐受性。

"We are very pleased with the pace of enrollment of our OLE study, which is progressing well across sites in the USA, Europe and Asia. As of mid-May we have 358 patients enrolled in the study, 223 patients that are currently on treatment, over 90 patients have completed 6-9 months, and 23 patients who have completed one year of treatment," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. "Importantly, we are close to gathering long-term safety data in 100 patients with one year of treatment, which is a requirement for our planned New Drug Application (NDA) submission to the Food and Drug Administration (FDA) expected in Q4 2025. To date, brilaroxazine has been generally well tolerated across patients with acute and stable schizophrenia in the OLE study. We look forward to reporting topline 12 months long-term safety data in the fourth quarter of this year."

“我们对OLE研究的入学速度感到非常满意,该研究在美国、欧洲和亚洲的研究中心进展顺利。截至5月中旬,我们有358名患者参加了该研究,223名患者目前正在接受治疗,90多名患者已经完成了6-9个月的治疗,23名患者已经完成了为期一年的治疗。” Reviva创始人、总裁兼首席执行官Laxminarayan Bhat博士说。“重要的是,我们即将收集100名接受一年治疗的患者的长期安全数据,这是我们计划于2025年第四季度向美国食品药品监督管理局(FDA)提交新药申请(NDA)的必要条件。迄今为止,在OLE研究中,急性和稳定性精神分裂症患者对brilaroxazine的耐受性普遍良好。我们期待在今年第四季度公布12个月的长期安全数据。”

RECOVER Trial OLE Enrollment Status Update As of May 15, 2024

截至 2024 年 5 月 15 日的 RECOVER 试用版 OLE 注册状态更新

  • Trial progressing as expected in the USA, Europe (Bulgaria) and Asia (India)
  • 358 patients enrolled in the study
  • 223 patients currently on treatment in the study
  • Over 130 patients currently in the study have completed 1-6 months of treatment
  • Over 90 patients currently in the study have completed 6-9 months of treatment
  • 23 patients have completed 12 months of treatment
  • Long-term safety data from 100 patients who have completed 12 months of treatment is a requirement for brilaroxazine's NDA submission to the FDA
  • Reviva is on track to complete the 12 months long-term safety study in Q4 2024
  • 美国、欧洲(保加利亚)和亚洲(印度)的试验进展如预期
  • 358 名患者参与了该研究
  • 该研究目前有223名患者正在接受治疗
  • 目前在研究中的130多名患者已经完成了1-6个月的治疗
  • 目前在研究中的90多名患者已经完成了6-9个月的治疗
  • 23 名患者已经完成了 12 个月的治疗
  • brilaroxazine向美国食品药品管理局提交保密协议要求提供来自100名已完成12个月治疗的患者的长期安全数据
  • Reviva 有望在 2024 年第四季度完成为期 12 个月的长期安全研究

The RECOVER Trial OLE is a randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of brilaroxazine at fixed doses of 15 mg or 50 mg, administered once daily for 28 days in subjects with an acute exacerbation of schizophrenia, followed by the long-term safety assessment of brilaroxazine at flexible doses of either 15, 30 or 50 mg administered once daily for 52 weeks in subjects with stable schizophrenia. The OLE study will include both double-blind rollover and de novo subjects with stable schizophrenia.

这个 恢复试用版 OLE 是一项随机、双盲、安慰剂对照、多中心研究,旨在评估brilaroxazine对精神分裂症急性发作受试者每天给药一次,持续28天的疗效和安全性,然后对精神分裂症稳定的受试者进行灵活剂量15、30或50 mg的brilaroxazine的长期安全性评估分裂症。OLE研究将包括双盲翻转和从头开始患有稳定精神分裂症的受试者。

About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER-1 trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).

关于 brilarozazine
Brilaroxazine是一种内部发现的新化学实体,对与精神分裂症及其合并症状相关的关键血清素和多巴胺受体具有很强的亲和力和选择性。针对精神分裂症的全球 3 期 RECOVER-1 试验的积极数据表明,该试验在第 4 周成功满足了所有主要和次要终点,使用 50 mg brilaroxazine 与安慰剂相比,该试验在所有主要症状领域均有统计学意义和临床意义的降低,副作用总体耐受性与安慰剂相当,停药率低于安慰剂。一项临床药物相互作用 (DDI) 研究的阳性数据表明,当与 CYP3A4 抑制剂联合使用时,没有临床上显著的相互作用,该研究调查了 CYP3A4 酶对健康受试者中布雷拉唑嗪的潜在影响。Reviva认为,对brilaroxazine的一系列符合监管要求的毒理学和安全药理学研究已经完成。Reviva打算开发用于其他神经精神适应症的brilaroxazine,包括躁郁症、重度抑郁症(MDD)和注意力缺陷/多动障碍(ADHD)。

Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.

此外,brilaroxazine在炎症性疾病牛皮癣、肺动脉高压(PAH)和特发性肺纤维化(IPF)方面显示出令人鼓舞的非临床活性,在转化动物模型中可以缓解纤维化和炎症。Brilaroxazine已获得美国食品药品管理局的孤儿药认定,用于治疗PAH和IPF疾病。要了解有关brilaroxazine的临床和临床前数据的更多信息,请访问 revivapharma.com/出版物

About Reviva
Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva's current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva's pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.

关于 Reviva
Reviva是一家处于后期阶段的生物制药公司,致力于为社会、患者及其家庭带来未得到满足的医疗需求和负担的疾病发现、开发和寻求将下一代疗法商业化。Reviva目前的产品线侧重于中枢神经系统(CNS)、炎症和心脏代谢疾病。Reviva的产品线目前包括两种候选药物,即brilaroxazine(RP5063)和 RP1208。两者都是内部发现的新化学实体。Reviva 已在美国、欧洲和其他几个国家获得了 brilaroxazine 和 RP1208 的物质组合专利。

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company's 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company's expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company's expectations, intentions or beliefs regarding matters including product development, clinical and regulatory timelines and expenses, planned or additional studies, planned or intended regulatory submissions, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

前瞻性陈述
本新闻稿包含1933年《证券法》第27A条和经修订的《1934年证券交易法》第21E条和经修订的《私人证券诉讼改革法》所指的某些前瞻性陈述,包括与公司评估精神分裂症患者brilaroxazine长期安全性和耐受性的1年开放标签延期(OLE)试验、注册性第三阶段 RECOVER-2 试验、公司对其候选产品的预期临床概况,包括有关预期疗效或安全概况的声明,以及与公司在产品开发、临床和监管时间表和开支、计划或额外研究、计划或计划提交的监管文件、市场机会、筹集足够资金的能力、竞争地位、可能或假设的未来经营业绩、业务战略、包括合作伙伴关系、增长或扩张机会在内的潜在发展机会等方面的预期、意图或信念相关的声明本质上是预测性的陈述。这些前瞻性陈述基于当前对我们经营的行业和市场的预期、估计、预测和预测以及管理层当前的信念和假设。

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's most recent Annual Report on Form 10-K, and the Company's other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

这些陈述可以通过使用前瞻性表达来识别,包括但不限于 “期望”、“预期”、“打算”、“计划”、“相信”、“估计”、“潜力”、“预测”、“项目”、“应该”、“将” 和类似的表述以及这些术语的否定词。这些陈述与未来事件或我们的财务业绩有关,涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致实际业绩、业绩或成就与前瞻性陈述所表达或暗示的任何未来业绩、业绩或成就存在重大差异。这些因素包括公司最新的10-K表年度报告中列出的因素,以及公司不时向美国证券交易委员会提交的其他文件。提醒潜在投资者不要过分依赖此类前瞻性陈述,这些陈述仅代表截至本新闻稿发布之日。公司没有义务公开更新任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。

Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com

公司联系人:
Reviva 制药控股有限公司
Laxminarayan Bhat,博士
www.revivapharma.com

Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle
bmackle@lifesciadvisors.com

投资者关系联系人:
LifeSci 顾问有限公司
布鲁斯·麦克尔
bmackle@lifesciadvisors.com

Media Contact:
Kristin Politi
kpoliti@lifescicomms.com
(646) 876-4783

媒体联系人:
克里斯汀·波利蒂
kpoliti@lifescicomms.com
(646) 876-4783

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