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Reviva将在SIRS 2024年会上展示吡唑嗪治疗精神分裂症的RECOVER 3期临床试验数据

Reviva to Present RECOVER Phase 3 Clinical Trial Data for Brilaroxazine in Schizophrenia at the SIRS 2024 Annual Meeting

BioSpace 等信源发布 2024-03-28 17:28

可切换为仅中文


CUPERTINO, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- 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 that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will be presenting at the 2024 Schizophrenia International Research Society (SIRS) Annual Meeting, to be held April 3-7, 2024, in Florence, Italy..

加利福尼亚州库比蒂诺,2024年3月28日(环球通讯社)--Reviva Pharmaceuticals Holdings,Inc.(NASDAQ:RVPH)(“Reviva”或“公司”),一家开发治疗方法的晚期制药公司,旨在解决中枢神经系统(CNS)、炎症和心脏代谢疾病领域未满足的医疗需求,今天宣布Reviva的创始人、总裁兼首席执行官Laxminarayan Bhat博士将出席2024年4月3日至7日在意大利佛罗伦萨举行的2024年精神分裂症国际研究学会(SIRS)年会。。

Details for the Oral and poster presentations can be found below:

口头和海报演示的详细信息可以在下面找到:

Presentation Title: Brilaroxazine Phase 3 Recover Trial in Acute Schizophrenia Supports Efficacy, Safety, and Effects on Neuroinflammation

演讲标题:急性精神分裂症的Brilaroxazine 3期Recover试验支持疗效,安全性和对神经炎症的影响

Oral Presentation Date and Time: Thursday, April 4, 2024 at 10:25 – 10:45 AM CET

口头陈述日期和时间:2024年4月4日星期四上午10:25–10:45 CET

Poster Presentation Date and Time: Thursday, April 4, 2024 at 12:00 – 2:00 PM CET

海报展示日期和时间:2024年4月4日星期四,欧洲中部时间下午12:00–2:00

Poster Number: T291

海报编号:T291

Presenter: Laxminarayan Bhat, Reviva Pharmaceuticals

主持人:Reviva Pharmaceuticals的Laxminarayan Bhat

Location: Florence, Italy

地点:意大利佛罗伦萨

About Brilaroxazine

关于布里拉嗪

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.

Brilaroxazine是一种内部发现的新化学实体,对精神分裂症及其合并症中涉及的关键血清素和多巴胺受体具有强大的亲和力和选择性。来自精神分裂症全球3期RECOVER-1试验的阳性topline数据表明,该试验成功地满足了所有主要和次要终点,在第4周时,所有主要症状领域的统计学显着和临床意义上的减少均为50 mg 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.

安慰剂具有与安慰剂相当的一般耐受性良好的副作用,停药率低于安慰剂。一项临床药物相互作用(DDI)研究的阳性数据调查了CYP3A4酶对健康受试者中brilaroxazine的潜在影响,当与CYP3A4抑制剂联合使用时,不支持临床上显着的相互作用。

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)..

Reviva认为,brilaroxazine已经完成了一系列符合法规的毒理学和安全药理学研究。Reviva计划开发brilaroxazine用于其他神经精神适应症,包括躁郁症,重性抑郁障碍(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.

此外,brilaroxazine对炎症性疾病牛皮癣,肺动脉高压(PAH)和特发性肺纤维化(IPF)显示出有希望的非临床活性,并在转化动物模型中减轻了纤维化和炎症。Brilaroxazine已被美国指定为孤儿药。

FDA for the treatment of PAH and IPF conditions..

FDA用于治疗PAH和IPF疾病。。

To learn more about the clinical and preclinical data available for brilaroxazine, please visit https://revivapharma.com/publications/.

要了解有关brilaroxazine可用的临床和临床前数据的更多信息,请访问https://revivapharma.com/publications/.

About Reviva

关于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 central nervous system (CNS), inflammatory and cardiometabolic diseases.

Reviva是一家晚期生物制药公司,它发现、开发并寻求将下一代治疗药物商业化,以治疗代表未满足的医疗需求和对社会、患者及其家人的负担的疾病。Reviva目前的管道专注于中枢神经系统(CNS),炎症和心脏代谢疾病。

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..

Reviva的管道目前包括两种候选药物,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brilaroxazine和RP1208的物质组成专利。。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含《1933年证券法》第27A节、《1934年证券交易法》第21E节和《私人证券诉讼改革法》修订版含义范围内的某些前瞻性声明,包括与公司评估精神分裂症中brilaroxazine的长期安全性和耐受性的1年开放标签延长(OLE)试验有关的声明,注册3期RECOVER-2试验,公司对其候选产品预期临床特征的期望,包括关于预期疗效或安全性的声明,以及与公司对产品开发、临床和监管时间表和费用、计划或额外研究等事项的期望、意图或信念有关的声明。或预期的监管提交、市场机会、筹集足够资金的能力、竞争地位、可能或假定的未来经营成果、业务战略,潜在的发展机会,包括伙伴关系、增长或扩张机会以及其他具有预测性的陈述。

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..

这些前瞻性陈述基于对我们经营的行业和市场的当前预期、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.

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”、“将会”以及类似的表达和这些术语的否定之处。这些报表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结果、业绩或成就与前瞻性报表明示或暗示的任何未来结果、业绩或成绩存在重大差异。

Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2022, 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.

这些因素包括公司截至2022年12月31日财年的最新10-K表年度报告中规定的因素,以及公司不时向美国证券交易委员会提交的其他文件。警告潜在投资者不要过度依赖此类前瞻性声明,这些声明仅在本新闻稿发布之日起生效。

The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise..

公司没有义务公开更新任何前瞻性声明,无论是由于新信息、未来事件还是其他原因。。

Corporate Contact:

公司联系人:

Reviva Pharmaceuticals Holdings, Inc.

Reviva制药控股有限公司。

Laxminarayan Bhat, PhD

Laxminarayan Bhat博士

www.revivapharma.com

www.revivapharma.com

Investor Relations Contact:

投资者关系联系人:

LifeSci Advisors, LLC

LifeSci Advisors有限责任公司

Bruce Mackle

Bruce Mackle

bmackle@lifesciadvisors.com

bmackle@lifesciadvisors.com

Media Contact:

媒体联系人:

Kristin Politi

克里斯汀警方

kpoliti@lifescicomms.com

kpoliti@lifescicomms.com

(646) 876-4783

(646) 876-4783