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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宣佈評估精神分裂症患者Brilaroxazine的開放標籤延期研究的註冊更新
Reviva Pharmaceuticals ·  05/15 12:00

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

— 358名入組,223名患者目前在美國、歐洲和亞洲各地接受治療 —

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

— 迄今爲止,急性和穩定型精神分裂症患者對Brilaroxazine的耐受性總體良好 —

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

— 爲期1年的開放標籤延期(OLE)試驗的關鍵數據預計將於2024年第四季度發佈—

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.

加利福尼亞州庫比蒂諾,2024年5月15日——Reviva Pharmicals Holdings, Inc.(納斯達克股票代碼:RVPH)(“Reviva” 或 “公司”)是一家開發旨在解決中樞神經系統(CNS)、炎症和心臟代謝疾病領域未得到滿足的醫療需求的療法的後期製藥公司,今天宣佈了正在進行的評估長期安全性的爲期1年的開放標籤延期(OLE)研究的最新入學情況以及精神分裂症患者對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."

“我們對OLE研究的入學速度感到非常滿意,該研究在美國、歐洲和亞洲的研究中心進展順利。截至5月中旬,我們有358名患者參加了該研究,223名患者目前正在接受治療,90多名患者已經完成了6-9個月的治療,23名患者已經完成了爲期一年的治療。” Reviva創始人、總裁兼首席執行官Laxminarayan Bhat博士說。“重要的是,我們即將收集100名接受一年治療的患者的長期安全數據,這是我們計劃於2025年第四季度向美國食品藥品監督管理局(FDA)提交新藥申請(NDA)的必要條件。迄今爲止,在OLE研究中,急性和穩定性精神分裂症患者對brilaroxazine的耐受性普遍良好。我們期待在今年第四季度公佈12個月的長期安全數據。”

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

截至 2024 年 5 月 15 日的 RECOVER 試用版 OLE 註冊狀態更新

  • 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
  • 美國、歐洲(保加利亞)和亞洲(印度)的試驗進展如預期
  • 358 名患者參與了該研究
  • 該研究目前有223名患者正在接受治療
  • 目前在研究中的130多名患者已經完成了1-6個月的治療
  • 目前在研究中的90多名患者已經完成了6-9個月的治療
  • 23 名患者已經完成了 12 個月的治療
  • brilaroxazine向美國食品藥品管理局提交保密協議要求提供來自100名已完成12個月治療的患者的長期安全數據
  • Reviva 有望在 2024 年第四季度完成爲期 12 個月的長期安全研究

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.

這個 恢復試用版 OLE 是一項隨機、雙盲、安慰劑對照、多中心研究,旨在評估brilaroxazine對精神分裂症急性發作受試者每天給藥一次,持續28天的療效和安全性,然後對精神分裂症穩定的受試者進行靈活劑量15、30或50 mg的brilaroxazine的長期安全性評估分裂症。OLE研究將包括雙盲翻轉和從頭開始患有穩定精神分裂症的受試者。

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).

關於 brilarozazine
Brilaroxazine是一種內部發現的新化學實體,對與精神分裂症及其合併症狀相關的關鍵血清素和多巴胺受體具有很強的親和力和選擇性。針對精神分裂症的全球 3 期 RECOVER-1 試驗的積極數據表明,該試驗在第 4 周成功滿足了所有主要和次要終點,使用 50 mg brilaroxazine 與安慰劑相比,該試驗在所有主要症狀領域均有統計學意義和臨床意義的降低,副作用總體耐受性與安慰劑相當,停藥率低於安慰劑。一項臨床藥物相互作用 (DDI) 研究的陽性數據表明,當與 CYP3A4 抑制劑聯合使用時,沒有臨床上顯著的相互作用,該研究調查了 CYP3A4 酶對健康受試者中布雷拉唑嗪的潛在影響。Reviva認爲,對brilaroxazine的一系列符合監管要求的毒理學和安全藥理學研究已經完成。Reviva打算開發用於其他神經精神適應症的brilaroxazine,包括躁鬱症、重度抑鬱症(MDD)和注意力缺陷/多動障礙(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在炎症性疾病牛皮癬、肺動脈高壓(PAH)和特發性肺纖維化(IPF)方面顯示出令人鼓舞的非臨床活性,在轉化動物模型中可以緩解纖維化和炎症。Brilaroxazine已獲得美國食品藥品管理局的孤兒藥認定,用於治療PAH和IPF疾病。要了解有關brilaroxazine的臨床和臨床前數據的更多信息,請訪問 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.

關於 Reviva
Reviva是一家處於後期階段的生物製藥公司,致力於爲社會、患者及其家庭帶來未得到滿足的醫療需求和負擔的疾病發現、開發和尋求將下一代療法商業化。Reviva目前的產品線側重於中樞神經系統(CNS)、炎症和心臟代謝疾病。Reviva的產品線目前包括兩種候選藥物,即brilaroxazine(RP5063)和 RP1208。兩者都是內部發現的新化學實體。Reviva 已在美國、歐洲和其他幾個國家獲得了 brilaroxazine 和 RP1208 的物質組合專利。

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.

前瞻性陳述
本新聞稿包含1933年《證券法》第27A條和經修訂的《1934年證券交易法》第21E條和經修訂的《私人證券訴訟改革法》所指的某些前瞻性陳述,包括與公司評估精神分裂症患者brilaroxazine長期安全性和耐受性的1年開放標籤延期(OLE)試驗、註冊性第三階段 RECOVER-2 試驗、公司對其候選產品的預期臨床概況,包括有關預期療效或安全概況的聲明,以及與公司在產品開發、臨床和監管時間表和開支、計劃或額外研究、計劃或計劃提交的監管文件、市場機會、籌集足夠資金的能力、競爭地位、可能或假設的未來經營業績、業務戰略、包括合作伙伴關係、增長或擴張機會在內的潛在發展機會等方面的預期、意圖或信念相關的聲明本質上是預測性的陳述。這些前瞻性陳述基於當前對我們經營的行業和市場的預期、估計、預測和預測以及管理層當前的信念和假設。

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.

這些陳述可以通過使用前瞻性表達來識別,包括但不限於 “期望”、“預期”、“打算”、“計劃”、“相信”、“估計”、“潛力”、“預測”、“項目”、“應該”、“將” 和類似的表述以及這些術語的否定詞。這些陳述與未來事件或我們的財務業績有關,涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致實際業績、業績或成就與前瞻性陳述所表達或暗示的任何未來業績、業績或成就存在重大差異。這些因素包括公司最新的10-K表年度報告中列出的因素,以及公司不時向美國證券交易委員會提交的其他文件。提醒潛在投資者不要過分依賴此類前瞻性陳述,這些陳述僅代表截至本新聞稿發佈之日。公司沒有義務公開更新任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。

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

公司聯繫人:
Reviva 製藥控股有限公司
Laxminarayan Bhat,博士
www.revivapharma.com

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

投資者關係聯繫人:
LifeSci 顧問有限公司
布魯斯·麥克爾
bmackle@lifesciadvisors.com

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

媒體聯繫人:
克里斯汀·波利蒂
kpoliti@lifescicomms.com
(646) 876-4783

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