Outlook Therapeutics Announces Completion of Enrollment in NORSE EIGHT Clinical Trial
Outlook Therapeutics Announces Completion of Enrollment in NORSE EIGHT Clinical Trial
As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT) to support the resubmission of the ONS-5010 BLA. In January 2024, Outlook Therapeutics received written agreement on the NORSE EIGHT trial protocol and statistical analysis plan from the FDA under the SPA. The SPA also confirms in writing that if the NORSE EIGHT trial is successful, it would satisfy the FDA's requirement for a second adequate and well-controlled clinical trial to fully address the clinical deficiency identified in the CRL. In addition, Outlook Therapeutics has completed Type C and Type D meetings with the FDA to address the open chemical, manufacturing and control (CMC) items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.- Topline results from NORSE EIGHT expected in Q4 CY2024
- NORSE EIGHt的最新業績預計在2024年第四季度公佈
ISELIN, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. NORSE EIGHT is the subject of a Special Protocol Assessment (SPA) agreement with the FDA, and, if successful, is the final anticipated clinical trial required before expected resubmission of the Outlook Therapeutics' Biologics License Application (BLA) for ONS-5010.
紐澤西州ISELIN，2024年9月4日(GLOBE NEWSWIRE)-- Outlook Therapeutics，Inc. (納斯達克：OTLK)是一家生物製品公司，此前在今年早些時候獲得了在歐洲聯盟和英國的第一批使用眼科製劑別嘌醇酸的治療濕性年齡相關性黃斑變性(wet AMD)的監管批准，今天宣佈其NORSE EIGHt臨床試驗已完成患有濕性年齡相關性黃斑變性的患者的招募。NORSE EIGHt是與FDA簽署的特殊議定書(SPA)協議的主題，如果成功，它將是期望重新提交Outlook Therapeutics的生物製品許可申請(BLA)ONS-5010之前所必需的最後一項臨床試驗。
NORSE EIGHT is a randomized, controlled, parallel-group, masked, non-inferiority study of newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint is mean change in best corrected visual acuity (BCVA) from baseline to week 8. Outlook Therapeutics remains on track to report NORSE EIGHT topline results in Q4 CY2024. The resubmission of the ONS-5010 BLA is planned for Q1 CY2025.
NORSE EIGHt是一項隨機、對照、平行組、掩蓋、非劣效性研究，對新診斷的濕性年齡相關性黃斑變性受試者以1:1的比例隨機接受1.25毫克ONS-5010或0.5毫克ranibizumab玻璃體注射。受試者將在第0天(隨機化)、第4周和第8周的訪問時接受注射。主要終點是基線到第8周最佳矯正視力(acuity)的平均變化。Outlook Therapeutics仍然計劃在2024年第四季度報告NORSE EIGHt的最新業績。ONS-5010 BLA的重新提交計劃於2025年第一季度。
"We are very pleased to complete this important milestone in our effort to resubmit our BLA for ONS-5010. On behalf of Outlook Therapeutics, I would like to express gratitude to the patients and dedicated teams at the clinical sites, as well as our clinical and regulatory staff, who enrolled this entire patient population in less than 8 months after our SPA agreement from FDA," commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. "We remain confident in the potential of ONS-5010, if approved, to meet the needs of retina specialists, patients, and payers. With enrollment now complete, we plan to report topline efficacy results in the fourth calendar quarter of this year."
"我們非常高興完成了重新提交ONS-5010生物製品許可申請的重要里程碑。我代表Outlook Therapeutics，要感謝在SPA協議簽署不到8個月後，將整個患者人口招募完畢的臨床站的患者和敬業的團隊，以及我們的臨床和監管人員。"Outlook Therapeutics的總裁兼首席執行官Russell Trenary說。"我們對ONS-5010的潛力依然充滿信心，如果獲得批准，它將滿足視網膜專家、患者和支付者的需求。隨着招募工作的完成，我們計劃在今年第四個日曆季度報告其效力的最新數據。"
As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT) to support the resubmission of the ONS-5010 BLA. In January 2024, Outlook Therapeutics received written agreement on the NORSE EIGHT trial protocol and statistical analysis plan from the FDA under the SPA. The SPA also confirms in writing that if the NORSE EIGHT trial is successful, it would satisfy the FDA's requirement for a second adequate and well-controlled clinical trial to fully address the clinical deficiency identified in the CRL. In addition, Outlook Therapeutics has completed Type C and Type D meetings with the FDA to address the open chemical, manufacturing and control (CMC) items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.
根據之前公告，滿世界治療公司與FDA在2023年第四季度進行了A類會議，以應對 ONS-5010 的完全回覆信。FDA通知Outlook Therapeutics，可以進行一項非劣效性研究，評估 ONS-5010 相對於拉尼珠單抗在12周的治療新手病人，以8周的主要療效終點(NORSE EIGHT)來支持 ONS-5010 的重新提交BLA。2024年1月，Outlook Therapeutics收到了FDA關於 NORSE EIGHT 試驗方案和統計分析方案的書面同意。該書面同意還確認，如果 NORSE EIGHT 試驗取得成功，將滿足FDA對於第二個足夠和很好控制的臨床試驗的要求，以完全解決 CRL 中所指出的臨床不足。此外，Outlook Therapeutics已經完成了與FDA的C類和D類會議，以解決CRL中關於化學品、製造和控制(CMC)的問題，並希望在 NORSE EIGHT 試驗預期完成之前解決這些問題。
If approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA (bevacizumab-vikg) directly in the U.S. and is also assessing partnering options for LYTENAVA (bevacizumab gamma) in Europe and other regions outside of the U.S.
如果獲得FDA批准，Outlook Therapeutics計劃在美國直接商業化 ONS-5010/LYTENAVA (貝伐單抗-維卡毫克)，同時還在歐洲和美國以外地區評估 LYTENAVA (貝伐單抗伽瑪) 的合作伙伴選項。
For more information about the NORSE EIGHT study, visit clinicaltrials.gov and reference identifier NCT06190093.
有關NORSE EIGHT研究的更多信息，請訪問 clinicaltrials.gov 並參考標識符 NCT06190093。
About ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab gamma)
關於ONS-5010/LYTENAVA(bevacizumab gamma)
ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the European Union (EU) and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet age-related macular degeneration (wet AMD).
ONS-5010/LYTENAVA是一種治療溼性AMD的眼科用貝伐單抗配方。 LYTENAVA (貝伐單抗伽瑪) 獲得了歐洲委員會在歐洲聯盟 (EU) 和藥品與醫療保健產品管制機構 (MHRA) 在英國授權的中央化營銷授權，用於治療溼性年齡相關性黃斑變性 (wet AMD)。
In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD.
在美國，ONS-5010/LYTENAVA（別嘌呤單抗伽馬）正在接受評估，用於治療溼性年齡相關性黃斑變性的非劣性研究正在進行中。
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF's biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
Bevacizumab-vikg (歐盟和英國的bevacizumab gamma)是一種重組人源的人工合成的單克隆抗體（mAb），具有高親和力選擇性結合人血管內皮生長因子（VEGF）的所有亞型，並通過空間阻斷VEGF與其表面內皮細胞上的受體Flt-1（VEGFR-1）和KDR（VEGFR-2）的結合，中和VEGF的生物活性。注射視網膜內後，bevacizumab與VEGF的結合防止VEGF與其在內皮細胞表面上的受體的相互作用，減少內皮細胞增殖、血管滲漏和視網膜新血管形成。
About Outlook Therapeutics, Inc.
關於Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Chief Executive Officer
Forward-Looking Statements
前瞻性聲明
This press release contains forward-looking statements. All statements other than statements of historical facts are "forward-looking statements," including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "expect," "may," "plan," "potential," "target," "will," or "would" the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, ONS-5010's potential as the first and only European Commission, MHRA or FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the EU, UK, and United States, the timing for completion of NORSE EIGHT and resubmission of the BLA for ONS-5010, expectations concerning Outlook Therapeutics' ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, including with respect to an additional clinical trial and CMC issues, expectations concerning decisions of regulatory bodies and the timing thereof, plans for commercial launch of ONS-5010 in the UK and EU and the timing thereof, including the potential to launch with a partner, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics' resources, as well as those risks detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2023, filed with the SEC on December 22, 2023, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
OTLK@jtcir.com
投資者諮詢：
Jenene Thomas
首席執行官
JTC Team，LLC
OTLK @ jtcir.com
譯文內容由第三人軟體翻譯。
