AbbVie and REGENXBIO Announce Updates on the ABBV-RGX-314 Clinical Program
AbbVie and REGENXBIO Announce Updates on the ABBV-RGX-314 Clinical Program
- Pivotal data evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet age-related macular degeneration (wet AMD) are expected in 2026
- AbbVie and REGENXBIO will plan the Phase 3 clinical program of investigational ABBV-RGX-314 in diabetic retinopathy (DR)
- 評估ABBV-RGX-314在溼性年齡相關性黃斑變性(溼性AMD)患者中進行視網膜下給藥的安全性和有效性的關鍵數據預計將在2026年發佈。
- 艾伯維公司和Regenxbio將計劃在糖尿病視網膜病變(DR)中進行ABBV-RGX-314的第三階段臨牀項目。
NORTH CHICAGO, Ill. and ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced updates to the ABBV-RGX-314 clinical program.
伊利諾伊州北芝加哥和馬里蘭州洛克維爾,2025年1月13日 /PRNewswire/ -- 艾伯維公司(NYSE: ABBV)和Regenxbio公司(納斯達克: RGNX)今天宣佈了ABBV-RGX-314臨牀項目的更新。
ABBV-RGX-314 in Wet Age-Related Macular Degeneration (wet AMD), Subretinal Delivery
Data from the ATMOSPHERE and ASCENT pivotal trials evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet AMD are expected in 2026.
溼性年齡相關性黃斑變性(溼性AMD)中的ABBV-RGX-314,視網膜下給藥
來自ATMOSPHERE和ASCENt關鍵試驗的數據正在評估ABBV-RGX-314在溼性AMD患者中進行視網膜下給藥的安全性和有效性,預計將在2026年發佈。
ABBV-RGX-314 in Diabetic Retinopathy (DR), Suprachoroidal Delivery
AbbVie and REGENXBIO will plan a Phase 3 clinical program. The clinical program will utilize the in-office SCS Microinjector to deliver gene therapy to the suprachoroidal space of the eye.
ABBV-RGX-314在糖尿病視網膜病變(DR)中的超脈絡膜給藥
艾伯維公司和Regenxbio將計劃一個第三階段的臨牀項目。該臨牀項目將使用辦公室內的SCS微注射器將基因治療輸送到眼睛的超脈絡膜空間。
"Retinal diseases are progressive, with wet AMD and DR among the leading causes of blindness," said Michael Robinson, M.D., vice president, global head of ophthalmology clinical development, AbbVie. "More treatment options are needed to help relieve the current treatment burden of chronic, frequent dosing. We are excited to continue moving closer to our goal of delivering an additional treatment option to patients with wet AMD and DR in hopes of addressing their significant unmet needs."
「視網膜疾病是逐漸惡化的,溼性AMD和DR是失明的主要原因,」艾伯維公司全球眼科臨牀發展副總裁Michael Robinson萬博士表示。「需要更多的治療選擇,以幫助緩解當前的慢性、頻繁給藥的治療負擔。我們很高興能繼續朝着爲溼性AMD和DR患者提供額外治療選擇的目標邁進,希望能夠滿足他們明顯的未滿足需求。」
"ABBV-RGX-314 has the potential to help millions of people living with wet AMD and DR, globally, who are facing these debilitating diseases," said Curran Simpson, president and chief executive officer, REGENXBIO. "Together with AbbVie, we are excited to continue developing ABBV-RGX-314 as the first potential one-time gene therapy for wet AMD and DR."
"艾伯維-RGX-314有潛力幫助全球數百萬患有溼性黃斑變性和糖尿病視網膜病變的人,這些疾病使他們備受折磨,"Regenxbio的總裁兼首席執行官Curran Simpson表示。"我們與艾伯維合作,興奮地繼續開發艾伯維-RGX-314,作爲治療溼性黃斑變性和糖尿病視網膜病變的首個潛在一次性基因療法。"
About ABBV-RGX-314
關於艾伯維-RGX-314
ABBV-RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy and potentially other chronic retinal conditions. ABBV-RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). ABBV-RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.1
艾伯維-RGX-314正在作爲一種潛在的一次性治療方法進行研究,針對溼性黃斑變性、糖尿病視網膜病變及其他慢性視網膜病。艾伯維-RGX-314由NAV AAV8載體組成,該載體編碼一種抗體片段,旨在抑制血管內皮生長因數(VEGF)。相信艾伯維-RGX-314通過抑制VEGF途徑來阻止新的漏性血管的生長,從而導致視網膜中的液體積聚。1
AbbVie and REGENXBIO are advancing the development of two separate routes of administration of ABBV-RGX-314 to the eye, through a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. REGENXBIO has licensed certain exclusive rights to the SCS Microinjector from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye.
艾伯維和Regenxbio正在推進兩種不同的艾伯維-RGX-314眼部給藥方式的發展,通過標準化的視網膜下給藥程序以及向脈絡膜上腔的給藥。Regenxbio已從Clearside Biomedical公司獲得某些獨佔權利,以使用SCS微注射器將基因療法治療傳遞到眼睛的脈絡膜上腔。
About Wet AMD
關於溼性黃斑變性
Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina.2 Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to two million people living with wet AMD in these geographies alone.3 Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients.4 These therapies, however, require life-long repeated intraocular injections, to maintain efficacy.5,6 Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time.7
溼性黃斑變性是由於視網膜中新形成的漏性血管而導致視力喪失的疾病。2溼性黃斑變性是美國、歐洲和日本視力喪失的重要原因,僅在這些地區就有多達200萬人生活在溼性黃斑變性中。3當前的抗VEGF療法已經顯著改變了溼性黃斑變性的治療格局,因其能夠防止大多數患者的視力喪失進展而成爲標準療法。4然而,這些療法需要終身重複的眼內注射,以維持療效。5,6由於治療負擔,患者往往會隨着治療頻率降低而經歷視力下降。7
About Diabetic Retinopathy
關於糖尿病視網膜病變
Diabetic retinopathy (DR) is the leading cause of vision loss in adults between 24 and 75 years of age worldwide.8 DR affects nearly 10 million people in the United States alone.9 The spectrum of DR severity ranges from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR).4 As DR progresses, a large proportion of patients develop vision threatening complications, including diabetic macular edema (DME) and neovascularization that can lead to blindness.10 Current treatment options for patients with NPDR typically include "watchful waiting" or anti-VEGF treatment. For patients with PDR, current treatment options include anti-VEGF treatment or retinal laser; surgical treatment may be required for advanced PDR.2
糖尿病視網膜病變(DR)是全球24到75歲成人視力喪失的主要原因。8僅在美國,糖尿病視網膜病變影響近1000萬人。9糖尿病視網膜病變的嚴重程度從非增殖性糖尿病視網膜病變(NPDR)到增殖性糖尿病視網膜病變(PDR)不等。4隨着DR的進展,大部分患者會出現威脅視力的併發症,包括糖尿病黃斑水腫(DME)和新生血管化,可能導致失明。10目前,針對NPDR患者的治療選項通常包括觀察等待或抗VEGF治療。針對PDR患者,當前的治療選項包括抗VEGF治療或視網膜激光治療;對於晚期PDR,可能需要手術治療。2
About AbbVie
關於艾伯維公司
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. AbbVie strives to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in AbbVie's Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
艾伯維公司的使命是發現和提供創新藥物和解決方案,以解決目前嚴重的健康問題,並應對明天的醫療挑戰。艾伯維力求在多個主要治療領域中對人們的生活產生顯著影響——免疫學、腫瘤學、神經科學和眼科——以及艾伯維公司的Allergan Aesthetics產品組合中的產品和服務。有關艾伯維公司的更多信息,請訪問我們的網站 。關注@abbvie在 LinkedIn上。 臉書, Instagram, X(前身爲Twitter),以及 優兔。
ABOUT REGENXBIO Inc.
關於Regenxbio公司
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the development of AAV Therapeutics, an innovative class of gene therapy medicines. REGENXBIO is advancing a pipeline of AAV Therapeutics for rare and retinal diseases, including RGX-202 for the treatment of Duchenne, ABBV-RGX-314 for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, and RGX 121 for the treatment of MPS II. Thousands of patients have been treated with REGENXBIO's AAV Therapeutic platform, including Novartis' ZOLGENSMA for children with spinal muscular atrophy. Designed to be one-time treatments, AAV Therapeutics have the potential to change the way healthcare is delivered for millions of people. For more information, please visit .
Regenxbio是一家領先的臨牀階段生物技術公司,致力於通過基因治療的治癒潛力改善人們的生活。自2009年成立以來,Regenxbio在AAV治療藥物的開發方面開創了先河,這是一種創新的基因治療藥物類別。Regenxbio正在推進針對稀有和視網膜疾病的AAV治療藥物管線,包括用於杜氏肌營養不良症治療的RGX-202,與艾伯維公司合作開發的用於溼性年齡相關性黃斑變性和糖尿病視網膜病變治療的ABBV-RGX-314,以及用於MPS II治療的RGX 121。數千名患者已經接受了Regenxbio的AAV治療平台的治療,包括諾華的ZOLGENSMA,專爲患有脊髓性肌萎縮症的兒童設計。AAV治療藥物旨在一次性治療,有潛力改變數百萬人的醫療服務方式。欲了解更多信息,請訪問。
Forward-Looking Statements
前瞻性聲明
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
本新聞稿中的一些聲明是,或可能被視爲,1995年《私人證券訴訟改革法案》目的下的前瞻性聲明。"相信"、"期望"、"預期"、"預測"以及類似表述和未來或條件動詞的使用,通常標識前瞻性聲明。艾伯維公司警告說,這些前瞻性聲明受到風險和不確定性的影響,這可能導致實際結果與前瞻性聲明所表達或暗示的結果大相徑庭。這些風險和不確定性包括但不限於知識產權的挑戰、來自其他產品的競爭、研發過程中的固有困難、不利的訴訟或政府行動,以及適用於我們行業的法律法規變化。關於可能影響艾伯維公司運營的經濟、競爭、政府、科技及其他因素的更多信息已在艾伯維2023年度報告的第1A項《風險因素》中列出,該報告已向證券交易委員會提交,並由後續的季度報告更新。艾伯維不承擔任何義務,且特別拒絕根據後續事件或發展公開發佈對前瞻性聲明的任何修訂,但法律要求的除外。
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3 Decision Resources Group, 2019
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6 Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.
7 Holz FG et al. Br J Ophthalmol. 2015;99:220.
8 Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010;376(9735):124–36.
9 Lundeen EA, Burke-Conte Z, Rein DB, Wittenborn JS, Saaddine J, Lee AY, Flaxman AD. Prevalence of Diabetic Retinopathy in the US in 2021. JAMA Ophthalmology. 2023;141(8):747-754.
10 Berrocal MD, Alexandra Acabá. Current Management of Diabetic Retinopathy, 2018
1 Penn JS, Madan A, Caldwell Rb, 等。血管內皮生長因數在眼科疾病中的作用。眼科研究進展。2008;27(4):331-71。
2 Carmeliet P. 生命、疾病與醫學中的血管生成。自然。2005;438:932-6。
3 決策資源集團,2019
4 Alexandru MR, Alexandra Nm. 乾性年齡相關性黃斑變性管理與隨訪。羅馬尼亞眼科學雜誌。2016;60:9–13。
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6 Dugel PU, Koh A, Ogura Y, 等。HAWk 和 HARRIER:brolucizumab 治療新生血管型年齡相關性黃斑變性的 3 期、多中心、隨機、雙盲試驗。眼科學。2020;127(1):72-84。
7 Holz FG 等. 英國眼科雜誌. 2015;99:220.
8 Cheung N, Mitchell P, Wong TY. 糖尿病視網膜病變. 柳葉刀. 2010;376(9735):124–36.
9 Lundeen EA, Burke-Conte Z, Rein Db, Wittenborn JS, Saaddine J, Lee AY, Flaxman AD. 2021年美國糖尿病視網膜病變流行率. JAMA眼科. 2023;141(8):747-754.
10 Berrocal MD, Alexandra Acabá. 糖尿病視網膜病變的當前管理, 2018
SOURCE AbbVie
消息來源 艾伯維
譯文內容由第三人軟體翻譯。
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