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ATyr Pharma Announces Dosing Of First Patient In Pivotal Phase 3 EFZO-FIT Study Of Efzofitimod In Patients With Pulmonary Sarcoidosis
ATyr Pharma Announces Dosing Of First Patient In Pivotal Phase 3 EFZO-FIT Study Of Efzofitimod In Patients With Pulmonary Sarcoidosis
Multiple centers in the U.S. are open for enrollment for double-blind, randomized, placebo-controlled study.
Primary endpoint will evaluate steroid-sparing effect of efzofitimod compared to placebo.
EFZO-FIT builds on positive results from Phase 1b/2a study which demonstrated dose dependent improvements across steroid reduction, lung function and symptom control endpoints.
SAN DIEGO, Sept. 27, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that it has dosed the first patient in the global pivotal EFZO-FIT study. The Phase 3 study will evaluate the efficacy and safety of the company's lead therapeutic candidate, efzofitimod, compared to placebo in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD).
Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory diseases states via selective modulation of neuropilin-2 (NRP2). The design of the EFZO-FIT study is supported by safety and efficacy data from a Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. Efzofitimod has been granted FDA Orphan Drug and Fast Track designations for sarcoidosis.
"We are delighted to begin patient dosing in EFZO-FIT. With multiple centers in the U.S. open for enrollment, this very important study for patients with pulmonary sarcoidosis is underway," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "This is an important step forward to delivering a transformative, disease modifying therapy that we believe can reduce the burden of steroids and provide clinically meaningful outcomes for patients with this complex disease."
"We are excited to collaborate with aTyr as they advance this study of a promising new treatment that could potentially improve the lives of sarcoidosis patients worldwide," said Mary McGowan, Chief Executive Officer of the Foundation for Sarcoidosis Research.
The EFZO-FIT study is a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll 264 subjects with pulmonary sarcoidosis at multiple centers in North America, Europe and Japan. The trial design will incorporate a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.
More information on the EFZO-FIT study is available at (NCT05415137) and .
Multiple centers in the U.S. are open for enrollment for double-blind, randomized, placebo-controlled study.
美國的多箇中心開放參加雙盲、隨機、安慰劑對照研究。
Primary endpoint will evaluate steroid-sparing effect of efzofitimod compared to placebo.
主要終點將評估efzofitimod與安慰劑相比的類固醇節省效果。
EFZO-FIT builds on positive results from Phase 1b/2a study which demonstrated dose dependent improvements across steroid reduction, lung function and symptom control endpoints.
EFZO-FIT建立在1b/2a期研究的積極結果基礎上,該研究表明,類固醇減少、肺功能和症狀控制終點的改善依賴於劑量。
SAN DIEGO, Sept. 27, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (NASDAQ:LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that it has dosed the first patient in the global pivotal EFZO-FIT study. The Phase 3 study will evaluate the efficacy and safety of the company's lead therapeutic candidate, efzofitimod, compared to placebo in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD).
聖迭戈,9月2022年3月27日(環球網)--生物治療公司泰爾製藥公司(納斯達克市場代碼:LIFE)今天宣佈,它已經為全球關鍵的EFZO-FIT研究中的首位患者開出了藥物劑量。第三階段研究將評估該公司的主要候選治療藥物efzofitimod與安慰劑治療肺結節病患者的療效和安全性。肺結節病是間質性肺部疾病(ILD)的一種主要形式。
Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory diseases states via selective modulation of neuropilin-2 (NRP2). The design of the EFZO-FIT study is supported by safety and efficacy data from a Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. Efzofitimod has been granted FDA Orphan Drug and Fast Track designations for sarcoidosis.
Efzofitimod是一種一流的免疫調節劑,通過選擇性調節神經粘連蛋白-2(NRP2),在無法控制的炎症性疾病狀態下下調固有和獲得性免疫反應。EFZO-FIT試驗的設計得到了EFZO-FIT試驗1b/2a期試驗的安全性和有效性數據的支持,該試驗用於肺結節病患者。Efzofitimod已被FDA授予治療結節病的孤兒藥物和快速通道稱號。
"We are delighted to begin patient dosing in EFZO-FIT. With multiple centers in the U.S. open for enrollment, this very important study for patients with pulmonary sarcoidosis is underway," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "This is an important step forward to delivering a transformative, disease modifying therapy that we believe can reduce the burden of steroids and provide clinically meaningful outcomes for patients with this complex disease."
ATyr首席執行官桑傑·S·舒克拉醫學博士兼首席執行官桑傑·S·舒克拉説:“我們很高興開始給患者服用EFZO-FIT。隨着美國的多箇中心開放招生,這項針對肺結節病患者的非常重要的研究正在進行中。這是朝着提供一種變革性的疾病修正療法邁出的重要一步,我們相信這種療法可以減輕類固醇的負擔,併為這種複雜疾病的患者提供臨牀上有意義的結果。“
"We are excited to collaborate with aTyr as they advance this study of a promising new treatment that could potentially improve the lives of sarcoidosis patients worldwide," said Mary McGowan, Chief Executive Officer of the Foundation for Sarcoidosis Research.
結節病研究基金會首席執行官瑪麗·麥高恩説:“我們很高興能與aTyr公司合作,因為他們正在推進這項有前景的新療法的研究,這種療法可能會改善世界各地結節病患者的生活。
The EFZO-FIT study is a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll 264 subjects with pulmonary sarcoidosis at multiple centers in North America, Europe and Japan. The trial design will incorporate a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.
EFZO-FIT這項研究是一項全球性的3期隨機、雙盲、安慰劑對照研究,旨在評估efzofitimod在肺結節病患者中的療效和安全性。這是一項為期52周的研究,包括三個平行的隊列,隨機分為3.0 mg/kg或5.0 mg/kg的efzofitimod或安慰劑,每月靜脈注射一次,共12劑。這項研究打算在北美、歐洲和日本的多箇中心招募264名肺結節病患者。試驗設計將納入強制類固醇縮減。這項研究的主要終點是類固醇減少。次要終點包括肺功能和結節病症狀的測量。
More information on the EFZO-FIT study is available at (NCT05415137) and .
有關EFZO-FIT的更多信息研究報告可在(NCT05415137)和。
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.,Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
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