Veru Gets FDA Approval to Move Covid-19 Treatment Into Phase 3 Study
Veru Gets FDA Approval to Move Covid-19 Treatment Into Phase 3 Study
DJ Veru Gets FDA Approval to Move Covid-19 Treatment Into Phase 3 Study
By Chris Wack
Veru Inc. said the U.S. Food and Drug Administration agreed in an end of Phase 2 meeting to advance VERU-111 into a Phase 3 registration clinical study.
The biopharmaceutical company said the FDA's move is based on the clinically meaningful benefits observed with VERU-111 treatment in the recently completed Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in 40 hospitalized Covid-19 patients at high risk for ARDS.
Veru said the Phase 2 trial saw clinically meaningful reductions in relevant endpoints, including respiratory failure, patient mortality, days in the ICU and days on mechanical ventilation. VERU-111 could act as an antiviral and an anti-inflammatory agent which is supported by positive Phase 2 clinical study results.
The company said it has met with and will seek funding from The Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, as well as other agencies, to fund the estimated amount of commercial drug to supply the needs of the U.S. population, assuming confirmatory positive Phase 3 clinical results and FDA approval.
Veru shares were up 15% to $15.93 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
March 01, 2021 09:18 ET (14:18 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
DJ Veru Gets FDA Approval to Move Covid-19 Treatment Into Phase 3 Study
DJ Veru獲得美國食品和藥物管理局批准將新冠肺炎治療轉移到第三階段研究
By Chris Wack
克里斯·瓦克(Chris Wack)著
Veru Inc. said the U.S. Food and Drug Administration agreed in an end of Phase 2 meeting to advance VERU-111 into a Phase 3 registration clinical study.
Veru Inc.表示，美國食品和藥物管理局(FDA)在第二階段會議結束時同意將Veru-111提前進入第三階段註冊臨牀研究。
The biopharmaceutical company said the FDA's move is based on the clinically meaningful benefits observed with VERU-111 treatment in the recently completed Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in 40 hospitalized Covid-19 patients at high risk for ARDS.
這家生物製藥公司表示，FDA此舉是基於最近完成的第二階段臨牀試驗中觀察到的VERU-111治療的臨牀意義，該試驗評估了40名住院的新冠肺炎患者中口服VERU-111每天一次的劑量與安慰劑的效果。VERU-111是急性呼吸窘迫綜合徵的高危患者。
Veru said the Phase 2 trial saw clinically meaningful reductions in relevant endpoints, including respiratory failure, patient mortality, days in the ICU and days on mechanical ventilation. VERU-111 could act as an antiviral and an anti-inflammatory agent which is supported by positive Phase 2 clinical study results.
Veru説，第二階段試驗在臨牀上有意義地減少了相關終點，包括呼吸衰竭、患者死亡率、在ICU的天數和機械通氣天數。VERU-111可以作為一種抗病毒和抗炎藥，這一點得到了陽性的第二期臨牀研究結果的支持。
The company said it has met with and will seek funding from The Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, as well as other agencies, to fund the estimated amount of commercial drug to supply the needs of the U.S. population, assuming confirmatory positive Phase 3 clinical results and FDA approval.
該公司表示，它已經與美國衞生與公眾服務部(Department Of Health And Human Services)生物醫學高級研究與發展局(Biomedical Advanced Research And Development Authority)以及其他機構會面，並將尋求資金，以資助估計的商業藥物數量，以滿足美國人口的需求，前提是確診的第三階段臨牀結果呈陽性，並獲得FDA的批准。
Veru shares were up 15% to $15.93 in premarket trading.
Veru股價在盤前交易中上漲15%，至15.93美元。
Write to Chris Wack at chris.wack@wsj.com
寫信給克里斯·瓦克(chris.wack@wsj.com)
(END) Dow Jones Newswires
(完)道瓊通訊社
March 01, 2021 09:18 ET (14:18 GMT)
2021年3月1日09：18美國東部時間(格林尼治標準時間14：18)
Copyright (c) 2021 Dow Jones & Company, Inc.
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譯文內容由第三人軟體翻譯。
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