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获得美国食品和药物管理局批准将新冠肺炎治疗转移到第三阶段研究
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，美国食品和药物管理局(FDA)在第二阶段会议结束时同意将Veru-111提前进入第三阶段注册临床研究。
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.
这家生物制药公司表示，FDA此举是基于最近完成的第二阶段临床试验中观察到的VERU-111治疗的临床意义，该试验评估了40名住院的新冠肺炎患者中口服VERU-111每天一次的剂量与安慰剂的效果。VERU-111是急性呼吸窘迫综合征的高危患者。
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说，第二阶段试验在临床上有意义地减少了相关终点，包括呼吸衰竭、患者死亡率、在ICU的天数和机械通气天数。VERU-111可以作为一种抗病毒和抗炎药，这一点得到了阳性的第二期临床研究结果的支持。
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.
该公司表示，它已经与美国卫生与公众服务部(Department Of Health And Human Services)生物医学高级研究与发展局(Biomedical Advanced Research And Development Authority)以及其他机构会面，并将寻求资金，以资助估计的商业药物数量，以满足美国人口的需求，前提是确诊的第三阶段临床结果呈阳性，并获得FDA的批准。
Veru shares were up 15% to $15.93 in premarket trading.
Veru股价在盘前交易中上涨15%，至15.93美元。
Write to Chris Wack at chris.wack@wsj.com
写信给克里斯·瓦克(chris.wack@wsj.com)
(END) Dow Jones Newswires
(完)道琼通讯社
March 01, 2021 09:18 ET (14:18 GMT)
2021年3月1日09：18美国东部时间(格林尼治标准时间14：18)
Copyright (c) 2021 Dow Jones & Company, Inc.
版权所有(C)2021年道琼斯公司
译文内容由第三方软件翻译。
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