Edesa Biotech Shares Drop 21% After Doubling Monday
Edesa Biotech Shares Drop 21% After Doubling Monday
By Chris Wack
克里斯·瓦克(Chris Wack)著
Edesa Biotech Inc. shares were down 21% to $9.47 one day after the company said it saw positive results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized Covid-19 patients.
艾德薩生物科技公司(Edesa Biotech Inc.)股價下跌21%，至9.47美元，此前該公司表示，正在進行的一項2/3期臨牀研究的第二階段結果呈陽性，該研究正在評估該公司的單克隆抗體候選藥物EB05，用於住院的新冠肺炎患者的單劑治療。
Volume for the stock, which doubled Monday, was 16.1 million shares at 12:45 p.m. ET, compared with its 65-day average volume of 2.5 million shares. The stock has a public float of 7.4 million shares outstanding, and hit its 52-week high of $12 Monday.
截至中午12點45分，該股成交量為1,610萬股，週一翻了一番。美國東部時間，相比之下，其65天平均成交量為250萬股。該股公開流通股為740萬股，週一觸及52周高點12美元。
The biopharmaceutical company said an Independent Data and Safety Monitoring Board informed the company that during its initial analysis of the Phase 2 portion of the study, they identified an important signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded.
這家生物製藥公司表示，獨立數據和安全監測委員會(Independent Data And Safety Monitoring Board)通知該公司，在對該研究第二階段部分的初步分析中，他們發現了治療武器之間對28天死亡率的一個重要信號，並要求該研究先發制人地不盲目。
While the Phase 2 portion was primarily designed to refine patient stratification and statistical powering for the Phase 3 study, the DSMB concluded that a "clinically important efficacy signal" was detected and that the study has met its objective, the company said. The DSMB further recommended continuation of the study into a Phase 3 confirmatory trial.
該公司表示，雖然第二階段的設計主要是為了完善第三階段研究的患者分層和統計賦權，但DSMB的結論是檢測到了“臨牀上重要的療效信號”，該研究已經達到了其目標。DSMB進一步建議將這項研究繼續進行到第三階段驗證性試驗。
Among the findings, the DSMB reported a 28-day death rate of 14.3% in the EB05 arm versus 36.8% in the placebo arm in critically severe patients on extracorporeal membrane oxygenation therapy.
在研究結果中，DSMB報告説，在接受體外膜氧合治療的危重患者中，EB05組的28天死亡率為14.3%，而安慰劑組為36.8%。
Edesa said the results from the Phase 2 analysis also suggest that EB05 has been generally well-tolerated and consistent with the observed safety profile to date. In addition, the DSMB identified another patient group with robust signals for mortality reduction at 28 days and the company plans to review this data as well as the full dataset.
Edesa説，第二階段分析的結果還表明，到目前為止，EB05總體上耐受性良好，與觀察到的安全狀況一致。此外，DSMB確定了另一組患者，他們有強有力的信號可以在28天內降低死亡率，該公司計劃審查這些數據以及完整的數據集。
Edesa said it now plans to focus on patient segments that have demonstrated the strongest efficacy signals and have the greatest potential of rapidly completing enrollment, beginning with critically severe patients. The company intends to file amendments with regulators in the U.S., Canada and Colombia to update the Phase 3 protocol and set targeted enrollment. Edesa said it also is evaluating opportunities to apply for expedited regulatory review programs in the U.S. and Canada.
EDESA表示，它現在計劃將重點放在那些顯示出最強療效信號並具有最大潛力迅速完成登記的患者部分，從危重患者開始。該公司打算向美國、加拿大和哥倫比亞的監管機構提交修正案，以更新第三階段協議，並設定有針對性的註冊。Edesa説，它還在評估在美國和加拿大申請加快監管審查計劃的機會。
Write to Chris Wack at chris.wack@wsj.com
寫信給克里斯·瓦克(chris.wack@wsj.com)
譯文內容由第三人軟體翻譯。