Why Is Skin Disease-Focused Q32 Bio Stock Trading Lower On Wednesday?
Why Is Skin Disease-Focused Q32 Bio Stock Trading Lower On Wednesday?
Following database lock, one site was excluded from the efficacy analysis based on marked protocol violations of entry criteria, resulting in the removal of three placebo patients.On Wednesday, Q32 Bio Inc. (NASDAQ:QTTB) revealed topline results from the SIGNAL-AA Phase 2a signal finding trial evaluating bempikibart (ADX-914) for alopecia areata (AA).
在週三，Q32 Bio Inc.（納斯達克：QTTB）公佈了SIGNAL-AA 2a期信號發現試驗的頂線結果，該試驗評估了用於斑禿（AA）的bempikibart（ADX-914）。
The company plans to expand the SIGNAL-AA Phase 2a clinical trial and enroll additional patients evaluating bempikibart in AA.
該公司計劃擴展SIGNAL-AA 2a期臨床試驗，並招募額外的患者以評估bempikibart在AA中的效果。
The company said the trial did not meet its primary endpoint in Part B. Q32 Bio plans to review the results.
公司表示，該試驗在B部分未達到其主要終點。Q32 Bio計劃審查結果。
Following database lock, one site was excluded from the efficacy analysis based on marked protocol violations of entry criteria, resulting in the removal of three placebo patients.
在數據庫鎖定後，因明顯違反入組標準的協議，一處試驗站點被排除在療效分析之外，導致三名安慰劑患者被移除。
Due to the reduced sample size, the planned statistical analyses for the primary endpoint were rendered inappropriate.
由於樣本量減少，計劃中的主要終點統計分析變得不適用。
On a post-hoc analysis of the remaining per-protocol population of patients with AA (n=27), bempikibart demonstrated an improvement in hair regrowth compared to placebo:
在對剩餘的按協議人群進行事後分析後（n=27），bempikibart相較於安慰劑顯示出頭髮生長的改善：
- At week 24: patients treated with bempikibart showed a mean reduction in baseline Severity of Alopecia Tool (SALT) score of 16% in the bempikibart group vs a reduction of 2% in the placebo group.
- At week 24: 9% of bempikibart patients in the trial achieved a SALT-20 (SALT score less than or equal to 20) compared to 0% in placebo.
- At week 26: 13% of bempikibart patients achieved SALT-20 compared to 0% in placebo.
- 在第24周：接受bempikibart治療的患者在bempikibart組的基礎上，斑禿嚴重程度工具（SALT）評分平均下降了16%，而安慰劑組下降了2%。
- 在第24周：9%的bempikibart患者在試驗中達到了SALT-20（SALT評分小於或等於20），而安慰劑組爲0%。
- 在第26周：13%的bempikibart患者達到了SALt-20，而安慰劑組則爲0%。
Bempikibart was observed to be safe and well-tolerated in the SIGNAL-AA trial. There were no serious adverse events (SAE) or Grade 3 or higher adverse events related to treatment.
在SIGNAL-AA試驗中觀察到bempikibart是安全且耐受良好的。沒有與治療相關的嚴重不良事件（SAE）或3級及以上的不良事件。
Q32 Bio plans to enroll approximately 20 additional patients in a Part B expansion of the SIGNAL-AA Phase 2a trial to evaluate bempikibart in AA, including a loading regimen.
Q32 Bio計劃在SIGNAL-AA 2a期試驗的b部分擴展中招募大約20名額外患者，以評估bempikibart在AA中的效果，包括加載方案。
The company will defer enrollment into the planned Phase 2 trial of ADX-097 in ANCA-Associated Vasculitis (AAV), previously expected to begin in 2025, to focus efforts on continued enrollment in the ongoing bempikibart AA and ADX-097 renal basket Phase 2 clinical trials.
該公司將推遲原計劃於2025年開始的ADX-097在抗中性粒細胞胞漿抗體（ANCA）相關血管炎（AAV）中的2期試驗入組，集中精力繼續招募進行中的bempikibart AA和ADX-097腎臟組合2期臨床試驗。
The company also provided an update on the SIGNAL-AD clinical trial in patients with atopic dermatitis (AD).
該公司還提供了有關特應性皮炎（AD）患者的SIGNAL-AD臨床試驗的最新信息。
In Part A, at week 14, the average EASI (eczema) score improvement from baseline was 58% in patients treated with 2mg/kg Q2W SC, 84% in patients treated at 3mg/kg Q2W SC, and 72% on a pooled basis, compared to 38% in patients treated with placebo.
在A部分中，在第14周，接受每兩週一次2mg/kg SC治療的患者平均EASI（溼疹）評分改善58%，接受每兩週一次3mg/kg SC治療的患者改善84%，整體 pooled 基本爲72%，而安慰劑組的患者改善僅爲38%。
Part B evaluated the efficacy and safety of bempikibart compared to the placebo.
B部分評估了bempikibart與安慰劑相比的療效和安全性。
The primary endpoint is the mean percent change in the Eczema Area and Severity Index (EASI) score from baseline to week 14.
主要終點是溼疹面積和嚴重程度指數（EASI）評分從基線到第14周的平均百分比變化。
At week 14, data from Part B demonstrated that patients treated with bempikibart showed a 74% improvement in average EASI from baseline, compared to 76% for the placebo group (p= not statistically significant).
在第14周，b部分的數據表明，接受bempikibart治療的患者平均EASI較基線改善了74%，而安慰劑組爲76%（p=無統計學意義）。
Across SIGNAL-AD and SIGNAL-AA, bempikibart at 200mg Q2W SC demonstrated favorable PK and target engagement as demonstrated by substantial reductions in biomarkers of Th2 and Th1.
在SIGNAL-AD和SIGNAL-AA研究中，200mg Q2W SC的bempikibart表現出良好的藥代動力學和靶點參與，表現爲Th2和Th1生物標誌物顯著減少。
Price Action: QTTB stock is down 67.1% at $8.04 at last check Wednesday.
價格走勢：QTTb股票上週三最後檢查時下跌67.1%，報8.04美元。
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