<p><strong>DBV Technologies S.A</strong>. (NASDAQ: DBVT) 周二发布了 VITESSE 第三阶段研究的数据，该研究评估了 VIASKIN 花生贴片对 4 至 7 岁花生过敏儿童的安全性和有效性。</p>
<ul>
<li><strong><em>DBV Technologies 股票正在挑战阻力位。是什么推动 DBVT 创下新高？</em></strong></li>
</ul>
<h2>试验数据</h2>
<p>关键试验 达到了其主要终点。</p>
<p>VIASKIN 花生显示出统计学上显著的治疗效果，在 VIASKIN 花生组中，46.6% 的儿童在 12 个月后符合治疗反应者标准，而在安慰剂组中仅有 14.8%。</p>
<p><strong><em>另请阅读：RFK Jr 拒绝早期接触理论，称铝基疫苗是花生过敏上升的原因</em></strong></p>
<p>反应者被定义为基线诱发剂量 (ED) ≤30 毫克的儿童，在第 12 个月时达到 ED ≥300 毫克的花生蛋白，或基线 ED = 100 毫克的儿童在第 12 个月时达到 ED ≥600 毫克的花生蛋白，测量方法为双盲安慰剂对照食物挑战 (DBPCFC)。</p>
<p>ED 是 诱发过敏反应的花生蛋白量。</p>
<p>VITESSE 招募了 654 名儿童，超过了最初的 600 名招募目标，其中 438 名和 216 名分别被随机分配到活性组和安慰剂组。</p>
<p>安全性结果与迄今为止 VIASKIN 花生临床项目的安全性特征一致。</p>
<p>在 VITESSE 研究中观察到的最常见的治疗出现的不良事件 (TEAEs) 是在贴片应用部位的轻度至中度局部皮肤反应。</p>
<p>由于 TEAEs 而中止治疗的比例在治疗组为 3.2%，而在安慰剂组为 0.5%。</p>
<p>没有报告与治疗相关的严重不良事件，治疗相关的过敏性反应发生率低至 0.5%（n=2）——这两名儿童继续接受治疗。</p>
<p>该公司表示，探索性粘附评估的数据符合其预期。</p>
<p>总体依从性高达 96.2%，与其他第三阶段 VIASKIN 花生研究中观察到的情况一致。</p>
<h2>接下来会怎样？</h2>
<p>DBV 正在推进计划，计划在 2026 年上半年向美国提交生物制品许可申请 (BLA)。</p>
<p><strong>DBVT 价格动态：</strong> 周二，DBV Technologies 的股票在盘前交易中上涨 35.76%，报 $24.41。该股票交易价格创下 52 周新高，根据 Benzinga Pro 数据。</p>
<p><strong>下一步阅读：</strong></p>
<ul>
<li><strong><em>Palantir 与 Accenture 联手扩展企业 AI</em></strong></li>
</ul>
<p><em>照片来源于 Shutterstock</em></p>

DBV 科技

<p>DBV 科技报告其 VIASKIN 花生贴片的第三阶段试验结果积极，显示在治疗 4 至 7 岁儿童的花生过敏方面具有显著疗效。该试验达到了其主要终点，46.6% 的儿童对治疗产生了反应。公司计划在 2026 年提交美国生物制品许可申请（BLA）。DBV 科技的股票上涨了 35.76%，达到了 52 周高点</p>

<p><strong>DBV Technologies S.A</strong>. (NASDAQ: DBVT) on Tuesday released data from the VITESSE Phase 3 study assessing the safety and efficacy of VIASKIN Peanut patch for peanut-allergic children aged 4 to 7 years.</p>
<div class="lb-trans"><p><strong>DBV Technologies S.A</strong>. (NASDAQ: DBVT) 周二发布了 VITESSE 第三阶段研究的数据，该研究评估了 VIASKIN 花生贴片对 4 至 7 岁花生过敏儿童的安全性和有效性。</p>
</div><ul>
<li><strong><em>DBV Technologies stock is challenging resistance. What’s driving DBVT to record levels?</em></strong></li>
</ul>
<div class="lb-trans"><ul>
<li><strong><em>DBV Technologies 股票正在挑战阻力位。是什么推动 DBVT 创下新高？</em></strong></li>
</ul>
</div><h2>Trial Data</h2>
<div class="lb-trans"><h2>试验数据</h2>
</div><p>The pivotal trial met its primary endpoint.</p>
<div class="lb-trans"><p>关键试验 达到了其主要终点。</p>
</div><p>VIASKIN Peanut demonstrated a statistically significant treatment effect, with 46.6% of children in the VIASKIN Peanut arm meeting the treatment responder criteria after 12 months, as compared to 14.8% of children in the placebo arm.</p>
<div class="lb-trans"><p>VIASKIN 花生显示出统计学上显著的治疗效果，在 VIASKIN 花生组中，46.6% 的儿童在 12 个月后符合治疗反应者标准，而在安慰剂组中仅有 14.8%。</p>
</div><p><strong><em>Also Read: RFK Jr Rejects Early Exposure Theory On Rising Peanut Allergies, Says Aluminum-Based Vaccines Are The Reason</em></strong></p>
<div class="lb-trans"><p><strong><em>另请阅读：RFK Jr 拒绝早期接触理论，称铝基疫苗是花生过敏上升的原因</em></strong></p>
</div><p>Responders were defined as children with a baseline eliciting dose (ED) ≤30 mg who achieved an ED ≥300 mg of peanut protein at month 12, or a child with a baseline ED = 100 mg who achieved an ED ≥600 mg of peanut protein at month 12, as measured by a double-blind, placebo-controlled food challenge (DBPCFC).</p>
<div class="lb-trans"><p>反应者被定义为基线诱发剂量 (ED) ≤30 毫克的儿童，在第 12 个月时达到 ED ≥300 毫克的花生蛋白，或基线 ED = 100 毫克的儿童在第 12 个月时达到 ED ≥600 毫克的花生蛋白，测量方法为双盲安慰剂对照食物挑战 (DBPCFC)。</p>
</div><p>The ED is the amount of peanut protein that induced an allergic reaction.</p>
<div class="lb-trans"><p>ED 是 诱发过敏反应的花生蛋白量。</p>
</div><p>VITESSE enrolled 654 children, exceeding its original enrollment target of 600, of which 438 and 216 were randomized to the active and placebo arms, respectively.</p>
<div class="lb-trans"><p>VITESSE 招募了 654 名儿童，超过了最初的 600 名招募目标，其中 438 名和 216 名分别被随机分配到活性组和安慰剂组。</p>
</div><p>Safety results were consistent with the safety profile of the VIASKIN Peanut clinical program to date.</p>
<div class="lb-trans"><p>安全性结果与迄今为止 VIASKIN 花生临床项目的安全性特征一致。</p>
</div><p>The most common treatment-emergent adverse events (TEAEs) observed during the VITESSE study were mild-to-moderate local skin reactions at the patch application site.</p>
<div class="lb-trans"><p>在 VITESSE 研究中观察到的最常见的治疗出现的不良事件 (TEAEs) 是在贴片应用部位的轻度至中度局部皮肤反应。</p>
</div><p>Discontinuations due to TEAEs were low at 3.2% in the treatment arm compared to 0.5% in the placebo arm.</p>
<div class="lb-trans"><p>由于 TEAEs 而中止治疗的比例在治疗组为 3.2%，而在安慰剂组为 0.5%。</p>
</div><p>There were no reports of treatment-related serious adverse events, and treatment-related anaphylaxis was low at 0.5% (n=2) – both children continued treatment.</p>
<div class="lb-trans"><p>没有报告与治疗相关的严重不良事件，治疗相关的过敏性反应发生率低至 0.5%（n=2）——这两名儿童继续接受治疗。</p>
</div><p>The company said data from the exploratory adhesion assessments were in line with its expectations.</p>
<div class="lb-trans"><p>该公司表示，探索性粘附评估的数据符合其预期。</p>
</div><p>Overall, compliance was high at 96.2%, consistent with what has been observed in other Phase 3 VIASKIN Peanut studies.</p>
<div class="lb-trans"><p>总体依从性高达 96.2%，与其他第三阶段 VIASKIN 花生研究中观察到的情况一致。</p>
</div><h2>What Next?</h2>
<div class="lb-trans"><h2>接下来会怎样？</h2>
</div><p>DBV is moving forward with plans for a Biologics License Application (BLA) submission in the United States in the first half of 2026.</p>
<div class="lb-trans"><p>DBV 正在推进计划，计划在 2026 年上半年向美国提交生物制品许可申请 (BLA)。</p>
</div><p><strong>DBVT Price Action:</strong> DBV Technologies shares were up 35.76% at $24.41 during premarket trading on Tuesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.</p>
<div class="lb-trans"><p><strong>DBVT 价格动态：</strong> 周二，DBV Technologies 的股票在盘前交易中上涨 35.76%，报 $24.41。该股票交易价格创下 52 周新高，根据 Benzinga Pro 数据。</p>
</div><p><strong>Read Next:</strong></p>
<div class="lb-trans"><p><strong>下一步阅读：</strong></p>
</div><ul>
<li><strong><em>Palantir, Accenture Team Up To Scale Enterprise AI</em></strong></li>
</ul>
<div class="lb-trans"><ul>
<li><strong><em>Palantir 与 Accenture 联手扩展企业 AI</em></strong></li>
</ul>
</div><p><em>Photo via Shutterstock</em></p>
<div class="lb-trans"><p><em>照片来源于 Shutterstock</em></p>
</div>

DBV 科技推进 FDA 申请：花生过敏贴片是否适用于儿童？