一次情報の記録
決定級トップライン結果
DBVテクノロジーズ:第3相VITESSE試験、VIASKINピーナッツパッチが主要評価項目を達成
The VITESSE Phase 3 trial met its primary endpoint with a statistically significant treatment effect (p<0.001) showing 46.6% responders vs 14.8% placebo. Additional data presented at AAAAI 2026 demonstrate consistent desensitization across baseline eliciting dose strata and confirm the robustness of the primary analysis. The company plans to submit a BLA to FDA in the first half of this year.
主要事実
- 提出
- 2026年3月2日 12:54
- イベント
- トップライン結果
- 方向
- ポジティブ
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- p値
- p<0.001
- CI下限
- 24.5%
- 差
- 31.8%
- 登録数
- 654例
- 奏効率
- 46.6% vs 14.8%
- アナフィラキシー発生率
- 0.5%
- 中止率
- 3.2% vs 0.5%
出典の抜粋
EX-99.1 2 d110966dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting • Approximately 83% of children treated with the VIASKIN ® Peanut Patch increased their eliciting dose at month 12, compared to approximately 48% in the placebo group • Approximately 60% of children treated with the VIASKIN ® Peanut Patch increased their eliciting dose by at least two doses at month 12, compared to 23% in the placebo group • 24% of children on placebo decreased their eliciting dose between the baseline and month 12 double-blind, placebo-controlled food challenge, compared to only 6.4% of children treated with the VIASKIN ® Peanut Patch DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasd