一次情報の記録
決定級試験登録の変更
Upstream Bio、vereKitugの重症喘息およびCRSwNPを対象とした第3相試験計画を発表
FDAとのEnd-of-Phase 2ミーティング終了後、Upstream Bioはバイオマーカー制限のない幅広い集団を対象に、12週ごとに400 mgの単回皮下投与を用いたプラセボ対照第3相試験を各適応症で1件実施する予定です。両試験は2027年第1四半期に開始予定で、喘息試験では48週時点のAAERを、CRSwNP試験では48週時点のNPSおよびNCSを主要評価項目とします。
主要事実
出典の抜粋
EX-99.1 2 upb-ex99_1.htm EX-99.1 EX-99.1 Upstream Bio Announces Pivotal Phase 3 Development Plans for Verekitug in Both Severe Asthma and CRSwNP – Following productive FDA discussions, Upstream Bio will study 400mg of verekitug administered every 12 weeks, versus placebo, in severe asthma and CRSwNP with one pivotal Phase 3 trial in each indication – – The Company’s Phase 3 strategy is designed to deliver best-in-class efficacy across both indications by evaluating a high-dose, quarterly regimen of verekitug in broad patient populations – – The Company remains on track to initiate both Phase 3 trials in Q1 2027 – WALTHAM, Mass. – September 1, 2026 - Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for severe inflammatory respiratory diseases, today ann