一次情報の記録
重要申請受理
Wave Life Sciences: FDAがWVE-007のPhase 2a INLIGHTを受理
FDAは、BMI 35-50 kg/m²の2型糖尿病の有無にかかわらずの個人を対象としたWVE-007のINLIGHT試験のPhase 2a多回投与部分を受理した。プラセボ対照試験はQ2 2026に開始予定で、12ヶ月間にわたって体組成、肝脂肪、HbA1cおよびその他の心代謝バイオマーカーを評価する。
主要事実
出典の抜粋
EX-99.1 2 d135689dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Wave Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Update With recent FDA acceptance of the Phase 2a multidose portion of INLIGHT trial of WVE-007 (INHBE GalNAc-siRNA) in individuals with higher BMI, with and without type 2 diabetes, this portion of the trial remains on track to initiate in 2Q 2026 Combination and maintenance trials of WVE-007 on track to initiate in 2026 Data from RestorAATion-2 trial of WVE-006 (GalNAc-RNA editing) in AATD (including 400 mg monthly dose and 600 mg single dose cohorts) to be presented at an investor webcast during the ATS International Conference in May 2026 Regulatory feedback on accelerated approval pathway for WVE-006 continues to be expected mid-2026 CTA su