Quince Therapeutics Presents Safety Data From Prior Phase 3 ATTeST Clinical Trial At 53rd Child Neurology Society Annual Meeting
Quince Therapeutics Presents Safety Data From Prior Phase 3 ATTeST Clinical Trial At 53rd Child Neurology Society Annual Meeting
Quince Therapeutics, Inc. (NASDAQ:QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced the poster presentation at the 53rd Child Neurology Society (CNS) Annual Meeting of safety data from its prior Phase 3 ATTeST (Ataxia-Telangiectasia Trial with the EryDex SysTem; #IEDAT-02-2015/NCT02770807) clinical trial. The objective of the data analysis was to evaluate treatment-emergent adverse events (TEAEs) in patients with Ataxia-Telangiectasia (A-T) treated with the company's lead asset, EryDex (intra-erythrocyte dexamethasone sodium phosphate), for one year compared to placebo control.
Quince Therapeutics, Inc. (納斯達克:QNCX)是一家專注於爲罕見疾病治療解鎖患者自身生物力量的晚期生物技術公司，今天宣佈了在第53屆兒童神經病學學會（CNS）年會上關於其之前第三期ATTeSt（Ataxia-Telangiectasia Trial with the EryDex SysTem; #IEDAt-02-2015/NCT02770807）臨床試驗的安全數據的海報展示。數據分析的目標是評估患有遺傳性顫動血管擴張症（A-T）的患者在接受該公司主力資產EryDex（紅細胞內地塞米松磷酸鈉）治療一年後與安慰劑對照組比較的治療相關不良事件（TEAEs）情況。
Key findings reported in the poster presentation, titled Treatment-Emergent Adverse Events (TEAEs) in Children With Ataxia-Telangiectasia Treated for One Year With Intra-Erythrocyte Dexamethasone Sodium Phosphate (EryDex), include:
在題爲「遺傳性顫動血管擴張症患兒接受紅細胞內地塞米松磷酸鈉（EryDex）治療一年的治療相關不良事件（TEAEs）」的海報展示中報告的關鍵發現包括：
- EryDex treatment was generally well tolerated with most TEAEs being mild to moderate and transient, and generally similar between EryDex- and placebo-treated patients.
- Side effects typically attributed to chronic steroid use, such as Cushingoid features, hyperglycemia, hirsutism, or hypertension, were not observed.
- Three patients were discontinued from the study: one patient in the low-dose group had a serious adverse event (SAE) of B-cell lymphoma (unlikely treatment related) and two patients in the high-dose group had TEAEs of pyrexia and tachycardia (one patient, probably treatment related) and pain and pruritus (one patient, possibly treatment related).
- There were no TEAEs leading to death.
- EryDex治療通常耐受良好，大多數TEAEs爲輕度至中度且短暫，且在EryDex組和安慰劑組患者之間總體相似。
- 通常歸因於慢性類固醇使用的副作用，如庫欣樣特徵、高血糖、多毛症或高血壓，並未觀察到。
- 有三名患者退出研究：低劑量組有一名患者出現嚴重不良事件（SAE）b-細胞淋巴瘤（不太可能與治療有關），高劑量組有兩名患者出現了TEAEs，分別是發熱和心動過速（一名患者，可能與治療有關）以及疼痛和瘙癢（一名患者，可能與治療有關）
- 沒有因TEAEs導致死亡的情況發生。
