Wave Life Sciences Touts Positive Update From Its Lead Huntington's Program
Wave Life Sciences Touts Positive Update From Its Lead Huntington's Program
浪潮生命科學公司吹捧其牽頭的亨廷頓計劃的積極更新
- Wave Life Sciences Ltd (NASDAQ:WVE) announced an update to the ongoing Phase 1b/2a SELECT-HD trial of WVE-003 for Huntington's disease (HD).
- Eighteen (18) participants have been dosed in the SELECT-HD trial.
- Single doses of WVE-003 up to 90 mg appeared generally safe and well-tolerated.
- Among participants in the 30 and 60 mg WVE-003 cohorts, the mean reduction in CSF mHTT from baseline was 22% (median reduction of 30%) at 85 days following a single dose.
- Related: Ahead Of Upcoming Data On Three Programs, Analysts Remain On Sidelines For Wave Life Sciences.
- In the 30 and 60 mg cohorts, wtHTT protein was preserved, which appears consistent with allele-selectivity.
- Increases in neurofilament light chain (NfL) from baseline were observed in some participants. Wave will continue to monitor trends in NfL as SELECT-HD advances.
- There were no clinically meaningful elevations in CSF white blood cell counts or protein indicating inflammation in the CNS.
- There were no meaningful changes in clinical outcome measures, although the dataset and duration were insufficient to assess clinical effects.
- Based on these data, Wave is adapting the SELECT-HD trial to expand the single-dose cohorts and will also continue advancing the 90 mg cohort for biomarker analysis at day 85.
- Additional single dose biomarker and safety data are expected in the first half of 2023.
- Price Action: WVE shares are up 1.47% at $3.44 on the last check Tuesday.
- Wave Life Sciences Ltd (NASDAQ:WVE) announced an update to the ongoing Phase 1b/2a SELECT-HD trial of WVE-003 for Huntington's disease (HD).
- Eighteen (18) participants have been dosed in the SELECT-HD trial.
- Single doses of WVE-003 up to 90 mg appeared generally safe and well-tolerated.
- Among participants in the 30 and 60 mg WVE-003 cohorts, the mean reduction in CSF mHTT from baseline was 22% (median reduction of 30%) at 85 days following a single dose.
- Related: Ahead Of Upcoming Data On Three Programs, Analysts Remain On Sidelines For Wave Life Sciences.
- In the 30 and 60 mg cohorts, wtHTT protein was preserved, which appears consistent with allele-selectivity.
- Increases in neurofilament light chain (NfL) from baseline were observed in some participants. Wave will continue to monitor trends in NfL as SELECT-HD advances.
- There were no clinically meaningful elevations in CSF white blood cell counts or protein indicating inflammation in the CNS.
- There were no meaningful changes in clinical outcome measures, although the dataset and duration were insufficient to assess clinical effects.
- Based on these data, Wave is adapting the SELECT-HD trial to expand the single-dose cohorts and will also continue advancing the 90 mg cohort for biomarker analysis at day 85.
- Additional single dose biomarker and safety data are expected in the first half of 2023.
- Price Action: WVE shares are up 1.47% at $3.44 on the last check Tuesday.
- 浪潮生命科學有限公司納斯達克:WVE)宣佈了正在進行的WVE-003治療亨廷頓病(HD)的1b/2a期SELECT-HD試驗的最新版本。
- 在SELECT-HD試驗中,18(18)名參與者服用了劑量。
- 單次劑量高達90毫克的WVE-003似乎總體上是安全的,耐受性良好。
- 在30和60毫克WVE-003隊列的參與者中,在單次服藥後85天,腦脊液mHTT較基線平均下降22%(中位數下降30%)。
- 相關: 在三個項目即將公佈數據之前,分析師仍對浪潮生命科學持觀望態度.
- 在30和60 mg的隊列中,wtHTT蛋白被保留,這與等位基因的選擇性一致。
- 在一些參與者中觀察到神經絲輕鏈(NFL)較基線有所增加。隨着SELECT-HD的發展,WAVE將繼續監測NFL的趨勢。
- 腦脊液中白細胞計數或蛋白質水平的升高沒有臨牀意義,表明中樞神經系統有炎症反應。
- 雖然數據集和持續時間不足以評估臨牀效果,但臨牀結果指標沒有顯著變化。
- 基於這些數據,Wave正在調整SELECT-HD試驗,以擴大單劑量隊列,並將在第85天繼續推進用於生物標記物分析的90 mg隊列。
- 預計2023年上半年將有更多的單劑量生物標記物和安全性數據。
- 價格行動:WVE股價週二尾盤上漲1.47%,至3.44美元。
譯文內容由第三人軟體翻譯。
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我知道了
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