Bionomics Reveals Detailed Data From PTSD Trial, Stock Soars
Bionomics Reveals Detailed Data From PTSD Trial, Stock Soars
Thursday, Bionomics Limited (NASDAQ:BNOX) released a full dataset analysis from its Phase 2b ATTUNE trial of BNC210 in patients with post-traumatic stress disorder (PTSD).
週四，Bionomics Limited（納斯達克股票代碼：BNOX）發佈了其針對創傷後應激障礙（PTSD）患者的 BNC210 2b 期 ATTUNE 試驗的完整數據集分析。
In September 2023, Bionomics reported the topline results for the Phase 2b ATTUNE trial of BNC210 for PTSD, demonstrating that the trial met its primary endpoint and several secondary endpoints and that BNC210 was generally well tolerated.
2023 年 9 月，Bionomics 報告了 BNC210 治療創傷後應激障礙的 2b 期 ATTUNE 試驗的主要結果，表明該試驗達到了其主要終點和幾個次要終點，而且 BNC210 的耐受性總體良好。
The primary endpoint of mean change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score was met, showing that BNC210 led to a statistically significant improvement vs placebo (p<0.05) at Week 12 with an effect size of 0.40.
在臨床醫生管理的創傷後應激障礙量表中，DSM-5（CAPS-5）總症狀嚴重程度評分與基線相比平均變化的主要終點已經達到，這表明 BNC210 在第12周與安慰劑（p
The improvement in CAPS-5 score was observed as early as Week 4 and continued through Week 8 (p<0.05, effect size 0.44) till the end of the treatment period.
早在第 4 周就觀察到了 CAPS-5 評分的改善，一直持續到第 8 周（p
Additionally, statistically significant results were achieved for negative alterations in cognition and mood at Week 4 and Week 8.
此外，在第4周和第8周認知和情緒的負面變化取得了具有統計學意義的結果。
Treatment with BNC210 led to statistically significant improvement (p<0.05) in the following secondary endpoints: depressive symptoms at Week 12 and sleep at Weeks 4, 8, and 12.
BNC210 治療使以下次要終點出現統計學上的顯著改善（p
BNC210 treatment showed improvement trends (p<0.1) across visits in the other secondary endpoints, including the clinical and patient global impressions severity scales, the Hamilton Anxiety Rating scale, and the Sheehan Disability Scale.
BNC210 治療在其他次要終點的就診量表中顯示出改善趨勢（p
Overall, BNC210 continued to demonstrate a favorable safety profile for a psychoactive experimental therapeutic.
總體而言，BNC210 繼續表現出良好的精神活性實驗療法的安全性。
66.7% of patients in the BNC210 arm and 53.8% in the placebo arm reported at least one treatment-emergent adverse event. Most AEs were mild or moderate. No serious AEs were reported with BNC210.
66.7% 的 BNC210 組患者和安慰劑組的 53.8% 的患者報告了至少一次治療緊急不良事件。大多數 AE 爲輕度或中度。BNC210 未報告嚴重不良反應。
Upon trial completion, no withdrawal symptoms were reported.
試驗完成後，未報告戒斷症狀。
Following the ATTUNE Phase 2b trial readout and based on a safety database of ~600 patients, BNC210 continues to demonstrate a non-sedating, non-habit forming, non-cognition impairing psychoactive profile.
在 ATTUNE 2b 期試驗公佈之後，基於大約 600 名患者的安全數據庫，BNC210 繼續表現出一種不起鎮靜作用、不形成習慣、非認知損害精神活性的特徵。
In addition to the 900 mg twice daily dose, a lower BNC210 dose that may alleviate hepatic enzyme elevations will be tested in a subsequent late-stage clinical trial.
除了每天兩次 900 mg 的劑量外，還將在隨後的後期臨床試驗中測試可能緩解肝酶升高的較低 BNC210 劑量。
Bionomics plans to discuss the Phase 2b ATTUNE results with the FDA in Q2 2024 and proceed to a late-stage trial in the fourth quarter of 2024.
Bionomics計劃在2024年第二季度與美國食品藥品管理局討論2b階段ATTUNE的結果，並在2024年第四季度進行後期試驗。
Price Action: BNOX shares are down 1.09% at $1.03 after reaching as high as $1.30 during the premarket session on Thursday.
價格走勢：BNOX股價在週四盤前交易中跌至1.30美元后，下跌1.09％，至1.03美元。