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Loading...Loading...Aldeyra Therapeutics Inc ALDX released topline results from a Phase 2 clinical trial of ADX-629, an investigational RASP modulator, in patients with atopic dermatitis. Relative to baseline, the clinical trial demonstrated statistically significant and clinically relevant improvement in investigator-assessed and patient-reported outcomes, including complete resolution of affected body surface area observed in one patient and elimination of itching reported by two patients.EASI thresholds for 50% improvement (EASI‑50), 75% improvement (EASI-75), and 90% improvement (EASI-90) were met in four patients (50%), three patients (38%), and one patient (13%), respectively.Statistical significance was achieved for improved body surface area; one patient (13%) achieved complete clearance of affected body surface area. Statistical significance was achieved for improvement in IGA. Also Read: FDA Rejects Aldeyra Therapeutics' Dry Eye Disease Candidate, Asks For Additional Study..
正在加载。。。正在加载。。。Aldeyra Therapeutics Inc ALDX发布了ADX-629(一种研究性RASP调节剂)在特应性皮炎患者中的2期临床试验的topline结果。相对于基线,临床试验显示研究者评估和患者报告的结果在统计学上显着且临床相关的改善,包括在一名患者中观察到的受影响体表面积的完全消退和两名患者报告的瘙痒的消除。四名患者(50%),三名患者(38%)和一名患者(13%)分别达到了50%改善(EASI-50),75%改善(EASI-75)和90%改善(EASI-90)的EASI阈值。改善体表面积具有统计学意义;一名患者(13%)完全清除了受影响的体表区域。IGA的改善具有统计学意义。另请阅读:FDA拒绝Aldeyra Therapeutics的干眼症候选人,要求进一步研究。。
The IGA threshold score of 0 (clear) or 1 (almost clear) was met in one (13%) patient. Statistical significance was achieved for improvement in patient-reported itching; the clinically relevant threshold of improvement by 4 or more points was met in three patients (38%), and two patients (25%) reported elimination of itching. Statistical significance was achieved for improvement in patient-reported eczema severity; the clinically relevant improvement threshold by 4 or more points was met in six patients (75%). Statistical significance was achieved for improvement in depression (HAM-D, p=0.02), and numerical improvement was observed for improvement in anxiety (BAI, p=0.1).No patients experienced flare requiring rescue therapy. Aldeyra expects to initiate a Phase 1/2 trial of ADX‑246 in healthy volunteers and patients with atopic dermatitis in 1H of 2024.
一名(13%)患者的IGA阈值得分为0(清晰)或1(几乎清晰)。患者报告的瘙痒改善具有统计学意义;三名患者(38%)达到了4分或更多分的临床相关改善阈值,两名患者(25%)报告消除了瘙痒。患者报告的湿疹严重程度有所改善,具有统计学意义;六名患者(75%)达到了4分或更多分的临床相关改善阈值。抑郁症改善有统计学意义(HAM-D,p=0.02),焦虑改善有数值改善(BAI,p=0.1)。没有患者出现需要抢救治疗的眩晕。Aldeyra预计将于2024年上半年在健康志愿者和特应性皮炎患者中启动ADX-246的1/2期试验。
Topline results are expected in 2H of 2024.Price Action: ALDX shares are up 15.50% at $3.42 on the last check Tuesday.Loading...Loading....
预计2024年下半年将公布业绩。价格走势:周二最后一次检查时,ALDX股价上涨15.50%,至3.42美元。正在加载。。。正在加载。。。。