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Aldeyra Therapeutics Inc (NASDAQ: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.
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. Topline results are expected in 2H of 2024.
Price Action: ALDX shares are up 15.50% at $3.42 on the last check Tuesday.
