Aldeyra Therapeutics Inc ALDX launched topline outcomes from a Part 2 medical trial of ADX-629, an investigational RASP modulator, in sufferers with atopic dermatitis.
Relative to baseline, the medical trial demonstrated statistically important and clinically related enchancment in investigator-assessed and patient-reported outcomes, together with full decision of affected physique floor space noticed in a single affected person and elimination of itching reported by two sufferers.
EASI thresholds for 50% enchancment (EASI‑50), 75% enchancment (EASI-75), and 90% enchancment (EASI-90) had been met in 4 sufferers (50%), three sufferers (38%), and one affected person (13%), respectively.
Statistical significance was achieved for improved physique floor space; one affected person (13%) achieved full clearance of affected physique floor space.
Statistical significance was achieved for enchancment in IGA.
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The IGA threshold rating of 0 (clear) or 1 (nearly clear) was met in a single (13%) affected person.
Statistical significance was achieved for enchancment in patient-reported itching; the clinically related threshold of enchancment by 4 or extra factors was met in three sufferers (38%), and two sufferers (25%) reported elimination of itching.
Statistical significance was achieved for enchancment in patient-reported eczema severity; the clinically related enchancment threshold by 4 or extra factors was met in six sufferers (75%).
Statistical significance was achieved for enchancment in melancholy (HAM-D, p=0.02), and numerical enchancment was noticed for enchancment in anxiousness (BAI, p=0.1).
No sufferers skilled flare requiring rescue remedy.
Aldeyra expects to provoke a Part 1/2 trial of ADX‑246 in wholesome volunteers and sufferers with atopic dermatitis in 1H of 2024. Topline outcomes are anticipated in 2H of 2024.
Value Motion: ALDX shares are up 15.50% at $3.42 on the final verify Tuesday.
