Aldeyra Therapeutics Provides Clinical and Regulatory Update and Announces Advancement of RASP Platform in Systemic and Retinal Inflammatory Diseases - Seite 2

Moderate alcoholic hepatitis is a common disease that leads to significant morbidity and mortality due to hepatic compromise and related complications. There is no FDA-approved therapy for alcoholic hepatitis. In preclinical models of ethanol toxicity, ADX-629 decreased hepatic levels of RASP, triglycerides, and inflammatory cytokines. In a sequence-randomized, double-masked, placebo-controlled crossover Phase 2 clinical trial announced last year, relative to placebo, ADX-629 reduced dermal flushing (P=0.0007), increased Romberg test balance time (P=0.02), and lowered levels of the ethanol RASP metabolite acetaldehyde (P=0.03) following acute exposure to alcohol. The moderate alcoholic hepatitis Phase 2 clinical trial is intended to assess the activity of ADX-629, administered orally twice daily over 90 days, initially in approximately 10 patients. The primary endpoint is safety and tolerability; secondary endpoints include liver function biomarkers, model for end-stage liver disease (MELD) score, hospitalization, and mortality rate. Top-line results from the first patient cohort are expected in the second half of 2024.

Atopic dermatitis is a common disease characterized by immune dysregulation that leads to hyperreactivity to endogenous and exogenous factors, potentially including RASP. There is no widely accepted oral therapy for the treatment of patients with mild to moderate atopic dermatitis. Recently announced results from a 90-day, open-label Phase 2 clinical trial of orally administered ADX-629 in eight mild to moderate atopic dermatitis patients demonstrated statistically significant and clinically relevant improvement in investigator-assessed and patient-reported outcomes across a number of different physiological and psychosocial assessments, including complete resolution of affected body surface area observed in one patient and elimination of itching reported by two patients. Based on the results of the clinical trial, an IND application of next-generation investigational RASP modulator ADX-246 for a Phase 1 clinical trial in healthy volunteers has been submitted to the FDA and is expected to be expanded to include clinical testing in patients with atopic dermatitis. The clinical trial is anticipated to be initiated in the first half of 2024, and top-line results are expected in the second half of 2024.