Aldeyra: Drug candidate ADX-629 trial improved signs of intoxication in Alcohol

Aldeyra Therapeutics announced demonstration of target engagement and improvement in the signs of alcohol intoxication in a sequence-randomized, double-masked, placebo-controlled crossover Phase 2 clinical trial of ADX-629, a first-in-class orally administered investigational new drug candidate. Relative to placebo, ADX-629 reduced dermal flushing , increased Romberg test balance time , and lowered levels of the ethanol RASP metabolite acetaldehyde following acute exposure to alcohol. "The evidence of activity of ADX-629 following acute alcohol intoxication is encouraging given the paucity of treatment options for patients with alcohol-associated liver diseases," stated Loretta L. Jophlin, M.D., Ph.D., Assistant Professor of Medicine at the University of Louisville. "For patients with moderate alcohol-associated hepatitis, standard of care is generally observation, and thus there is demand for potential new therapies such as ADX-629 that could prevent disease progression or otherwise improve outcomes." " "With unparalleled expertise in the discovery and development of drug product candidates that target RASP, we remain committed to bringing to market a novel pharmacology to address unmet medical need." Based on the results of the alcohol challenge clinical trial, Aldeyra plans to support an investigator-sponsored Phase 2 clinical trial of ADX-629 in moderate alcoholic hepatitis. The trial is expected to be initiated in 2023. Results from a Phase 2 clinical trial of ADX-629 in chronic cough are expected in the first half of 2023, and results from Phase 2 clinical trials of ADX-629 in minimal change disease and Sjogren-Larsson Syndrome are expected in 2023.