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Aldeyra Therapeutics’ Investigational RASP Modulator ADX-629 Improved Signs of Intoxication in Alcohol Challenge Phase 2 Clinical Trial
Relative to Placebo, ADX-629 Reduced Dermal Flushing (P=0.0007), Increased Romberg Test Balance Time (P=0.02), and Lowered Levels of Acetaldehyde (P=0.03)
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\nRelative to Placebo, ADX-629 Reduced Dermal Flushing (P=0.0007), Increased Romberg Test Balance Time (P=0.02), and Lowered Levels of Acetaldehyde (P=0.03) Following Exposure to Alcohol\n\nAldeyra Plans to Support Investigator-Sponsored Phase 2 Clinical Trial of ADX-629 in Moderate Alcoholic Hepatitis, Expected to be Initiated in 2023\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today 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 (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.\n\n“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.”\n\nADX-629 or placebo was administered twice before exposure to alcohol and once afterwards. Post-baseline assessments occurred when target blood alcohol concentrations were reached and again over the following day. Assessments included proprioception tests, flushing, symptoms, and plasma laboratory markers. Of the 25 subjects who were randomized, 23 subjects were exposed to both ADX-629 and placebo. Both ADX-629 and placebo were well tolerated, and no safety concerns were noted. Most assessments were statistically similar between treatment groups. In addition to statistical superiority of ADX-629 over placebo in Romberg test balance time, flushing, and acetaldehyde, levels of total cholesterol (P=0.02) and LDL (P=0.047) were statistically lower following ADX-629 treatment than following placebo treatment. The full results of the trial are expected to be presented at a medical meeting.\n\n“The...