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) Following Exposure to Alcohol
Aldeyra Plans to Support Investigator-Sponsored Phase 2 Clinical Trial of ADX-629 in Moderate Alcoholic Hepatitis, Expected to be Initiated in 2023
“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
ADX-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.
“The observed reduction in acetaldehyde, the key toxic RASP metabolite of ethanol, in addition to improvement in proprioception and reduction in flushing shown in this clinical trial, further support the potential of systemic RASP modulation as an innovative therapeutic approach across a variety of diseases characterized by inflammation,” stated
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 Sjögren-Larsson Syndrome are expected in 2023.
ADX-629, an investigational new drug, is a novel, orally administered RASP (reactive aldehyde species) modulator for the potential treatment of systemic immune-mediated diseases. RASP modulators potentially represent upstream immunological switches that shift immune systems from pro-inflammatory states to anti-inflammatory states. ADX-629 is a member of the same chemical class as reproxalap, an investigational new drug in late-stage development for dry eye disease and allergic conjunctivitis, two common ocular inflammatory diseases.
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