Aldeyra Therapeutics, Inc. announced positive top-line results from the Phase 2 clinical trial of ADX-629 in patients with chronic cough. The multicenter, randomized, double-blind, placebo-controlled, two-period Phase 2 crossover trial enrolled 51 patients with refractory or unexplained chronic cough, which is often defined as a cough that persists for more than eight weeks and is unresponsive to treatment. Patients were randomized to receive ADX-629 or placebo twice daily for 14 days, followed by a 14-day washout period prior to crossing over to 14 days of treatment with ADX 629 or placebo, whichever was not received in the first period. The primary endpoint of the clinical trial was safety. Secondary endpoints included awake cough frequency (the key secondary endpoint), 24-hour cough frequency, quality of life, and clinical impression scales. Fifty-one patients were enrolled, and all patients completed both treatment periods. Relative to placebo, statistical significance was achieved for the key secondary endpoint of reduction in awake cough frequency (P=0.01), the secondary endpoint of 24-hour cough frequency (P=0.001), and the related post-hoc analyses of awake cough count (P=0.001) and 24-hour cough count (P=0.001). Quality of life and clinical impression scales did not consistently change between treatment groups over the two-week treatment periods. ADX 629 was well tolerated, and no safety concerns were identified following administration of either ADX 629 or placebo. No serious adverse events were reported, adverse event frequencies were similar across treatment groups, and no patients discontinued due to adverse events. Frequent coughing, which is characteristic of a number of inflammatory pulmonary diseases, represents a persistently disturbing condition for patients," stated Gary N. Gross, MD., Clinical Professor of Internal Medicine at Southwestern Medical School and a Board-certified allergist and immunologist with the Dallas Allergy
& Asthma Center. The difficulty in treating chronic coughing highlights the medical need for new therapies." Consistent with a Phase 1 clinical trial and the Phase 2 clinical trial in psoriasis, improvement in LDL and HDL
levels was observed following treatment with ADX 629 relative to treatment with placebo. 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. ADX 629 is also currently in development for atopic dermatitis, idiopathic nephrotic syndrome, and Sj gren-Larsson Syndrome. Initial results from each trial are
expected in the second half of 2023. A Phase 2 clinical trial of ADX 629 in moderate alcohol-associated hepatitis is expected to initiate in the second half of 2023.