Aldeyra Therapeutics, Inc. Announces Positive Top-Line Results from the Phase 2 Clinical Trial of Adx-629 in Patients with Chronic Cough
June 27, 2023 at 07:01 am EDT
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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.
Aldeyra Therapeutics, Inc. is a biotechnology company, which is engaged in discovering therapies designed to treat immune-mediated diseases. The Company's product candidates include reactive aldehyde species (RASP) modulators ADX-629, ADX-246, ADX-248, and chemically related molecules for the treatment of systemic and retinal immune-mediated diseases. Its pre-commercial product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the treatment of proliferative vitreoretinopathy and retinitis pigmentosa. Its ADX-629, is an orally administered RASP modulator in clinical development for atopic dermatitis, idiopathic nephrotic syndrome, moderate alcohol-associated hepatitis, chronic cough, and Sjogren-Larsson Syndrome. Its preclinical RASP platform includes ADX-246 and ADX-248 in development for metabolic, retinal diseases and systemic inflammatory diseases.