Aldeyra Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of ADX-629 in Chronic Cough

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the completion of enrollment in the Phase 2 clinical trial of the orally administered RASP modulator ADX-629, an investigational new drug, for the treatment of chronic cough.

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In a preliminary study, RASP were observed to be elevated in the bronchioalveolar lavage fluid of patients with chronic cough. (Graphic: Aldeyra Therapeutics, Inc.)

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.¹ 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 trial is safety. Secondary endpoints include awake cough frequency, 24-hour cough frequency, patient-reported cough severity, quality of life, and patient and clinician global impression of change. Top-line results are expected in the first half of 2023.

“Chronic cough is a debilitating disease with dysregulated immunological and neurosensory components that impair quality of life,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Given the lack of FDA-approved therapy, the unmet need for treatment is significant.”

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. In a preliminary study, RASP were observed to be elevated in the bronchioalveolar lavage fluid of patients with chronic cough,² and may contribute to neurosensory dysfunction as well as inflammation. By lowering RASP levels, ADX-629 potentially represents a novel therapeutic approach with two distinct mechanisms of action. ADX-629 has previously demonstrated activity in clinical trials of patients with psoriasis, asthma, COVID-19, and alcohol toxicity.