Business
Aldeyra Therapeutics Announces Statistically Significant Reduction in Cough Frequency in Phase 2 Clinical Trial of ADX‑629 in Patients With Chronic Cough
Relative to Placebo, Statistical Significance Achieved for Reduction in Awake Cough Frequency (P=0.01), 24‑Hour Cough Frequency (P=0.001), Awake Cough Count
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nRelative to Placebo, Statistical Significance Achieved for Reduction in Awake Cough Frequency (P=0.01), 24‑Hour Cough Frequency (P=0.001), Awake Cough Count (P=0.001), and 24‑Hour Cough Count (P=0.001)\n\n\n\nADX-629 Was Well Tolerated and No Safety Concerns Were Identified\n\n\n\nCompany to Discuss Results in Conference Call and Webcast at 8:00 a.m. ET Today\n\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced positive top-line results from the Phase 2 clinical trial of orally administered ADX‑629, an investigational new drug, in patients with chronic cough. The clinical trial demonstrated statistically significant reduction in cough frequency following administration of ADX‑629 relative to placebo.\n\n\n“Consistent with previously demonstrated activity in clinical trials of patients with psoriasis, asthma, and COVID-19, the reduction in cough frequency observed in the Phase 2 clinical trial in chronic cough supports the potentially broad-based activity of ADX‑629 as a novel, immune-modulating therapeutic approach,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “We look forward to discussing the results with regulatory authorities as we consider the expansion of clinical testing to include patients with co-morbid conditions of frequent coughing and active inflammation.”\n\n\nThe 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.\n\n\nFifty-one patients were enrolled, and all patients completed both treatment periods. Relative to placebo, statistical significance was ach...