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 (P=0.001), and 24‑Hour Cough Count (P=0.001)
- ADX-629 Was Well Tolerated and No Safety Concerns Were Identified
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“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
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
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 Sjögren-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.
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