Aldeyra Therapeutics' Chronic Cough Potential Shows Significant Reduction In Cough Frequency Versus Placebo

Aldeyra Therapeutics Inc ALDX announced top-line results from the Phase 2 clinical trial of ADX‑629, an investigational new drug administered orally to patients with chronic cough.

The company plans to discuss these results with regulatory authorities while considering expanding clinical testing to include patients with frequent coughing and active inflammation.

The Phase 2 trial included 51 patients suffering from refractory or unexplained chronic cough that persists for more than eight weeks and is unresponsive to treatment.

The trial's primary endpoint was safety. Secondary endpoints included awake cough frequency, 24-hour cough frequency, quality of life, and clinical impression scales.

The trial achieved statistical significance for the key secondary endpoint of reduction in awake cough frequency, the secondary endpoint of 24-hour cough frequency, and related post-hoc analyses of awake and 24-hour cough count.

ADX‑629 was well-tolerated, with no safety concerns identified following administration.

ADX‑629 is an orally administered RASP (reactive aldehyde species) modulator under investigation to potentially treat systemic immune-mediated diseases. It's also under development for atopic dermatitis, idiopathic nephrotic syndrome, and Sjögren-Larsson Syndrome.

Initial results from each trial are anticipated in 2H of 2023. A Phase 2 trial of ADX‑629 in moderate alcohol-associated hepatitis is expected to start in 2H of 2023.

Last week, Aldeyra received a Complete Response Letter from the FDA for the 505(b)(2) New Drug Application of ADX-2191 (methotrexate for injection) for primary vitreoretinal lymphoma. 

Price Action: ALDX shares are up 2.66% at $7.71 on the last check Tuesday.