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Phase 2 Trial of ADX-629 Underway for Treatment of AD

Article

ADX‑629 also is being evaluated in Phase 2 clinical trials for the treatment of chronic cough, idiopathic nephrotic syndrome, and Sjögren-Larsson Syndrome.

Aldeyra Therapeutics, Inc. has announced enrollment of the first patient in the phase 2 clinical trial of orally administered RASP modulator ADX‑629, an investigational new drug, for the treatment of atopic dermatitis.1



wladimir1804/AdobeStock

wladimir1804/AdobeStock

According to the biotechnology company, the multicenter, adaptive, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 alone and in combination with standard of care in adults with mild, moderate, or severe atopic dermatitis.

Approximately 10 patients will receive open-label ADX‑629 twice daily for 90 days in part 1 of the trial. Outcomes will include improvement in Investigator Global Assessment and Eczema Area and Severity Index scores. Top-line results from Part 1 are expected in the second half of 2023. Pending the results of Part 1, Part 2 will randomize patients to either ADX‑629 or placebo treatment twice daily for 90 days.

In patients with atopic dermatitis, the pro-inflammatory reactive aldehyde species (RASP) malondialdehyde is elevated compared to levels observed in healthy controls. By lowering RASP levels, ADX‑629 may diminish the inflammation associated with atopic dermatitis. ADX‑629 has previously demonstrated immune-modulating activity in clinical trials of patients with psoriasis, asthma, and COVID‑19.

Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, said in a press release, “ADX‑629, if approved, would be the first RASP modulator and one of the few orally administered therapies indicated for the treatment of atopic dermatitis.”

ADX‑629 is also currently being evaluated in phase 2 clinical trials for the treatment of chronic cough, idiopathic nephrotic syndrome, and Sjögren-Larsson Syndrome. Top-line results from the chronic cough trial are expected in the first 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.


Reference

1. Aldeyra Therapeutics Enrolls First Patient in Phase 2 Clinical Trial of ADX-629 in Atopic Dermatitis. Aldeyra. April 6, 2023. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-enrolls-first-patient-phase-2-clinical. Accessed April 10, 2023.

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