Aldeyra Therapeutics Enrolls First Patient in Phase 2 Clinical Trial of ADX-629 in Atopic Dermatitis

07 Apr 2023
pipelinereview.com
Phase 2Immunotherapy
Top-Line Results from Part 1 of the Trial Expected in the Second Half of 2023
LEXINGTON, MA, USA I April 06, 2023 IAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today 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.
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. In Part 1, approximately 10 patients will receive open-label ADX‑629 twice daily for 90 days. 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.
“Atopic dermatitis, a chronic hypersensitivity condition characterized by dry, itchy, and inflamed skin, affects an estimated 16.5 million adults and more than 9.6 million children in the United States,1” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “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.”
In patients with atopic dermatitis, the pro-inflammatory RASP malondialdehyde is elevated compared to levels observed in healthy controls.2,3 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.
In addition to atopic dermatitis, ADX‑629 also is 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. Top-line results from Part 1 of the idiopathic nephrotic syndrome and Sjögren-Larsson Syndrome trials 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.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop pharmaceuticals that modulate immunological systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX‑629, ADX‑246, ADX‑248, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated diseases. Our pre-commercial product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease (under U.S. Food and Drug Administration New Drug Application Review) and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of primary vitreoretinal lymphoma (under U.S. Food and Drug Administration New Drug Application Priority Review), proliferative vitreoretinopathy, and other rare sight-threatening retinal diseases. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.
1https://nationaleczema.org/research/eczema-facts.
2 Heliyon 28;7(3): e06621, 2021.
3 J Clin Diagn Res. 7(12): 2683-5, 2013.
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