Aldeyra Therapeutics Highlights Recent Preclinical Data in Obesity, Atopic Dermatitis, Pain, and Alcoholic Hepatitis, and Announces Planned Pivotal Clinical Trial in Retinitis Pigmentosa, at 2024 Research & Development Day

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) will host the Aldeyra 2024 Research & Development Day with investors and financial analysts in New York City to present recent pipeline developments relating to the RASP modulation platform and ADX-2191 for the treatment of retinitis pigmentosa.

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(Graphic: Aldeyra Therapeutics)

Aldeyra will present new preclinical data from investigational RASP modulators in animal models for obesity, atopic dermatitis, inflammatory pain, and alcoholic hepatitis. In the diet-induced model of obesity, ADX-629 decreased weight and fat mass alone and in combination with a GLP-1 agonist. In the oxazolone model of atopic dermatitis, RASP modulators ADX-629, ADX-246, and ADX-248 demonstrated activity in reducing skin thickness and erosion, and in reducing spleen to body weight ratio. In the carrageenan model of inflammatory pain, ADX-246 increased tolerance to mechanical and thermal pain, and decreased joint swelling. Consistent with previously released data from ADX-629 in a model of alcoholic hepatitis, ADX-246 reduced levels of fibrosis and fat in liver.

“The new data released today support the expansion of our novel RASP platform into clinical indications that may include fat-mass-targeted weight loss and inflammatory pain, highlighting the breadth of potential product candidate opportunities afforded by modulating RASP levels,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.

Based on recent discussions with the U.S. Food and Drug Administration (the FDA), Aldeyra intends to initiate a potentially pivotal Phase 2/3 clinical trial of investigational product candidate ADX-2191 (methotrexate injection, USP) in patients with retinitis pigmentosa due to rhodopsin misfolding mutations. The potential activity of ADX-2191 in retinitis pigmentosa is supported by results from a Phase 2 clinical trial, announced in 2023, which demonstrated improvements from baseline in retinal sensitivity following treatment. An overview of the unmet medical need in retinitis pigmentosa will be provided by Ramiro Maldonado, M.D., Principal Investigator of the Phase 2 clinical trial and Assistant Professor of Ophthalmology, Vitreoretinal Diseases, and Surgery at Duke University.