Aldeyra Therapeutics Provides Clinical and Regulatory Update and Announces Advancement of RASP Platform in Systemic and Retinal Inflammatory Diseases

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced advancement of its RASP modulator platform, including the expected submission to the FDA of a proposed expansion of the Phase 2 clinical trial of the investigational RASP modulator ADX-629 in Sjögren-Larsson Syndrome to include pediatric patients, initiation of a Phase 2 clinical trial of ADX-629 in moderate alcoholic hepatitis, submission of an IND application of the investigational RASP modulator ADX-246 for a Phase 1 clinical trial that is expected to be expanded to include atopic dermatitis patients, anticipated submission of an IND application of the investigational RASP modulator ADX-248 for a Phase 1/2 clinical trial in patients with the dry form of age-related macular degeneration (AMD) and dark adaptation deficit, and initiation of a preclinical program of RASP modulators in metabolic disease.

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(Graphic: Aldeyra Therapeutics)

“With an unparalleled RASP modulator discovery and development platform, Aldeyra remains a leader in the development of RASP modulators for the treatment of immune-mediated disease,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.

Sjögren-Larsson Syndrome is a rare inborn error of metabolism due to mutations in fatty aldehyde dehydrogenase, leading to accumulation of fatty alcohols and fatty aldehydes. The disease is characterized clinically by cognitive delay, spasticity, and dermal compromise. There is no FDA-approved therapy for Sjögren-Larsson Syndrome. ADX-629, administered twice daily over 90 days, has completed initial clinical testing in three adult patients in an investigator-sponsored clinical trial. Broad-based normalization of the majority of abnormal metabolomic signatures was observed along with reduction in accumulation of fatty alcohols. A proposed expansion of the clinical trial to include pediatric patients is expected to be submitted to the FDA in the first half of 2024.