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Aldeyra Therapeutics Announces Next-Generation RASP-Modulator Drug Candidates Expected to Begin Clinical Trials for Systemic Immune-Mediated Diseases and Geographic Atrophy
ADX-246 for Systemic Immune-Mediated Diseases and ADX-248 for Geographic Atrophy Build on Aldeyra’s Drug Discovery and Development Engine Targeting RASP
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\nADX-246 for Systemic Immune-Mediated Diseases and ADX-248 for Geographic Atrophy Build on Aldeyra’s Drug Discovery and Development Engine Targeting RASP Modulation\n\nNew Product Candidates Highlight Aldeyra’s Clinical Indication Expansion to Systemic and Retinal Diseases Characterized by Inflammation\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the advancement of two investigational new drug candidates, ADX‑246 and ADX‑248, to clinical testing, pending completion of U.S. Food and Drug Administration Investigational New Drug (IND) requirements. ADX‑246 and ADX‑248 represent the most recent group of product candidates generated from Aldeyra’s systems-based drug discovery and development engine focused on novel RASP modulators designed to decrease immune responses that lead to disease. Pending completion of the IND requirements, a Phase 1 clinical trial of orally administered ADX‑246 for the treatment of systemic immune-mediated diseases, and a Phase 1/2 clinical trial of intravitreally injected ADX‑248 for the treatment of geographic atrophy, a sight-threatening retinal disease, are expected to initiate in the second half of 2023 or early 2024.\n\n“Highlighting Aldeyra’s expansion to treatment of diseases that affect the retina and other areas of the body, ADX-246 and ADX-248 further support Aldeyra’s position as a leader in RASP modulation, a novel pharmacology that potentially addresses a broad array of diseases characterized by inflammation,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Few safe, broadly active, orally administered therapeutic options are available for the treatment of systemic immune-mediated diseases, and only a single drug is approved for the treatment of geographic atrophy.”\n\nADX-246 is designed to treat immune-mediated systemic diseases thought to be caused or exacerbated by pro-inflammatory RASP. ADX-246 is one of the most potent RASP modulators developed by Aldeyra and has demonstrated activity following systemic administration in animal models of sepsis, hepatitis, and atopic dermatitis.\n\nADX-248 is designed to reduce the inflammation and macromolecular aggregate formation associated with geographic atrophy, a severe form of macular degeneration. Pro-inflammatory RASP are associated with infla...