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Aldeyra Announces Positive Top-Line Phase 1 Clinical Trial Results and Clinical Development Plans for ADX-629
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":" LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced positive top-line Phase 1 clinical trial results for ADX-629, a first-in-class orally available reactive aldehyde species (RASP) inhibitor in development for the treatment of systemic immune-mediated diseases. Aldeyra also announced Phase 2 clinical development plans for ADX-629.\n\n\nThe Phase 1 clinical trial was a single-ascending and multiple-ascending dose trial to assess the pharmacokinetic, pharmacodynamic, safety, and tolerability profile of ADX-629 administered orally to healthy volunteers. Of the 85 subjects enrolled in the trial, 41 received ADX-629 orally as a single dose; 23 received ADX-629 orally twice per day for 10 days; and 21 received placebo. ADX-629 was well-tolerated, and no treatment-related adverse events were observed in the trial. No clinically meaningful changes were observed in vital signs, quantitative electrocardiography, or blood chemistry results. Clinically relevant plasma concentrations exceeding known levels of RASP were observed. Relative to subjects treated with placebo, reduction in the commonly described pro-inflammatory RASP malondialdehyde was observed in treated subjects.\n\n\n“To our knowledge, ADX-629 is the first orally available and irreversible covalent inhibitor of pro-inflammatory RASP, and potentially represents a new paradigm in the understanding and treatment of immune-mediated disease,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “The results from the Phase 1 clinical trial announced today support the potential to test ADX-629 broadly across serious diseases characterized by severe inflammation not well-addressed by current therapy.”\n\n\nUnlike most currently available drugs, the RASP targets of ADX-629 are small molecules rather than proteins. As such, ADX-629 could represent a new pharmacotherapeutic approach with potential applications across a large number of immune-mediated diseases. RASP are upstream mediators of inflammation, regulating known mediators such as NF-κB, inflammasomes, and scavenger receptor A. ADX-629 covalently binds RASP, which are then degraded intracellularly. ...