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Aldeyra Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of ADX‑2191 in Retinitis Pigmentosa
Top-Line Results Expected in the First Half of 2023 LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\nTop-Line Results Expected in the First Half of 2023\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the completion of enrollment in the Phase 2 clinical trial of ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of retinitis pigmentosa, a group of rare genetic eye diseases characterized by retinal cell death and loss of vision, for which there is no U.S. Food and Drug Administration (FDA)-approved treatment.\n\nThe open-label, single-center Phase 2 clinical trial enrolled a total of eight retinitis pigmentosa patients with rhodopsin gene mutations, including the P23H gene mutation. Patients receive either monthly or twice-monthly intravitreal doses of ADX‑2191 for three months. The primary endpoint of the trial is safety. Secondary endpoints include change from baseline in visual acuity; retinal function, as assessed by foveal microperimetry, electroretinography, and dark adaptation; and retinal morphology, as assessed by optical coherence tomography.\n\n“Given the lack of FDA-approved therapies for retinitis pigmentosa, a sight-threatening group of diseases that affect more than one million patients worldwide, novel therapeutic approaches are in demand,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Aldeyra is committed to working with patients and physicians to attempt to ameliorate the unrelenting burden of retinitis pigmentosa, and we look forward to reporting top-line results of the Phase 2 clinical trial in the first half of this year.”\n\nAbout ADX-2191\n\nADX-2191 is a novel intravitreal formulation of methotrexate, which in preclinical models of retinitis pigmentosa facilitates the clearance of misfolded rhodopsin, a critical visual cycle protein susceptible to genetic mutation.1 The prevalence of retinitis pigmentosa is more than one million people worldwide, and genetic mutations leading to rhodopsin misfolding account for approximately one-third of cases. ADX-2191 has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of retinitis pigmentosa.\n\nAbout Aldeyra\n\nAldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop pharmac...