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Aldeyra Receives Study May Proceed Letter from FDA to Initiate Clinical Trial of ADX-629 in COVID-19 Patients
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that it has received a Study May Proceed letter from
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":" LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial evaluating ADX-629, a novel orally available reactive aldehyde species (RASP) inhibitor, for the treatment of adult patients hospitalized for COVID-19.\n\n\n“The FDA’s clearance of our Investigational New Drug application for Phase 2 testing in patients with COVID-19 is an important milestone for ADX-629, which represents a new paradigm in the treatment of immune-mediated diseases,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “The COVID-19 clinical trial is part of a broad systemic disease strategy designed to demonstrate ADX-629 proof of concept in serious inflammatory diseases with critical medical need.”\n\n\nThe planned Phase 2 clinical trial is expected to enroll approximately 30 patients with COVID-19. Patients will be enrolled upon hospitalization for COVID-19 and treated with orally administered ADX-629 or placebo twice-daily for up to 28 days. Key endpoints will include the National Institute of Allergy and Infectious Diseases COVID-19 scale and levels of cytokines and RASP.\n\n\nAdditional proof of concept Phase 2a clinical trials of ADX-629 in psoriasis and atopic asthma are expected to initiate in the fourth quarter of 2020. The timing of trial initiations depends, in part, on restrictions related to COVID-19, the availability of clinical research facilities and staffing, the ability to recruit patients, and regulatory feedback.\n\n\nAbout ADX-629\n\n\nADX-629 is a novel orally administered RASP inhibitor in Phase 2 clinical development for the treatment of immune-mediated diseases. RASP inhibitors have the potential to represent upstream immunological switches that modulate immune systems from pro-inflammatory states to anti-inflammatory states. ADX-629 is a member of the same chemical class as reproxalap, a RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, two common ocular inflammatory diseases.\n\n\nAbout Aldeyra Therapeutics\n\n\nAldeyra Therapeutics is 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. ...