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Aldeyra Therapeutics Announces Initiation of Phase 2 Clinical Trials of ADX-629, a First-in-Class Orally Administered RASP Inhibitor, for the Treatment of COVID-19, Atopic Asthma, and Psoriasis
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials of ADX-629,
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":" LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials of ADX-629, a first-in-class orally administered reactive aldehyde species (RASP) inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis as part of a systematic strategy to assess activity across different types of immunological diseases. The Phase 2 clinical trials follow a successful Phase 1 clinical trial of ADX-629, which demonstrated no treatment-related adverse events at any dose tested, as well as target engagement evidenced by statistically lower RASP levels in drug-treated subjects relative to controls.\n\n“The initiation of Phase 2 clinical testing of ADX-629, a first-in-class orally administered RASP inhibitor, is an exciting milestone for Aldeyra as we broaden the focus of our RASP platform from ocular indications to systemic disease,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “The Phase 2 clinical trials announced today underscore our mission to develop new therapies that improve patient outcomes by fine-tuning the body’s immune response. Unlike traditional immunologic drugs, ADX-629 is designed to modulate the immune system rather than shut down singular molecular targets, an approach that may lead to toxicity.”\n\nCOVID-19 – A Clinical Model of Cytokine Release Syndrome \n\nThe multi-center, double-blind, placebo-controlled, parallel-group Phase 2 clinical trial in COVID-19 will evaluate the safety, tolerability, efficacy, and pharmacodynamics of ADX-629 in adult patients. Approximately 30 patients will be randomized to receive either 300 mg of 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 plasma levels of cytokines and RASP. Enrollment is expected to begin by year-end.\n\nAtopic Asthma – A Clinical Model of Allergic Inflammation \n\nThe single-center, double-masked, placebo-controlled, crossover Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild asthma induced by bronchial asthma challenge. Twelve patients with cat or house dust mite allergen-induced asthma will be randomized to receive either 600 mg of ADX-629 or placebo twice daily for approximately one week. Outcomes will in...