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Aldeyra Therapeutics 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.
Source: aldeyra.com
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Aldeyra Therapeutics 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.
“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.”
COVID-19 – A Clinical Model of Cytokine Release Syndrome
The 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.
Atopic Asthma – A Clinical Model of Allergic Inflammation
The 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 include pulmonary function testing following allergen and methacholine challenge, sputum eosinophil counts, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first quarter of 2021.
Psoriasis – A Clinical Model of Autoimmune Disease
The multi-center, open-label, single-group Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild to moderate plaque psoriasis. Ten adult patients will receive 250 mg of ADX-629 twice daily for up to 90 days. Outcomes will include psoriasis area and severity index, skin cytokine transcription profiles, plasma leukocyte cytokine release following endotoxin-challenge, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first half of next year.
“We believe that ADX-629 has broad applicability to systemic immune-mediated diseases,” Dr. Brady said. “We look forward to characterizing more fully the immune modulating activity of ADX-629 in multiple types of severe inflammation.”
Source: aldeyra.com