Aldeyra 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.
"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."
The 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.
Additional 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.