Aldeyra Receives Study May Proceed Letter from FDA to Initiate Clinical Trial of ADX-629 in COVID-19 Patients

LEXINGTON, Mass.--Sep. 9, 2020-- Aldeyra Therapeutics, Inc. 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.

About ADX-629

ADX-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.

About Aldeyra Therapeutics

Aldeyra 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. Two of the company’s lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP) which are elevated in ocular and systemic inflammatory disease, and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis, and ADX-629 is in Phase 2 clinical development for the treatment of systemic inflammatory diseases. The company’s clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer.

David McMullin
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218

Investor & Media:
Scott Solomon
Sharon Merrill Associates, Inc.
Tel: 617-542-5300

Source: Aldeyra Therapeutics, Inc.

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