Aldeyra to undertake phase 2 trial of ADX-629 in patients hospitalized with COVID-19
Aldeyra Therapeutics has received a “study may proceed” letter from the FDA for a phase 2 clinical trial evaluating ADX-629 as a treatment for adult patients hospitalized with COVID-19, according to a press release.
The company is also investigating a reactive aldehyde species (RASP) inhibitor as a biomarker for dry eye disease.
“What’s exciting about ADX-629 is its potential to act like a dimmer switch to modulate the aggressive immune response that is a hallmark of SARS-CoV-2, the virus that causes COVID-19,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, told Healio/OSN. “We’re still in the early innings in terms of clinical testing, but in animal models, ADX-629 has demonstrated a broad and highly statistically significant reduction in cytokine levels, which are critical mediators of inflammation in COVID-19. As a first-in-class, orally available inhibitor of RASP, ADX-629 has the potential to be clinically relevant not only for treating COVID-19 but also an array of inflammatory diseases that are not being adequately addressed by currently available therapies.”
The trial will enroll about 30 patients with COVID-19. Enrollment will occur upon hospitalization, and patients will be treated for up to 28 days with orally administered ADX-629 or placebo twice daily. The trial’s key endpoints will include the National Institute of Allergy and Infectious Diseases COVID-19 scale, in addition to levels of cytokines and RASP.
“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,” Brady said in the release.
ADX-629 is of the same chemical class as Aldeyra’s reproxalap, a RASP inhibitor in phase 3 clinical trials for dry eye disease and allergic conjunctivitis.