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