Aldreya’s RASP Inhibitor ADX-629 enters phase 2 trial for COVID-19, asthma and psoriasis

December 27, 2020 0 By FM

The Lexington based biotech firm, Aldeyra Therapeutics has commenced phase II study of its reactive aldehyde species (RASP) inhibitor, ADX-629, for treating COVID-19, atopic asthma and psoriasis.

ADX-629 is a novel orally administered RASP inhibitor in phase 2 clinical development for the treatment of immune-mediated diseases. RASP inhibitors potentially represent upstream immunological switches that modulate immune systems from pro-inflammatory states to anti-inflammatory states.
The multicentre, double-blind, placebo-controlled, parallel-group trial in COVID-19 will anlayse the safety, tolerability, efficacy, and pharmacodynamics of 300mg of ADX-629 in adult patients. It will enrol around 30 participants who will receive the treatment or placebo twice daily for up to 28 days. Enrollment is expected to begin by year-end.

The single-centre, 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.

The multi-centre, 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.