Aldeyra Therapeutics has initiated Phase II clinical trials of a reactive aldehyde species (RASP) inhibitor, ADX-629, for treating Covid-19, atopic asthma and psoriasis.
These trials are part of a systematic strategy to analyse the orally administered treatment across various types of immunological diseases.
The Phase II trials come after successful Phase I clinical trial of ADX-629, which showed no treatment-related adverse events at tested doses and target engagement evidenced by statistically lower RASP levels in treatment group versus control arm.
Aldeyra Therapeutics president and CEO Todd Brady said: “The initiation of Phase II clinical testing of ADX-629, a first-in-class orally administered RASP inhibitor, is an exciting milestone for Aldeyra as we broaden the focus of our RASP platform from ocular indications to systemic disease.
“Unlike traditional immunologic drugs, ADX-629 is designed to modulate the immune system rather than shut down singular molecular targets, an approach that may lead to toxicity.”
The multicentre, double-blind, placebo-controlled, parallel-group Phase II 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.
For the asthma part, the single-centre, double-masked, placebo-controlled, crossover Phase II trial will evaluate the safety and efficacy of 600mg of ADX-629 in adult patients with mild asthma.
The multi-centre, open-label, single-group Phase 2 clinical trial for psoriasis will analyse the safety and efficacy of ADX-629.
The participants will be given 250mg of ADX-629 twice daily for up to 90 days.