Aldeyra Therapeutics has commenced Phase II clinical trials of its new investigational oral RASP modulator, ADX‑629, to treat minimal change disease and Sjögren-Larsson Syndrome.
The Phase II clinical trials are designed to assess the efficacy and safety of ADX‑629.
The oral RASP modulator has been developed to potentially treat systemic and retinal immune-mediated diseases.
Aldeyra has also announced the expansion of the Phase II clinical trial in minimal change disease to include idiopathic nephrotic syndrome, which is a wide group of rare kidney disorders.
The multicentre, two‑part, adaptive Phase II clinical trial will assess the efficacy and safety of ADX‑629 and a placebo over 12 weeks of treatment in adults and children.
Part 1 of the trial is anticipated to enrol five patients, with top-line results expected this year.
Frequency of relapse that is defined by corticosteroid therapy requirement will be one of the trial’s outcomes.
Aldeyra has also announced the start of a Phase II clinical trial of ADX‑629 for the treatment of atopic dermatitis, a chronic hypersensitivity condition.
The two-part, adaptive, multicentre Phase II clinical trial is designed for assessing ADX‑629’s efficacy and safety over 12 weeks of treatment.
In Part 1, nearly ten participants are expected to be enrolled, with top-line results expected this year.
The second part of the trial will compare ADX-629 against a placebo.
Improvement in Investigator Global Assessment and Eczema Area and Severity Index scores will be some of the outcomes of the trial.
Aldeyra CEO and president Todd Brady said: “Following the completion of successful proof-of-concept trials in psoriasis, asthma, Covid-19, and alcohol toxicity, the ADX‑629 trials announced today further advance the promising novel pharmacology of our proprietary RASP modulator platform for the treatment of systemic diseases.
“ADX-629 has the potential to become a first-in-class therapy that may allow for convenient, non-injected, orally administered, broad-based treatment of immune-mediated diseases.”
Currently, ADX-629 is being assessed in a placebo-controlled, randomised, two-period multicentre, double-blind Phase II crossover trial in nearly 50 refractory or unexplained chronic cough patients.