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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.