Aldeyra Therapeutics announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, an investigational oral RASP modulator, for the treatment of several systemic diseases, including atopic dermatitis.

For the atopic dermatitis indication, the multicenter, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 over 12 weeks of treatment. Part 1 of the trial is expected to enroll approximately 10 patients. Pending the results of Part 1, Part 2 will compare ADX-629 to placebo. Outcomes will include improvement in Investigator Global Assessment and Eczema Area and Severity Index scores. Topline results from Part 1 of the clinical trial are expected in 2023.

ADX‑629 is also being evaluated for the treatment of minimal change disease and Sjögren-Larsson Syndrome. Aldeyra also announced the expansion of the minimal change disease clinical trial to encompass idiopathic nephrotic syndrome, a broad group of rare immune-mediated kidney disorders that includes minimal change disease.

“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,” Todd C. Brady, MD, PhD, President and Chief Executive Officer of Aldeyra, said in a company news release. “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.