American biotech company Aldeyra Therapeutics said that it has enrolled the first patient in a phase 2 clinical trial of ADX‑629 for the treatment of atopic dermatitis.

ADX‑629 is an orally administered RASP modulator.

According to Aldeyra Therapeutics, the phase 2 trial will be held at multiple centers and will assess the efficacy and safety of ADX-629 alone or in combination with standard care. The mid-stage trial will feature adults suffering from mild, moderate, or severe atopic dermatitis.

In part 1, about 10 patients will receive ADX-629 two times a day over 90 days. Results will include improvement of investigator global assessment and Eczema Area and Severity Index scores.

The top-line results of part 1 are likely to be out in the latter half of this year. Based on the outcomes of part 1, part 2 of the atopic dermatitis clinical trial will randomly assign patients to either ADX-629 or placebo every day twice for 90 days.

For atopic skin dermatitis patients, the pro-inflammatory RASP malondialdehyde levels are higher in comparison to the levels seen in healthy controls. Through the decrease in RASP amounts, ADX-629 could lessen the inflammation caused by atopic dermatitis.

Previously, ADX-629 showed the ability to modulate immune systems in clinical trials for asthmatic patients, patients with psoriasis, as well as Covid-19.

Todd C. Brady — Aldeyra Therapeutics President and CEO said: “Atopic dermatitis, a chronic hypersensitivity condition characterized by dry, itchy, and inflamed skin, affects an estimated 16.5 million adults and more than 9.6 million children in the United States.

“ADX‑629, if approved, would be the first RASP modulator and one of the few orally administered therapies indicated for the treatment of atopic dermatitis.”

Apart from Atopic dermatitis, ADX-629 is being tested as part of phase 2 clinical trials to help with the treatment of chronic cough, Sjogren-Larsson Syndrome, and idiopathic renal syndrome.

The top-line results of the chronic cough study are predicted during the first half of this year, while the top-line outcomes from part 1 of the idiopathic renal syndrome trial and the Sjogren-Larsson syndrome trials are anticipated in the latter half of 2023.

A phase 2 clinical trial of ADX-629 in moderate alcohol-related hepatitis is anticipated to start in the second half of this year, said Aldeyra Therapeutics.

  ADX‑629, Aldeyra Therapeutics, Atopic dermatitis, Todd C. Brady, USA