Artax Biopharma has announced the clinical validation of AX-158, a first-in-class oral Nck modulator, in a Phase 2a clinical trial for psoriasis. The trial, conducted across multiple centers in the UK, demonstrated statistically significant improvements in T cell and psoriasis-related biomarkers, alongside a favorable safety profile. These results highlight the potential of Nck modulation as a novel mechanism for treating autoimmune diseases.
The Phase 2a study involved 30 participants with mild to moderate plaque psoriasis, randomized 2:1 to receive either a 10mg daily dose of AX-158 or a placebo for 28 days, followed by a 30-day safety monitoring period. The primary objectives were to assess safety and confirm the mechanism of action of AX-158.
Safety and Tolerability
The Phase 2a study confirmed the well-tolerated safety profile observed in earlier Phase 1 studies. There were no reported infections, severe adverse events, or trial discontinuations. The few adverse events that did occur were mild to moderate and resolved without intervention.
Biomarker Analysis
An extensive psoriasis biomarker analysis, led by Dr. James Krueger at the Rockefeller University, revealed statistically significant and consistent effects of AX-158 on both disease and pathway-related genes. "For a novel mechanism of action, it is exciting to see how it can begin to impact disease processes, and I look forward to seeing how the response expands over a longer treatment period in future trials," said Dr. Krueger.
Clinical Implications and Future Directions
Rob Armstrong, CEO of Artax Biopharma, stated, "Today's results validate this truly orthogonal, novel mechanism of action in the autoimmune space. We were thoroughly delighted to see that Nck modulation was able to impact relevant biomarkers as well as clinical measurements, particularly in the moderate patient population. We were pleased to observe that PASI 75 responses also progressed in line with biomarker data in this study." The company plans to present the full results at an upcoming medical conference.
Given the broad effect of Nck modulation across various T helper cell populations, Artax Biopharma is planning further studies in other autoimmune diseases, including atopic dermatitis. Clinical results from these studies are anticipated by the end of 2026. Artax Biopharma believes there is significant potential for Nck modulation to revolutionize the treatment of T Cell-driven diseases by maintaining healthy control of the immune system without causing immunosuppression.
