Clinical Validation Reached in Phase 2a Trial of AX-158 for Psoriasis

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Artax announced today that clinical validation was reached in a phase 2a trial of AX-158, a fully proprietary oral agent for the treatment of psoriasis.¹ These results confirm both preclinical data and phase 1 findings. The first patient was dosed with this novel mechanism for mild to moderate plaque psoriasis in February 2024.²

"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,” CEO Rob Armstrong, said in a statement.¹

The randomized, double-blind, placebo-controlled study took place in multiple centers across the UK. A total of 30 participants received a single daily dose of either 10mg AX-158 or placebo. The trial lasted 28 days, followed by an additional 30-day safety period upon the conclusion of treatment.

AX-158 had a well-tolerated safety profile with no severe adverse effects or infections, just like in phase 1. Any mild or moderate adverse effects resolved quickly and without intervention. None of the patients discontinued use.

The investigational oral, small molecule immunomodulator selectively modulates T cell responses and acts as a T cell receptor, making it a novel breakthrough in psoriasis treatment. It has the capability to be used as monotherapy or in combination with another therapy.

Dr. James Krueger, Head of Laboratory for Investigative Dermatology at The Rockefeller University and member of the Scientific Advisory Board at Artax, conducted an extensive psoriasis biomarker analysis. In the patients treated with AX-158, he found statistically significant effects on disease and pathway-related genes in line with PASI improvements.

"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,” Kreuger said in a press release.¹

Artax will report these results at an upcoming conference. The company is also planning to extend this Nck modulation into future studies on other autoimmune diseases such as atopic dermatitis.

“We would like to thank the investigative clinicians, their teams, and all participating patients for their valuable contribution to advancing this science. There is so much work left to do in the autoimmune space,” Armstrong added. “With AX-158 and our portfolio of Nck modulators, we see great potential to address the treatment gap for patients."¹

References

1. Artax Biopharma achieves clinical validation of first-in-class, oral, Nck modulator AX-158 for autoimmune disease in phase 2a study. PR Newswire. January 22, 2025. Accessed January 22, 2025. https://www.prnewswire.com/news-releases/artax-biopharma-achieves-clinical-validation-of-first-in-class-oral-nck-modulator-ax-158-for-autoimmune-disease-in-phase-2a-study-302356945.html

2. Artax announces first patient dosed in phase 2a psoriasis trial evaluating AX-158. News release. PR Newswire. February 13, 2024. Accessed January 22, 2025. https://www.prnewswire.com/news-releases/artax-announces-first-patient-dosed-in-phase-2a-psoriasis-trial-evaluating-ax-158-302060157.html