Artax Biopharma Announces Positive Phase 1 Results for AX-158, Company’s First-in-Class Oral Immunomodulator Developed to Treat T Cell-Mediated Diseases

Phase 1 Findings Demonstrated that Investigational Agent AX-158 Was Well Tolerated at All Doses, with a Profile that Strongly Supports Further Clinical Development Efforts

AX-158 is Being Developed for Once Daily Oral Dosing to Address Autoimmune Diseases by Providing Immunomodulation without Immunosuppression

Excerpt from the Press Release:

CAMBRIDGE, Mass., June 1, 2023 /PRNewswire/ — Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announces positive Phase 1 clinical trial results for AX-158, the Company’s first-in-class oral small molecule immunomodulator to enter clinical development to treat T Cell-mediated diseases.

The Phase 1 clinical trial findings demonstrated that AX-158:

• had no related adverse events in the clinical trial;
• was well tolerated at all doses, up to the maximum of 50mg QD in the single ascending dose cohorts and up to the maximum of 15mg QD for 10 days in the multiple ascending dose cohorts; and
• had a consistent, predictable pharmacokinetic (PK) profile and bioavailability among healthy volunteers, which supports the use of AX-158 as a once daily oral dosing regimen, which can be dosed independently of food.

Importantly, these positive results support the further evaluation of AX-158 at a once daily dose of 10mg in a Phase 2 clinical trial. AX-158 employs a first-in-class mechanism of action that selectively modulates T Cell responses that play a critical role in healthy immune system function. AX-158 has the potential to treat T Cell-mediated diseases through immunomodulation without the risk of immunosuppression.

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