Artax Granted Clinical Trial Authorization for AX-158 Phase 2a Psoriasis Study

Patient Enrollment Expected to Begin by Year End

Phase 2a Study Seeks to Demonstrate the Safety and Efficacy of AX-158 in Patients with Mild-to-Moderate Psoriasis, Further Advancing a New Approach to Address Autoimmune Diseases

Globally Nearly 125 Million People Live with Psoriasis

CAMBRIDGE, Mass., Nov. 9, 2023 /PRNewswire/ -- Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announces that the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted clinical trial authorization (CTA) to evaluate AX-158 in a Phase 2a psoriasis study.

This authorization marks the initiation of the clinical trial process, allowing initial patient enrollment by the end of 2023.  The clinical trial sites are located throughout the United Kingdom.

The study, A Phase 2a, Proof of Concept Study Evaluating the Safety and Tolerability of AX-158 in Patients With Mild to Moderate Plaque Psoriasis (NCT-05725057) will evaluate the safety and efficacy of AX-158 versus placebo.

"We are proud to announce the clinical progress of AX-158 and the potential that it may provide a novel treatment to patients managing psoriasis," stated Artax Biopharma Chief Executive Officer Joseph Lobacki. "Additionally, we are excited by the promise of AX-158 as a new standard of care in treating a broad range of autoimmune diseases.  In particular, we believe that AX-158 will offer the opportunity to provide a convenient once daily oral therapy that will treat disease while not impairing the ability of the patient's immune system to function properly."

Prof. Menno de Rie, MD, Department of Dermatology, Amsterdam UMC, The Netherlands, and an Artax Scientific Advisory Board member, commented: "As a physician and as a researcher treating psoriasis for decades, I can attest to the dire need for safe, effective, and tolerable therapies that will truly help patients manage their disease. I am excited about the innovation and tremendous science AX-158 represents for the many people with psoriasis. Managing autoimmune disease without inducing the profound immunosuppression associated with current conventional or biological therapies will be transformative for the immunology field."

About AX-158
Immunomodulation assists the immune system in maintaining healthy control and addresses the underlying driver of T Cell-mediated diseases. AX-158 is an investigational oral, small molecule immunomodulator with a novel first-in-class mechanism that selectively modulates, or adjusts, T cell responses which play a critical role in healthy immune system function. By acting at the T Cell Receptor (TCR), AX-158 modulates multiple disease-causing cytokines without immunosuppression. It can be taken with or without food, and may be used as a monotherapy, or in combination.

About Psoriasis
Psoriasis is a common, immune-mediated disease that affects 125 million people globally.  In the US 3.0% of the adult population, or more than 7.5 million adults, are affected.  Psoriasis patients may exhibit visible signs of inflammation anywhere on the body as raised plaques and scales on the skin. Plaques may appear as few small patches or can affect large areas. It is possible to have psoriasis plaques and scales on more than one location on the body at a time.  Treating psoriasis can help improve symptoms as well as lower the risk of developing other health conditions such as psoriatic arthritis, heart disease, obesity, diabetes, and depression.

About Artax Biopharma and Immunomodulation
Artax Biopharma is a clinical-stage biotechnology company transforming the treatment of T Cell-driven autoimmune diseases through innovative small molecules delivering immune system modulation without immunosuppression. Immunomodulation maintains healthy control of the immune system and addresses the underlying source of T Cell-driven diseases. Central to a well-functioning immune system is the T Cell Receptor (TCR).  When TCR signaling becomes dysregulated, it causes T Cell-driven conditions, including autoimmune diseases, and induced T Cell pathologies where medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host-disease or immuno-oncology treatments resulting in immune related-adverse events). We believe the immunomodulation mechanism offered by our investigational agents holds broad potential to revolutionize how these T Cell-driven autoimmune diseases are addressed, while not impairing the ability of a patient's immune system to function properly. artaxbiopharma.com

For Phase 2a study inquiries, please contact: [email protected]

SOURCE Artax Biopharma