Artax Biopharma completes patient recruitment in Phase 2a trial with first-in-class Nck modulator AX-158

AX-158 has broad potential to treat many autoimmune diseases without causing immunosuppression 

Psoriasis biomarker panel and PASI scores expected later this year

CAMBRIDGE, Mass., Aug. 13, 2024 /PRNewswire/ -- Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, today announces the completion of patient recruitment for its Phase 2a clinical trial with AX-158, a first-in-class Nck modulator for autoimmune diseases.

"We are thrilled to have completed patient recruitment for this trial and wish to thank all participating patients and healthcare professionals for their willingness to help us evaluate the potential of this novel Nck modulator mechanism for autoimmune diseases," said Dr. Scott Batty, Chief Medical Officer of Artax Biopharma. "The data will include the safety and tolerability of AX-158 in psoriasis patients and clinical assessments, such as PASI¹ and DLQI². However, we are most eager to see the changes in a wide panel of disease-relevant biomarkers, which will help contextualize the impact and cadence of the response to treating via this orthogonal approach to current autoimmune therapies."

"Investigating the impact of this novel mechanism of action on the disease related biomarkers will contribute to the body of knowledge in this field, and I am intrigued to see what this data will show," commented James G. Krueger, M.D., Ph.D., Head of the Laboratory for Investigative Dermatology at The Rockefeller University and Artax Scientific Advisory Board member. "If Nck modulation delivers on the pre-clinical promise, then this may unlock a new treatment paradigm, which is broadly applicable across autoimmune diseases."

Artax expects to announce the results from this first patient trial before the end of 2024.

About the Phase 2a trial with AX-158 in psoriasis

AX-158 is being evaluated in a Phase 2a Proof-of-Mechanism study in patients with mild to moderate plaque psoriasis in multiple centers in the UK. Participants were randomized 2:1 to receive a single dose AX-158 or a placebo. A total of 30 participants are being treated for 28 days and will be followed for an additional 30 days for safety. We anticipate reporting topline results in Q4 2024.

About Artax Biopharma, Nck modulation, and AX-158
Artax Biopharma is a clinical-stage biotechnology company transforming the treatment of T Cell-driven autoimmune diseases. Artax's first-in-class oral small molecules aim to deliver immune system modulation without immunosuppression, potentially unlocking new treatment options as both monotherapy and in combination with other treatments. Lead program AX-158 will deliver Phase 2a Proof of Concept data in psoriasis later in 2024.

We believe there is significant potential for Nck modulation to revolutionize treatment of T Cell-driven diseases. 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. 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.

AX-158, our lead Nck modulator, has shown strong, broad cytokine modulation as well as modulation of mixed lymphocyte reactions. Good data on therapeutic efficacy with AX-158 were observed in murine models of self-antigen activation (EAE), with a prolonged pharmacodynamic effect in EAE, suggesting durable immune modulation. AX-158 showed no immunosuppression in models of strong antigen stimulation. Studies with AX-158 showed substantial preclinical evidence of activity in the Th₂, Th₁₇, Th₁/Th₀ pathways, suggesting that applications could be quite broad across the autoimmune space.

Artax Biopharma is based in the Boston area and raised Series A & B from Advent Life Sciences, Sound Bioventures, and Columbus Venture Partners. For more info, see www.artaxbiopharma.com or follow us on LinkedIn. 

For future clinical study inquiries: [email protected]

Contacts:
Maria Nichol, DPhil, EPA, CPA
Chief Business Officer
[email protected] 

Media:
Linda Phelan Dyson, MPH
Corporate Communications
+1 973-986-5873
[email protected]

¹ PASI = Psoriasis Area Severity Index
² DLQI = Dermatology Life Quality Index

SOURCE Artax Biopharma