AX-158 / Artax Biopharma - LARVOL DELTA

Artax Biopharma presents Phase 2a results for oral Nck modulator AX-158 in late-breaking session at the Society for Investigative Dermatology 2025 Annual Meeting (GlobeNewswire) - P2a | N=31 | NCT05725057 | Sponsor: Artax Biopharma Inc | "Key findings include: When administered every day at a 10mg dose, AX-158 was found to be safe and well-tolerated; No Grade ≥ 3 treatment-related adverse effects (TEAEs); No discontinuation due to TEAEs; No serious or opportunistic infections; Longitudinal skin biopsies showed a trend of reduction in the number of CD8+ T cells in patients treated with AX-158; Biomarker analyses revealed statistically significant impacts on IL-17 and IL-12 signalling pathways; Statistically significant modulation of multiple psoriasis-related gene sets was observed (MAD3, MAD5, Yao and Gudjonsson); At end of study, only patients who received AX-158 achieved PASI50 or greater."

Late-breaking abstract • P2a data • Psoriasis

Artax Biopharma to present Phase 2a data on Nck modulator AX-158, establishing novel mechanism of action in autoimmune disease at the 2025 SID Annual Meeting (GlobeNewswire) - "Artax Biopharma...announced that an abstract on the safety, efficacy and biomarker results of its Phase 2a study evaluating Nck modulator AX-158 in patients with psoriasis was accepted as a late breaking oral presentation at the Society for Investigative Dermatology (SID) Annual Meeting....Dr. Chris VanDeusen, Chief Scientific Officer, will present 'AX-158 Proof-of-Mechanism Safety Study: Evaluating a Novel T cell Receptor (TCR) Signal Modulator in Patients with Mild-to-Moderate Plaque Psoriasis (NCT05725057),' final abstract ID number LB1150, on May 9, 2025..."

Biomarker • Late-breaking abstract • P2a data • Psoriasis

Artax Biopharma Presents New Preclinical Data on Nck Modulators at 2025 AAD Annual Meeting (GlobeNewswire) - "Key findings include: Dose-dependent decrease in dust mite induced cytokine production from peripheral blood mononuclear cells (PBMCs) isolated from an atopic dermatitis patient; Treatment of healthy PBMCs with AX-158 resulted in a dose-dependent reduction in cytokine release across all T helper cell subtypes including IL-17, IL-4 and IL-13; Oral Nck modulator AX-194 significantly reduced ​the appearance of inflammation in an imiquimod model of dermal irritation, as demonstrated by reduction in the total number of hematopoietic cells and inflammatory macrophages in the skin....Based on this preclinical evidence, ​the Artax team is planning further studies in additional autoimmune diseases to explore the potential of Nck modulators to correct erroneous T cell activation in dermal autoimmune disorders."

Preclinical • Atopic Dermatitis

Artax Biopharma achieves clinical validation of first-in-class, oral, Nck modulator AX-158 for autoimmune disease in phase 2a study (PRNewswire) - P2a | N=31 | NCT05725057 | Sponsor: Artax Biopharma Inc | "The Phase 2a study confirmed the well-tolerated safety profile seen in the Phase 1 studies, with no infections reported and no severe adverse events. The few adverse events reported were mild or moderate in nature and resolved without intervention, and there were no trial discontinuations. An extensive psoriasis biomarker analysis was designed, conducted, and analyzed by Dr. James Krueger...His analysis demonstrates statistically significant and consistent effects on both disease and pathway-related genes in participants treated with AX-158...Given the broad effect of Nck modulation across all T helper cell populations (Th17, Th1/0 and Th2) in pre-clinical and animal models, the team is planning further studies in additional autoimmune diseases such as atopic dermatitis. Clinical results from these studies are anticipated by the end of 2026."

Clinical data • P2a data • Psoriasis

TCR-Nck Modulators: Pioneering Oral Modulation of T Cell Receptor Activation Holding the Promise of Treating Autoimmune Diseases (ACR Convergence 2024) - "These data suggest that selective TCR-Nck modulation represents a fundamental paradigm shift in the treatment of autoimmune diseases, one aligned with the restoration of self/non-self discrimination by the immune system."

CNS Disorders • Dermatology • Immunology • Multiple Sclerosis • Psoriasis • IL2

First-in-Human Evaluation of the Safety, Tolerability and Pharmacokinetics of the T Cell Receptor Signal Modulator AX-158 (ACR Convergence 2024) - P1/2 | "AX-158 was well tolerated at all oral dose levels. There were no safety concerns following SAD and MAD administration of AX-158 in healthy subjects, with no serious or treatment-related events, and no clinically significant findings. AX-158 demonstrated excellent bioavailability, with predictable PK outcomes supporting dosing independent of food effect."

Clinical • P1 data • PK/PD data • Dermatology • Immunology • Inflammation • Pain • Psoriasis

Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis (clinicaltrials.gov) - P1/2 | N=31 | Active, not recruiting | Sponsor: Artax Biopharma Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Artax Announces First Patient Dosed in Phase 2a Psoriasis Trial Evaluating AX-158 (PRNewswire) - P2a | N=30 | NCT05725057 | Sponsor: Artax Biopharma | "'The new Nck blocker class of agents, AX-158, has the potential to change how we treat autoimmune disease through targeting and tempering TCR responses so the body only, and properly, reacts against strong pathogens,' commented James G Krueger, MD, PhD...'I am excited to see how this new mechanism of action translates into biomarker changes and patient responses, where to date only targeted immunosuppression has been applied.'"

Media quote • Psoriasis

Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Artax Biopharma Inc | Not yet recruiting ➔ Recruiting | Phase classification: P2a ➔ P1/2

Enrollment open • Phase classification • Dermatology • Immunology • Psoriasis

Artax Granted Clinical Trial Authorization for AX-158 Phase 2a Psoriasis Study (PRNewswire) - "Artax Biopharma...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."

P2a data • Psoriasis

Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis (clinicaltrials.gov) - P2a | N=30 | Not yet recruiting | Sponsor: Artax Biopharma Inc | Trial completion date: Aug 2024 ➔ Dec 2024 | Initiation date: Aug 2023 ➔ Nov 2023 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Trial completion date • Trial initiation date • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Artax Biopharma Inc | Active, not recruiting ➔ Completed

Trial completion • Immunology

Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis (clinicaltrials.gov) - P2a | N=30 | Not yet recruiting | Sponsor: Artax Biopharma Inc | Initiation date: Apr 2023 ➔ Aug 2023

Trial initiation date • Dermatology • Immunology • Psoriasis

Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis (clinicaltrials.gov) - P2a | N=30 | Not yet recruiting | Sponsor: Artax Biopharma Inc

New P2a trial • Dermatology • Immunology • Psoriasis

A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Artax Biopharma Inc | Recruiting ➔ Active, not recruiting | N=104 ➔ 64 | Trial completion date: Aug 2022 ➔ Jan 2023 | Trial primary completion date: Aug 2022 ➔ Nov 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Immunology

Impacts of TCR-Nck Interaction Inhibitors on T Cell Activation Driven By Mixed Lymphocyte Reactions (TCT-ASTCT-CIBMTR 2022) - "Here we show that an oral, clinic-ready second generation Nck inhibitor (AX-158) potently modulates the activation of human T cells in Mixed Lymphocyte Reactions (MLR) in vitro, suggesting that disruption of the TCR-Nck interaction is modulatory for T cell responses driven by allogeneic stimuli...MLR driven proliferative responses were not significantly impacted, suggesting that Nck inhibition leads to less activated T Cell populations to drive potential benefit. By modulating T Cell activation in response to allogeneic stimuli while sparing responses to strong foreign antigens, Nck inhibitors offer the promise of potentially treating GVHD without strong immunosuppression."

Bone Marrow Transplantation • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Transplantation • IFNG • TNFA

A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Artax Biopharma Inc

New P1 trial • Immunology

Artax Biopharma Granted MHRA Clinical Trial Authorization for AX-158 (PRNewswire) - "Artax Biopharma, Inc...announced that the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted clinical trial authorization to evaluate AX-158 in a Phase 1 clinical trial for the treatment of T Cell-Mediated Diseases...The MHRA authorization marks the start of Artax's clinical trial program for its global platform of T Cell-mediated diseases. The AX-158 Phase 1 clinical trial is expected to start in the second half of this year....In preclinical studies, AX-158 decreased key cytokines including INFγ, TNFα and IL-2. Based on this activity, Artax is planning future clinical development in autoimmune diseases, T cell malignancies and other related T cell pathologies."

New P1 trial • Preclinical • Hematological Malignancies • Oncology