• The first subjects have been successfully dosed with AX-202 at The Medicines Evaluation Unit in Manchester UK
  • In this phase 1 trial, Arxx Therapeutic’s monoclonal antibody AX-202 is being tested in healthy volunteers and patients with psoriasis, leading into Arxx’s program in systemic sclerosis

OSLO, Norway I May 08, 2023 I Arxx Therapeutics, a Norwegian-Danish biotech company developing innovative therapies for fibrotic diseases, today announces that the first cohort of healthy volunteers have successfully been dosed with AX-202 – a first-in-class anti-S100A4 monoclonal antibody (mAb). The trial is led by Professor David Singh at the Medicines Evaluation Unit in Manchester, UK.

The double-blind, placebo-controlled trial aims to establish the safety and tolerability of AX-202 and is expected to enroll a total of 40 healthy volunteers and 18 patients with mild to moderate psoriasis. Trial results are expected in 2024, aiming to support the initiation of a clinical program in patients with systemic sclerosis.

Systemic sclerosis is a rare, life-threatening disease characterized by progressive fibrosis involving the skin and internal organs. Current treatment options are limited and new disease-modifying therapies are needed to improve and extend the lives of systemic sclerosis patients.

AX-202 is a first-in-class mAb targeting the upstream alarm signal S100A4, which plays a dual role in driving both inflammation and fibrosis. Preclinical studies have demonstrated the ability of AX-202 to prevent and treat fibrosis and modify the disease-specific activation of fibroblasts – the key effector cells driving progression of fibrosis. Arxx aims to develop AX-202 as a disease-modifying agent for systemic sclerosis and other rare fibrotic diseases.

Prof Dr Oliver Distler, Director Department of Rheumatology at Universitätsspital Zürich said: “New treatment options for systemic sclerosis are urgently needed. AX-202 represents a unique and scientifically compelling new therapeutic approach for systemic sclerosis supported by a very comprehensive preclinical data package.”

Dr Jonas Hallén, Chief Medical Officer of Arxx Therapeutics added: “The initiation of this trial is a major milestone for Arxx Therapeutics. We are excited about the potential of AX-202 to help patients suffering from systemic sclerosis and other fibrotic diseases. AX-202 has a unique and differentiated mechanism-of-action that we believe holds great promise as a true disease-modifying therapy.”

About Arxx Therapeutics

Arxx Therapeutics is a Scandinavian biotechnology company founded by scientists and drug developers dedicated to help the large number of patients whose lives are impacted by fibrotic disease. Arxx is leveraging more than 30 years of research by its scientific co-founders uncovering the pathobiology of S100A4; a Damage Associated Molecular Pattern protein upregulated upon stress or injury allowing cells to sense and react to danger. In chronically diseased tissue, S100A4 is inappropriately activated which leads to persistent inflammation and non-resolving tissue fibrosis. The company’s lead candidate, AX-202, is a fully humanized, high-affinity monoclonal antibody neutralizing the bioactivity of S100A4. AX-202 confers targeted, upstream and disease-specific modulation of the self-sustaining feedback loop driving persistent fibrogenesis. An ongoing phase 1 trial is designed to establish safety and tolerability of AX-202 in healthy volunteers and patients with psoriasis and is being conducted at the Medicines Evaluation Unit in Manchester, UK in cooperation with CRO-Solutions.

SOURCE: Arxx Therapeutics