*A first in human, single and multiple ascending dose study of AX-202
Research type
Research Study
Full title
A first-in-human, randomised double-blind, placebo-controlled 2-part study to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of single ascending doses of AX-202 in healthy subjects and multiple ascending doses of AX-202 in patients with mild to moderate chronic plaque psoriasis.
IRAS ID
1006661
Contact name
Sylvia Vetrhus
Contact email
Sponsor organisation
Arxx Therapeutics
Eudract number
2022-002534-13
ISRCTN Number
ISRCTN79668046
Research summary
The Sponsor, Arxx Therapeutics, is developing a new experimental medication called AX-202 for the purpose of treating inflammatory diseases (when the immune system attacks the body's own tissues, resulting in inflammation) and fibrotic diseases (diseases caused by the thickening or scarring of tissue).
Psoriasis is a chronic, relapsing inflammatory disease of the skin affecting approximately 1-3% of the world’s population. The most common form is plaque psoriasis representing 80-90% of all cases. Plaque psoriasis is defined by well-defined red, scaly plaques or patches which can occur anywhere on the body.
The immune system normally defends the body against harmful substances, diseases and infections. However, in people who have an autoimmune disease such as psoriasis, the immune system becomes overactive and attacks its own healthy cells.
S100A4 is a protein released in the body which can cause harm, contributing to over-activation of the immune system (inflammation) and tissue damage in diseases like psoriasis. AX-202 is a type of medication called a ‘monoclonal antibody’, which are antibodies designed to specifically bind to a disease-causing protein. AX-202 binds to and blocks the activity of S100A4, so may reduce inflammation and tissue damage in psoriasis.
This is the first study with AX-202 in humans and is designed to determine whether the drug is safe and well tolerated in healthy participants (Part A) and people with plaque psoriasis (Part B). The following will also be investigated:
• Pharmacokinetic blood analysis (levels of AX-202 in the body)
• Immunogenicity in blood (to see if the body is making antibodies against AX-202)
• Target engagement in blood and urine (interaction of AX-202 with its target protein ‘S100A4’)
• Biomarker analysis (which looks at specific biological features of the blood and skin)
• Disease activity in patients will be assessed using scoring systems (Part B only)REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0333
Date of REC Opinion
2 Mar 2023
REC opinion
Further Information Favourable Opinion