Artax Biopharma has obtained clinical trial authorisation (CTA) from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to assess AX-158 in a Phase IIa study in psoriasis patients.
With the approval, the company intends to commence subject enrolment by the end of this year at study centres in the UK.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The double-blind, randomised, placebo-controlled, proof-of-concept trial is designed to assess the tolerability and safety of AX-158 versus placebo in patients with mild to moderate plaque psoriasis.
Subjects will be randomised into a 2:1 ratio to receive AX-158 or a placebo.
The trial will enrol 30 participants who will receive the treatment for 28 days and a subsequent dosing for another additional 30 days.
An investigational oral, small molecule immunomodulator, AX-158 can adjust T cell responses vital in the healthy functioning of the immune system.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIt can also regulate various cytokines that cause diseases without needing immunosuppression.
Artax Biopharma CEO Joseph Lobacki said: “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.
“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.”
