Study ART621/223 is a factorial-design, randomized, double-blind, placebo-controlled study to investigate the safety, efficacy, immunogenicity and pharmacokinetics of different dose regimens of ART621 following multiple dose administration in subjects diagnosed with rheumatoid arthritis (RA) concomitantly taking methotrexate.
The primary endpoint of ART621/223 is safety with secondary endpoints including efficacy measures. The study will be conducted at a single center in Sri Lanka and will aim to enroll approximately 20 patients.
Interim data from this study will be used to optimize the dosing regimen for ART621/221 – the international multi-center Phase II dose ranging RA study.
Steffen Nock, Arana’s acting CEO, said: The Sri Lankan study offers the unique ability to rapidly obtain clinical data for the RA indication and also gives us the ability to potentially fine-tune the larger RA study while maintaining our momentum.
The two RA studies combine to give us a cost-effective and risk managed approach to identifying the optimal dose regimen for ART621 in RA. Our psoriasis data is expected in early 2009 and so ART621 is now at a very exciting stage of development with several potential partners closely tracking our progress.