Arana Therapeutics Limited announced that it has submitted Regulatory and Ethics approvals for a pilot study of ART621 in rheumatoid arthritis (RA). The randomised double-blind trial - designated ART621/223 - will compare four different dose regimens of ART621 and is designed to quickly obtain initial safety and efficacy data in this patient population.
Interim data from this study will be used to optimize the dosing regimen for ART621/221 - the international multi-centre Phase II dose ranging RA study.
Study ART621/223 is a factorial-design, randomised, 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 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 centre in Sri Lanka and will aim to enroll approximately 20 patients.
Arana's Acting CEO Dr Steffen Nock 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" he added.
Arana Therapeutics is a biopharmaceutical company focussed on developing next generation antibody based drugs that will improve the lives of patients with inflammatory diseases and cancer.