Cyxone files submission to start clinical Phase 2b study in Poland and Georgia
Cyxone (publ), a biotech company in autoimmune diseases, have now filed submissions to the Office for Registration of Medicinal Products, Medical devices and Biocides and the Central Ethics Committee in Poland as well as at local Ethics Committees in Georgia for approval to start a clinical Phase 2b study with its drug candidate Rabeximod, which is being developed as a treatment for rheumatoid arthritis (RA).
The submissions to the Regulatory Authorities and the responsible Ethical Committees in Poland and Georgia for approval to start a clinical phase 2b trial with Cyxone’s drug candidate Rabeximod in RA have now been filed.
“Cyxone continues the start-up activities for the upcoming Phase 2b trial with Rabeximod in RA. Every regulatory interaction is very important for us, and we look forward to positive outcomes. I am extremely pleased with the work that has led to us to this point of submitting these applications. We have a very strong and competent team in place that drives the preparatory work forward in an excellent way together with our contracted CRO.” says Carl-Magnus Högerkorp, acting CEO, Cyxone.
The study is a multicenter, randomised, double-blinded, placebo-controlled clinical study where patients with moderate to severe RA, who have previously been treated with methotrexate with inadequate response, will be treated with Rabeximod for 24 weeks. The aim of the study is to confirm the therapeutic efficacy of Rabeximod in this patient population, as well as to expand the safety data documentation.
Contact
Carl-Magnus Högerkorp, acting CEO
Tel: +46 (0)70 781 88 12
Email: carl.hogerkorp@cyxone.com
About Cyxone
Cyxone AB (publ) (Nasdaq First North Growth Market: CYXO) develops disease modifying therapies for diseases such as rheumatoid arthritis and multiple sclerosis. Rabeximod is a Phase 2 candidate drug being evaluated for the management of rheumatoid arthritis. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. Certified Adviser is FNCA Sweden AB, +46(0)8-528 00 399, info@fnca.se. For more information, please visit www.cyxone.com
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