Cyxone files regulatory submission to start clinical phase 2b study with Rabeximod
Cyxone (publ), a biotech company in autoimmune diseases, today filed a submission to the National Institute of Pharmacy and Nutrition (OGYEI) - the Hungarian Medical Product Agency - 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). This first submission will be followed by applications to relevant regulatory authorities in other European countries.
The submission to the Hungarian Regulatory Authority OGYEI for approval to start a clinical phase 2b trial with Cyxone’s drug candidate Rabeximod in RA has now been filed, which marks the first regulatory step towards study start.
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.
”We are pleased to announce that we now take the next step in the preparations to start our phase 2b study with Rabeximod in RA. After a solid work to develop an optimal study design we now feel that we have a robust plan in place and I am looking forward to starting the study as soon as we have all the approvals in place. We are hopeful to receive the necessary regulatory green light and will make further announcements on the study achieved milestones. We believe that with a favourable safety profile and potential improvement of patients’ quality of life as well as compounded by an improved cost effectiveness profile, Rabeximod could potentially close a remaining gap in the management of RA patients since many decades.” says Carl-Magnus Högerkorp, acting CEO, Cyxone.
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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