Cyxone receives pre-IND response from the US FDA regarding RA study
Cyxone (publ), a biotech company in autoimmune diseases, has received a response from a Type B pre-IND meeting with the US Food and Drug Administration (FDA) regarding the upcoming study with the drug candidate Rabeximod, which is in development as a treatment for rheumatoid arthritis (RA).
“We are pleased to now have received a written response from the pre-IND interaction we have had with the FDA and as expected they provided very valuable advice both regarding our preclinical and clinical development activities which ensure a continued adequate way forward for Rabeximod in RA. The FDA is an invaluable asset for development companies like Cyxone”, says Carl-Magnus Högerkorp, acting CEO, Cyxone.
The response from the FDA facilitates for Cyxone to continue planning the phase 2b study with Rabeximod in RA.
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
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, email@example.com. For more information, please visit www.cyxone.comOpen Press release