Cyxone receive ethical and regulatory approval from Hungary to start clinical Phase 2b study in RA

Cyxone (publ), a biotech company in autoimmune diseases, have received approval from the Hungarian Central Ethics Committee and the Medical Product Agency - National Institute of Pharmacy and Nutrition (OGYEI) to start a clinical Phase 2b study - APPRAIS - with its drug candidate Rabeximod, which is being developed as a treatment for rheumatoid arthritis (RA).

APPRAIS 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 immensely pleased that an ethical and regulatory approval has been obtained from the Hungarian authorities. It is another important step forward for our study with Rabeximod in rheumatoid arthritis. It is also a recognition of our amazing Cyxone team and collaborators behind the study design of APPRAIS. The Hungarian authorities gave approval to the study without any reservations, which is a significant sign of strength. With this, we feel great confidence for the upcoming study start.” says Carl-Magnus Högerkorp, acting CEO, Cyxone.

Rabeximod is a well-tolerated, orally available Phase 2 candidate drug with a unique mechanism of action. Rabeximod selectively targets the inflammatory macrophage, a type of white blood cell which is the central orchestrator of the inflammatory process that causes tissue destruction and clinical symptoms in RA. Combined with the convenience of oral administration and a beneficial tolerability profile, this opens up for treatment in the early as well as later stages of the disease. It is believed to be particularly effective at onset and relapses of RA, with good potential to prevent joint destruction and progression of the disease.

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. For more information, please visit www.cyxone.com