Swedish biotech company Cyxone (publ) announced on Friday that it filed its first regulatory application with the Central Ethics Committee (CEC) in Poland for permission to start a clinical phase IIb trial with its drug candidate Rabeximod for the treatment of rheumatoid arthritis (RA).

This will be followed by an application to the Competent Authority in Poland in the Q3 2019 as well as to relevant regulatory authorities in additional European countries.

The regulatory preparation is supported by the renowned RA authority and key opinion leader prof. Désirée van der Heijde to ensure state-of-the art quality of the trial.

According to the company, Rabeximod is an oral drug candidate in development for the treatment of moderate to severe active rheumatoid arthritis (RA) for patients who have previously been treated with methotrexate with inadequate response.

In conjunction, the multi-centre clinical phase IIb trial with Rabeximod in RA is expected to start recruitment of patients in the first half of 2020, added the company.

Under the multi-centre, randomised, double-blind, placebo-controlled clinical trial, the 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 Rabeximod's therapeutic effect as well as good safety and tolerability. The additional toxicology studies are scheduled to be initiated during the second half of 2019, concluded the company.