Cyxone Submits First Application to Start Rabeximod Clinical Trial

Cyxone has submitted an application to the Central Ethics Committee (CEC) in Poland for permission to start a clinical phase IIb trial with its drug candidate Rabeximod, which is in development for the treatment of rheumatoid arthritis (RA). This first application will be followed by an application to the Competent Authority in Poland during the third quarter of 2019, and subsequently, by applications to the relevant regulatory authorities in additional European countries. The multi-center clinical phase IIb trial with Rabeximod in RA is expected to start recruitment of patients in the first half of 2020.

The application to the CEC in Poland for permission to start a clinical phase IIb trial with Cyxone's drug candidate Rabeximod in RA has now been submitted, marking the first regulatory step towards the initiation of the study. The CEC in Poland are expected to provide an initial response during the third quarter of 2019, followed by a potential approval during the second half of 2019. The preparation has been supported by the renowned RA authority and key opinion leader prof. Désirée van der Heijde as a contracted scientific advisor, in order to ensure state-of-the art quality of the trial. Additionally, Cyxone is filing an application with the Competent Authority in Poland, and in parallel, are working to complete required documentation needed by the regulatory bodies in up to eight additional European countries.

"We are very pleased to finally be able to share our progress with Rabeximod. This spring, a lot of important pieces have fallen into place and we have negotiated with and contracted a number of key partners ahead of this submission to CEC in Poland," Kjell G. Stenberg, CEO of Cyxone, said. "Through our hard work this spring, including receiving extremely valuable input from the esteemed prof. van der Heijde, we have created the best possible conditions for confirming Rabeximod's effect in a second phase II trial, and I truly look forward to initiating the study."

The trial is a multi-center, randomized, double-blind, placebo-controlled clinical trial 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 Rabeximod's therapeutic effect as well as good safety and tolerability. Before patients are treated with Rabeximod for 24 weeks, Cyxone must conduct additional preclinical toxicology studies with the substance to confirm its safety for 24 weeks of treatment. The additional toxicology studies are scheduled to be initiated during the second half of 2019. As safety data for 12 weeks of treatment with Rabeximod already exist, the clinical phase IIb trial could potentially be initiated before the finalization of the toxicology study. The company will announce the response from the appropriate authorities once received and make further announcements as the preparations for the study advances.

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. The candidate has demonstrated a therapeutic effect in a placebo-controlled clinical phase II study in RA comprising more than 200 patients. The study was designed to measure the effect of Rabeximod after 12 weeks of treatment, although a statistically significant effect was only achieved four weeks after the stipulated study time (in week 16). The upcoming planned clinical phase IIb trial aims to confirm the effect with a 24-week study.

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