Swedish Cyxone has submitted an application to the CEC in Poland for permission to start a clinical phase IIb trial with Cyxone’s drug candidate Rabeximod in RA, marking the first regulatory step towards the initiation of the study.
Cyxone said that 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, Cyxone said in the statement.
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, Cyxone said. Additionally, Cyxone said it 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.
Kjell G. Stenberg, CEO of Cyxone, said that a lot of important pieces have fallen into place this year, and that the company has negotiated with and contracted a number of key partners ahead of this submission to CEC in Poland. “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,” said Stenberg.