Cyxone announces Rabeximod in Covid-19 Phase 2 trial closed, data to be reported in Q3

Cyxone today announced that the Rabeximod in Covid-19 trial that has been conducted in Eastern Europe during Q1-Q2 2021 will be closed as the trial has been shown to have a sufficient number of patients enrolled to allow for statistical analysis.

Recently Cyxone reported that patient recruitment for the clinical study conducted in Covid-19 patients in Eastern Europe was challenged as Covid-19 cases declined and a study delay was predicted. Approximately 90 patients have been enrolled into the trial to date, and after reanalysis of the statistical requirements for study size it has been concluded that the trial currently has sufficient patients to power an analysis of effect of Rabeximod over placebo. The Cyxone Covid-19 clinical trial study results will be reported in Q3 2021.

After discovering that the rheumatoid arthritis drug candidate Rabeximod, could be effective in patients with moderate Covid-19, Cyxone started a Phase 2 clinical trial in Eastern Europe in January 2021. Despite the rapidly changing landscape for patient recruitment during the spring of 2021, by June 20201 Cyxone has successfully engaged 21 trial sites in 5 countries and enrolled approximately 90 patients to the study, demonstrating the company was well positioned to perform in this previously unchartered clinical trial market.

In May 2020 during the beginning of the Covid-19 pandemic the Cyxone clinical trial was envisioned. With very limited data available at that time, the trial was designed to include 300 patients. After a statistical reanalysis by experts in biostatistics it is now concluded that the original study design was over dimensioned and that the 90 patients enrolled is sufficient for a study readout based on the most recent knowledge.

“I am very happy to report that we can conclude the Rabeximod in Covid-19 Phase 2 clinical study and initiate data analysis. We otherwise needed to make the decision to open sites in other regions where the Covid-19 pandemic is still raging. This would be possible but require more time and resources. Now we understand that expanding the trial is not needed. The readout from this study will yield important information that will guide development of Rabeximod for treatment of ARDS which Covid-19 and other viral infections of the lung establishes. Furthermore, we remain on track to report the study outcome by the end of Q3”, says Tara Heitner, CEO of Cyxone AB.  ”With this study concluded we focus all our resources on the ongoing start-up activities for the Rabeximod in RA trial and our preclinical activities for T20K.”

Tara Heitner, CEO
Tel: +46 (0)70 781 88 08
Email: tara.heitner@cyxone.com

Cyxone AB (publ) (Nasdaq First North Growth Market: CYXO) develops disease modifying therapies for diseases such as rheumatoid arthritis and multiple sclerosis as well as treatments for virally induced acute respiratory disorders. Rabeximod is a Phase 2 candidate drug being evaluated for the management of rheumatoid arthritis and moderate Covid-19 infections. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. Certified Adviser is Mangold Fondkommission AB, +46 (0)8 503 015 50, ca@mangold.se. For more information, please visit www.cyxone.com