Cyxone has announced the screening of the first participant in the Phase II clinical trial to evaluate Rabeximod for treating Covid-19 patients.
The trial is analysing the efficacy and safety of oral treatment with Rabeximod to avert disease progression in hospitalised Covid-19 patients and reduce the recovery time.
It will enrol 300 patients at clinical centres in Poland, Slovakia and up to three additional countries in Europe.
The company intends to report preliminary results from the trial in the third quarter of this year.
Cyxone CEO Tara Heitner said: “Therapeutics like Rabeximod have the potential to save lives in this pandemic and in future pandemics involving viral infections of the lungs.
“While several vaccines are now becoming available, there will always be a need for therapies for patients who cannot take a vaccine, unknowns such as limited duration of effect or loss of effect caused by potential viral mutations as well as other viral infections such as influenza, SARS and viruses yet to emerge.”
Cyxone earlier reported that the company received regulatory approval to begin a double-blind placebo-controlled Phase II trial of Rabeximod in Poland, where the first site was opened last month.
The company has also submitted an application seeking regulatory approval in Slovakia, Hungary and Ukraine and further intends to seek permission in additional countries.
The drug is currently analysed in moderate Covid-19 patients who require oxygen treatment but not a ventilator.
The company noted that Rabeximod’s new way of action in controlling hyperactivated immune cells in the lung could potentially prevent progression to acute disease.
On obtaining positive study results, Cyxone plans to seek emergency use authorisation on getting a strategic partner.
Furthermore, the company will work on developing Rabeximod for treating Covid-19, other virally induced respiratory diseases, as well as rheumatoid arthritis.