Poland Launches Oral Treatment Study for COVID-19 Patients
A Sweden based company announced it had received approval from the regulatory authority and the ethics committee in Poland to initiate a Phase 2 clinical trial with Rabeximod for moderate COVID-19 patients.
This study will evaluate Cyxone AB’s oral treatment is intended to prevent the progression to acute respiratory distress symptoms caused by virus-related overactivation of the immune system.
Most individuals infected with COVID-19 experience only mild symptoms. However, there is a risk that the immune system overreacts in some patients, triggering a disproportionate release of cytokines and chemokines, leading to hyper-inflammation and severe respiratory failure.
Cyxone is contracting several clinical sites in Poland, and preparations are in place to expediently initiate patient inclusion. In parallel, the company has filed for regulatory approval in Slovakia and is preparing for submissions in additional countries.
To evaluate the efficacy of the candidate drug, 300 patients suffering from moderate COVID-19, in need of oxygen treatment but not ventilator treatment, will receive one of two doses of Rabeximod or placebo in a double-blinded study. Cyxone aims to present preliminary study data in Q3 2021.
"We are pleased to initiate soon our Phase 2 study in which we aim to develop an oral treatment for moderate COVID-19 patients, preventing the progression to acute symptoms avoiding the need of intensive care treatment and relieving the burden on hospitals and healthcare systems,” commented CEO Tara Heitner.
“Given a successful outcome, Rabeximod could be developed as a candidate drug not only for Covid-19 but for the treatment of other disorders of the immune system, including virally induced acute respiratory disorders.”
Cyxone AB 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 currently undergoing phase II clinical testing in various European countries. For more information, please visit Cyxone.
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