Cyxone receives regulatory approval to initiate a clinical Phase 2 study with Rabeximod in Covid-19 patients

Cyxone (publ.) announced today it has received approval from the regulatory authority and the ethics committee in Poland to initiate a Phase 2 clinical trial with Rabeximod in moderate Covid-19 patients. The oral treatment is intended to prevent the progression to acute respiratory distress symptoms (ARDS) caused by virus-related overactivation of the immune system. Preliminary results are expected in the third quarter of 2021.

Most individuals infected with Covid-19 experience only mild symptoms. However, in some patients there is a risk that the immune system overreacts, triggering a disproportionate release of cytokines and chemokines leading to hyperinflammation and severe respiratory failure. The urgent need for safe, effective and easily administered therapies to prevent progression from a moderate to acute disease state was recently emphasized in a JAMA (Journal of the American Medical Association) article by Dr Anthony S. Fauci and two other representatives of the US National Institutes of Health1.

Cyxone is contracting a number of 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.

Due to Cyxone’s recent funding initiatives, the ensuing study is fully financed. Given a positive study outcome, the company plans to enter into a strategic partnership with a global pharmaceutical company in order to further progress the development and commercialization of Rabeximod in Covid-19 and other virally induced respiratory diseases.

"We are pleased to soon initiate 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. 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", comments CEO Tara Heitner.

1Kim PS, Read SW, Fauci AS. Therapy for Early COVID-19: A Critical Need. JAMA. 2020;324(21):2149–2150. doi:10.1001/jama.2020.22813. Read the article: https://jamanetwork.com/journals/jama/fullarticle/2773058

Tara Heitner, CEO
Tel: +46 70 781 88 08
Email: tara.heitner@cyxone.com
Adelgatan 21
211 22 Malmö, Sweden

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.