Cyxone initiates early operations with a global contract research organization to conduct Phase 2b trial in rheumatoid arthritis
Cyxone (publ) announces today that the company has initiated an early operations agreement (EOA) with an internationally renowned contract research organization (CRO) to prepare for the upcoming clinical Phase 2b trial of Rabeximod in patients with rheumatoid arthritis. As part of the EOA, the CRO will support Cyxone in start-up and feasibility activities including finalization of the trial protocol and selection of the countries and trial sites that meet the criteria of the trial design.
Cyxone is developing Rabeximod, an oral potential first line treatment for patients suffering from the inflammatory disease rheumatoid arthritis (RA). Currently many patients are underserved as they do not respond to current therapies or stop responding over time. Rabeximod is differentiated from current therapies by suppressing a population of inflammatory cells central to the structural damage of the joints which occurs in RA. By suppressing these cells and by inhibiting the production of proinflammatory signaling molecules critical to drive the inflammatory process, Rabeximod has the potential to treat patients which do not respond to or cannot tolerate other treatments and to prevent the disease progression in a novel and disease modifying manner.
The trial will be randomized and double-blinded, composed by three arms comparing two different dose levels of Rabeximod on top of standard of care to standard of care over a 16-week-treatment period. Patient enrollment is expected to run over 12–18 months.
“As we progress toward a regulatory submission to initiate our Phase 2 trial of Rabeximod, it has been of essence to secure an experienced & trustworthy CRO with a proven global track record in planning, running, and compiling the results from clinical trials. We are happy to be able to initiate these early operational acitivites with the CRO who will support us in optimizing and running all aspects of the upcoming trial. We aim to develop a highly differentiated, safe, and effective treatment to patients suffering from rheumatoid arthritis and for patients underserved by available therapies,” comments Tara Heitner, CEO, Cyxone.
Contact
Tara Heitner, CEO
Tel: +46 70 781 88 08
Email: tara.heitner@cyxone.com
Adelgatan 21
211 22 Malmö, Sweden
About Cyxone
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 FNCA Sweden AB, +46(0)8-528 00 399, info@fnca.se. For more information, please visit www.cyxone.com
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