Cyxone announces positive results from regulatory toxicology studies of Rabeximod

Cyxone (publ.), a Swedish biotech company developing disease modifying therapies for disorders of the immune system, today announced that the six-month regulatory toxicology studies of its drug candidate Rabeximod has been successfully concluded. A read-out of the study results shows a favorable safety profile for Rabeximod, thus enabling longer clinical studies in patients up to six months. Cyxone will now take the next step toward the initiation of a Phase 2 study in rheumatoid arthritis patients.

The concluded six-month toxicology studies in two species are obligatory evaluations demanded by regulatory authorities prior to initiating longer-term clinical studies of Rabeximod. The positive study read-out shows a favorable safety profile of the candidate drug, thus enforcing similar outcomes found in a previously conducted twelve-week toxicology study. The new results will enable Cyxone to conduct clinical studies in patients ranging up to six months, in comparison to previous data supporting studies up to three months. The combined results will be fundamental in guiding the design of the planned Phase 2 study in rheumatoid arthritis (RA) patients set to start in late 2021.

While the company’s toxicology studies were ongoing, preparations of GMP quality API and capsules for future studies have been prepared and start up activities for a trial in Covid-19 patients were initiated. In September, the API production of Rabeximod was finalized and the study drug was subsequently formulated in accordance with GMP (Good Manufacturing Practice). The company therefore has a healthy stock of GMP quality API and capsules for all planned clinical studies have been prepared.

“We are happy to announce the positive study outcomes, an instrumental part of the preparations for the Phase 2 study in RA patients set to start late next year. Equally, we are eagerly looking forward to the imminent initiation of our clinical study of Rabeximod in Covid-19 patients. Combined with the new patent applications recently filed, with potential to substantially prolong market exclusivity, and with a stockpile of drug substance enabling further clinical studies beyond those currently in the pipeline, we stand with a strong foothold in future partnering negotiations. All in all, Cyxone is well-positioned for the development of safe and innovative treatments toward serious immune system disorders,” says Tara Heitner, CEO, Cyxone.

Contact

Tara Heitner, CEO
Tel: +46 (0) 707 81 88 08
Email: tara.heitner@cyxone.com

About Cyxone

Cyxone AB (publ) (Nasdaq First North Growth Market: CYXO) develops disease modifying therapies for disorders of the immune system such as rheumatoid arthritis, multiple sclerosis, as well as a treatment for virally induced respiratory disorders. Rabeximod is a Phase 2 therapeutic candidate with a unique mode of action in rheumatoid arthritis and treating moderate Covid-19 infections. T20K is a Phase 1 therapeutic candidate 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.