Cyxone has filed an IND in the US with Rabeximod following positive feed-back from pre-IND meeting with the FDA

STOCKHOLM, Dec. 15, 2020

Cyxone recently held a constructive pre-IND meeting (type B meeting) with the FDA, and the authority's advice has been incorporated in the study protocol for the clinical study of Rabeximod in Covid-19, which is expected to be initiated shortly in Europe. The filing of an IND will enable participation of US medical centers in future clinical studies of Rabeximod in Covid-19, rheumatoid arthritis and potential other indications. The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies. In Covid-19, Rabeximod is positioned as an oral treatment of moderately diseased patients - a group that is not addressed by current standard of care therapeutics.

"Filing an IND with the FDA is an important step in the clinical development of Rabeximod. It is a quality stamp on our drug candidate and Covid-19 trial and would enable us to expand the clinical development to the United States. Even as vaccines are becoming available, safe and convenient treatments for Covid-19 will be required to lower the death toll of the current global health emergency and to be better prepared for future pandemics", said Cyxone's CEO, Tara Heitner.

Cyxone recently announced that the company had received regulatory approval to initiate a randomized, placebo controlled, double blind, Phase 2 clinical trial of Rabeximod in Poland. In parallel, the company has submitted a Clinical Trial Application in Slovakia and is preparing for submissions in additional countries. Rabeximod will be evaluated in patients suffering from moderate Covid-19 in need of oxygen treatment but not ventilation support. In the study, 300 patients will receive Rabeximod orally at one of two dose levels or placebo for 14 days after which Cyxone will evaluate the study outcome. Cyxone aims to announce top-line results from the study in the third quarter of 2021.

"We look forward to initiating the Phase 2 study in Covid-19 patients as soon as possible, to provide important information about the safety and efficacy of Rabeximod in an acute setting", said Cyxone's Chief Operating Officer, Malin Berthold.

Contact

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