Cyxone explores expanding into new regions to mitigate potential delay in Covid-19 trial completion
Cyxone initiated a clinical trial in Eastern Europe with Rabeximod as a treatment for patients with moderate Covid-19 in January 2021. Approximately 90 patients have been successfully enrolled to date. With the declining number of hospitalized Covid-19 patients in Eastern Europe, Cyxone is now considering opening up trial sites in more countries and has had to push back the projected study readout later than Q3 2021.
After discovering that the rheumatoid arthritis drug candidate Rabeximod, could be effective in patients with moderate Covid-19, Cyxone started a Phase 2 clinical trial in Eastern Europe in January 2021. At the start of the trial, the intensity of the pandemic lead to high numbers of severe patients at the hospitals. Despite a lower number of moderate patients in the hospitals, Cyxone has now successfully engaged 21 trial sites in 5 countries and enrolled approximately 90 patients to the study. Furthermore, the Data Monitoring Committee has confirmed that there are no safety issues in the trial so far and therefore approve the trial continuation.
Due to the progression of vaccination plans and the seasonal nature of the virus, the number of hospitalized Covid-19 patients is now dropping in Eastern Europe.
“In contrast to conventional studies where you expect a certain recruitment rate on which timelines are planned, Covid-19 studies are at the mercy of how the pandemic is developing. We therefore need to be agile and adjust to that. We can see that we currently are not meeting the expected recruitment rate, affecting the expected milestones of the study. We know that the infection rates are dropping in Eastern Europe and for that reason we’re investigating an expansion of the study to the southern hemisphere and other regions where infection rates are high today or increasing.” says Carl-Magnus Högerkorp, COO of Cyxone.
The impact on the overall timelines for the study is difficult to assess at this point. However, Cyxone believes an expansion of the study to new countries will mitigate some of the time loss in patient recruitment. In addition, the company has received projections that the slow recruitment in Eastern Europe may increase towards the autumn when people return from travelling and the weather turns colder. The company sees a need to press forward with the study as it is also possible that the delta variant will give rise to a new spike in infection rates.
“We have also received information that younger patients with less severe symptoms are now being admitted to hospitals more in line with the patient group we are including in the study. These can be patients that have even received one vaccine shot.” says Tara Heitner, CEO of Cyxone. “We need to stay vigilant and press on with our study as the delta variant is spreading. The UK opened for one month and then was locked down again due to the emergence of the delta variant and it is now spreading in the USA, so we need to follow the developments closely and be ready to adapt to the new circumstances. We see an important opportunity to now expand the study to countries in the south where high infection rates are creating a crisis and where there is thus a very high unmet need.”
As previously communicated, Cyxone has a registered IND for Rabeximod as a treatment for Covid-19 with the US FDA. This means the company can seek approval to run Covid-19 clinical trials or trials for other indications for Rabeximod in USA, and will facilitate clinical trial applications in other regions.
Tara Heitner, CEO
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This information is information that Cyxone AB (publ) is required to make public pursuant to the EU’s Market Abuse Regulation. The information was submitted for publication by the contact person above on June 30, 2021, at 08.55 CEST.
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, firstname.lastname@example.org. For more information, please visit www.cyxone.com