The follow-up study was designed to evaluate Lupuzor’s safety and tolerability, and the drug passed with flying colours, with no serious adverse events reported.
On top of that, ImmuPharma was also able to show that a third of the patients taking the drug were in remission at the end of the study.
“We are delighted that Lupuzor has again confirmed its robust safety profile and we are confident that Lupuzor has the potential to bring a much-needed treatment to Lupus sufferers around the world,” said chairman Tim McCarthy.
Building knowledge of drug
The follow-up study came about after Lupuzor missed its primary endpoint in a phase III trial last year.
But the outcome was more nuanced than the top line results suggested and actually showed that Lupuzor worked well in certain patients, chiefly those who were antibody positive.
Since then, ImmuPharma has been building a data package for the drug in order to boost its chances of regulatory success further down the line.
As well as the extension study, 500 lupus sufferers are being given access to Lupuzor for the next two years as part of a managed access programme (MAP).
After the success of the latest study, if Lupuzor can prove itself again in the MAP, ImmuPharma will look to use the data to get full regulatory approval for the drug, something bosses have previously said they hope to achieve “in the medium term”.
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