Siltuximab is an interleukin (IL)-6 targeted monoclonal antibody indicated to treat multicentric Castleman disease (MCD) in patients without HIV or human herpesvirus-8.
Amid the ongoing Covid-19 pandemic, the drug is being assessed as a potential treatment for serious respiratory complications caused by the novel coronavirus.
The SISCO study is sponsored by the Papa Giovanni XXIII Hospital in Italy.
According to interim findings from the first 21 patients who were followed for up to seven days, siltuximab led to clinical improvement in seven patients with decreased need for oxygen support.
The condition of nine participants stabilised without any clinically relevant changes.
Based on the data, the company concluded that 16 patients on siltuximab were stable or had improved disease at the interim analysis.
Meanwhile, three patients experienced worsening of the disease, one had a cerebrovascular event, and one died.
EUSA Pharma also reported a decrease in C-Reactive Protein (CRP) levels from baseline to day five after treatment with siltuximab in all 16 patients. CRP is a marker of systemic inflammation.
The decrease was maintained for seven days following treatment.
EUSA Pharma CEO Lee Morley said: “We are very pleased to be able to release these preliminary data from the SISCO Study and hope the findings will help to guide real-world treatment decisions during this critical emergency situation.
“We look forward to engaging in further studies to research the potential of siltuximab for patients suffering severely with respiratory complications from Covid-19 and making additional data available as soon as possible.”
The study has enrolled a total of 25 patients with confirmed Covid-19 and respiratory complications.
In the coming weeks, the company expects to announce the next phase of data based on the comparison of outcomes in matched case-control patients who did not receive siltuximab.