Researchers from the University of Geneva (UNIGE) and Geneva University Hospitals (HUG) in Switzerland have conducted a clinical study to investigate a new interleukin-18-inhibiting drug for the treatment of patients with Still’s disease.
The interleukin-18 (IL-18) protein is known to be involved in immune and inflammatory responses, and Still’s disease is a serious orphan condition caused due to deregulation of immune system that leads to an acute inflammatory response. The disease is characterised by abnormal levels of IL-18.
Results from the study are reported to have indicated positive safety and efficacy profile of the new drug, which was acquired by a Swiss start-up AB2 Bio, after being abandoned by a pharmaceutical company due to inconclusive test data against rheumatoid arthritis and psoriasis.
During the latest study, 23 subjects with different forms of Still’s disease were administered with thrice-weekly 80mg or 160mg subcutaneous injections of the new drug over 12 weeks.
The researchers found few serious side effects, of which only one is believed to be associated with the drug. Also, half of the subjects are reported to have demonstrated positive response over the treatment period and reduced symptoms during 12 weeks of follow-up.
UNIGE Faculty of Medicine professor Cem Gabay said: “In contrast, patients who didn’t have a positive 80mg response did not have one with 160mg either.
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By GlobalData“These first results are extremely encouraging and mean we can plan a Phase III trial to better evaluate the effectiveness of the drug.”
The ongoing Phase II trial is designed to validate the drug’s safety and establish an optimal dose, while the subsequent Phase III trial will evaluate its efficacy.
Furthermore, the researchers expect that the new drug could also aid in treating other rare inflammatory diseases that involve dysregulated IL-18 production.