Ablynx’s vobarilizumab trial fails and sees two patient deaths in systemic lupus erythematosus
Ablynx has revealed that its interleukin 6 pathway via its IL-6 receptor (IL-6R) vobarilizumab failed to meet its primary endpoint in a Phase 2 trial, presenting implications for Sanofi who will acquire the drug following its agreement to buy the firm for $4.8 billion.
In the 312-strong study of patients with moderate to severe, active seropositive systemic lupus erythematosus (SLE), the therapy failed to demonstrate a dose response based on the modified BILAG-based combined lupus assessment (mBICLA) in all four of its treatment arms after 24 weeks compared to placebo. On top of this, the deaths of two participants were reported after being treated with vobarilizumab.
“We are disappointed that vobarilizumab didn’t show a dose response in the analysis of the study’s primary endpoint, however, vobarilizumab was well tolerated in all tested dose groups, confirming its favourable safety profile,” said Dr Robert K Zeldin, Chief Medical Officer at Ablynx. “We will continue to analyse the full data set and thank the study participants and their families as well as the investigators and staff who contributed to this study.”
SLE is a condition characterised by the production of pathogenic autoantibodies and tissue deposition of immune complexes which can lead to prevalent tissue damage in patients. The disease affects around five million patients worldwide, with 90% of the affected being female.
While it was not a main driver of the deal between Sanofi and Ablynx, the news will taint the value that the French drugmaker could have found in the drug, and makes it that little bit harder for it to recoup its total investment. Ablynx still holds full authorisation to market the drug in rheumatoid arthritis after picking it up from Abbvie in 2016, but the latter firm could still exercise its option to license the drug in SLE, though these latest data could mean it could have real trouble finding success in the space.
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