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Sanofi will halt the development of its oral tumour necrosis factor (TNF) inhibitor balinatunfib as a monotherapy after it failed to reach the primary endpoint in a Phase II trial.
Preliminary results from the SPECIFIC-PSO Phase II study (NCT06073119) in patients with psoriasis showed that balinatunfib achieved clinically relevant changes in the primary endpoint – the PASI-75 response - with efficacy levels comparable to other oral medicines in psoriasis. However, it did not reach statistical significance. Sanofi said this miss was due to “the nature of this limited Phase II study”.
PASI-75 is a commonly used metric which measures whether a patient has benefited from a 75% reduction in symptoms compared to baseline.
As a result of the data, Sanofi believes that balinatunfib could be better suited for investigation as part of a combination therapy. Internal assessments and external discussions are ongoing to determine potential combinations, including fixed-dose combinations in various diseases.
The Phase II randomised, double-blind, placebo-controlled trial enrolled 221 patients with moderate to severe plaque psoriasis who were dosed for 12 weeks.
Despite the negative result, Sanofi reported that balinatunfib was generally well tolerated across doses with no new safety concerns in the study. The data was presented as part of Sanofi’s Q1 2025 earnings.
The company plans to present full data at an upcoming medical meeting.
The drug is also being investigated in Phase II trials in rheumatoid arthritis (NCT06073093), Crohn's disease (NCT06637631) and ulcerative colitis (NCT06867094).
TNF inhibitors first approved 20 years ago
A number of TNF inhibitors have been approved with the most notable being AbbVie’s Humira (adalimumab), which is one of the world’s best-selling drugs of all time. The drug gained approval in 10 indications since it first got US Food and Drug Administration (FDA) clearance in 2002. According to GlobalData, the parent company of Clinical Trials Arena, Humira hit its peak in 2022, reaching $21.59bn in global sales before it lost patent protection.
Since Humira hit the market, other TNF inhibitors have also been approved including Johnson & Johnson’s Remicade (infliximab), Amgen’s Enbrel (etanercept) and UCB’s Cimzia (certolizumab pegol).
"Sanofi axes development of oral TNF inhibitor as monotherapy following Phase II fail" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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