Alfasigma has announced positive topline results from its OLINGUITO phase 3 trial evaluating filgotinib in adults with active axial spondyloarthritis (axSpA), including both radiographic and non-radiographic forms.
Filgotinib met the primary endpoint, demonstrating efficacy across the full axSpA spectrum. The safety profile was consistent with previous studies, with no unexpected events reported.
The company plans to submit the data to the European Medicines Agency and the UK’s Medicines Healthcare products Regulatory Agency to seek market authorisation for filgotinib in axSpA.
Filgotinib is an oral, once-daily JAK1 preferential inhibitor currently approved for moderate to severe active rheumatoid arthritis and ulcerative colitis.
Daniele D’Ambrosio, Chief Development Officer at Alfasigma, said: “These positive OLINGUITO topline results demonstrate filgotinib’s potential to address this critical unmet need for patients with axial spondyloarthritis, with only half responding adequately to current therapies.”
He added: “Based on these encouraging results, we intend to submit for an extension of filgotinib’s current indications, offering a potential new treatment option for patients with axial spondyloarthritis who often struggle with debilitating symptoms from a young age.”
Professor Xenofon Baraliakos, Ruhr-University Bochum, said: “These results from the OLINGUITO phase 3 clinical trial clearly support the potential of filgotinib as a treatment option for patients living with axSpA at all stages of the disease.”
AxSpA is a chronic inflammatory condition affecting the spine and sacroiliac joints. It typically emerges in early adulthood and causes pain, stiffness and reduced mobility.
Despite available therapies, only 40% to 50% of patients achieve a meaningful response, with just 10% to 20% reaching remission or inactive disease status within 16 to 24 weeks of treatment.
