Alfasigma plans to engage with regulators to seek approval for Jyseleca (filgotinib) in active axial spondyloarthritis (axSpA) following a successful Phase III trial.
In the OLIGUITO study (NCT05785611), Jyseleca met the primary endpoint of achieving SpondyloArthritis International Society 40% improvement (ASAS40) response. Efficacy was demonstrated across the full spectrum of axSpA, including both radiographic (r-axSpA) and non-radiographic (nr-axSpA) forms.
The safety profile remained consistent with previous studies, with no unexpected events observed.
Professor Xenofon Baraliakos, Rheumazentrum Ruhrgebiet's head of rheumatology, said: “The burden of disease for these patients remains high as treatment options are limited. It is therefore encouraging that the primary endpoint for both axSpA indications was met in dedicated studies.”
Alfasigma will submit the Phase III data to the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to seek market authorisation for Jyseleca in axSpA. It has not disclosed its plans to the US regulator.
Jyseleca, a once-daily oral JAK1 preferential inhibitor, is already approved for the treatment of moderate to severe active rheumatoid arthritis (RA) and ulcerative colitis (UC). The drug was first approved by the EMA in September 2020 for use in RA.
AxSpA is a chronic inflammatory disease that typically presents when patients are in their 30s, impacting the spine and sacroiliac joints and causing significant pain, stiffness and reduced mobility.
The standard of care (SoC) is a holistic, multidisciplinary approach coordinated by a rheumatologist. Treatment focuses on symptom management, restoring function, quality of life (QoL), and slowing disease progression. Pharmacological interventions include non-steroidal anti-inflammatory drugs (NSAIDs) in the first line, and biological disease-modifying antirheumatic drugs (bDMARDs) for patients with persistently active disease or inadequate response to NSAIDs.
Only 40-50% of patients with axSpA achieve adequate response with current treatments, and an even smaller proportion (approximately 10%-20%) reach remission or an inactive disease activity state within 16 to 24 weeks of treatment initiation.
GlobalData predicts the axSpA market across the seven major pharmaceutical markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) will reach $3.6bn by 2028.
Jyseleca in third development partnership
The development of Jyseleca has seen several shifts in the pharmaceutical industry. The first partnership with the therapy was between original developer Galapagos and Abbot Laboratories in 2012, when the therapy was in Phase II development in RA. However, this deal was terminated by Abbot, which spun out into AbbVie in 2015, as the company decided to pursue its own JAK1 inhibitor Rinvoq (upadacitinib), which was approved in the indication by the US Food and Drug Administration (FDA) in 2019. Rinvoq also beat Jyseleca to the market in axSpA, having gained approval in the indication in 2022.
Gilead then created a partnership with Galapagos in 2015 for the development and commercialisation of the therapy in RA and other inflammatory diseases.
In January 2024, the drug was transferred by Galapagos to Alfasigma, with Galapagos having received a €50m ($57.89m) upfront payment and is in line for potential sales-based milestone payments of €120m and mid-single to mid-double-digit royalties on European sales. Galapagos contributed around €40m to Alfasigma by June 2025 for Jyseleca development.
