Alfasigma presents first data on filgotinib from the Phase 3 OLINGUITO trial in axial spondyloarthritis at EULAR 2026

The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific and investor media only.In the OLINGUITO Phase 3 study in radiographic (r) and non-radiographic (nr) axial spondyloarthritis (axSpA) a significantly greater proportion of patients achieved the prespecified primary endpoint of ASAS40 with filgotinib compared with placebo at week 16.The improvements in signs and symptoms of axSpA with filgotinib, an oral, once-daily JAK1 preferential inhibitor, were observed as early as week 1 and maintained over 52 weeks of treatment.In the r-axSpA and nr-axSpA filgotinib groups, of those achieving a response in the prespecified primary endpoint of ASAS40 at week 16, 84.6% and 78.0% maintained their responses to week 52, respectively.In OLINGUITO no new safety signals were observedfor filgotinib over 52 weeks, and the safety profile was consistent with the known overall safety profile.Primary results from the Phase 3 OLINGUITO trial were accepted by EULAR for oral presentation (Thursday 4 June).

Alfasigma S.p.A, a global pharmaceutical company with a focus on innovation in rare and specialty care where there is significant unmet patient need, presented positive results from the OLINGUITO Phase 3 clinical trial (NCT05785611ⁱEudraCT 2022-501354-10-01ⁱⁱ) at EULAR 2026. In OLINGUITO filgotinib, an oral, once-daily JAK1 preferential inhibitor under investigation for the treatment of adult patients with active axial spondyloarthritis (axSpA), demonstrated sustained improvements in the signs and symptoms of axSpA, including disease activity and inflammation.ⁱⁱⁱ Safety was consistent with the known profile of filgotinib, indicating a favourable benefit-risk profile for patients with active axSpA.ⁱⁱⁱ

The OLINGUITO trial consists of two international, randomised, double-blind, placebo-controlled studies (Study A and Study B), evaluating the efficacy and safety of filgotinib 200mg once-daily vs. placebo in patients with an established diagnosis of axSpA as per ASAS classification.ⁱ Eligible patients who had an established diagnosis of axSpA, met the Assessment of SpondyloArthritis international Society (ASAS) classification for radiographic (r) (Study A) or non-radiographic (nr) axSpA (Study B), and had an inadequate response or intolerance to conventional treatments.ⁱ In each study, filgotinib met the primary endpoint, with a significantly greater proportion of patients achieving ASAS40ⁱ response at week 16 vs. placebo in the r-axSpA study (39.5% vs. 20.9%; treatment difference 18.6% [95% CI 7.6, 29.6]; p=0.001) and nr-axSpA study (34.5% vs. 17.8% treatment difference 16.7% [95% CI 5.7, 27.6]; p=0.003).ⁱⁱⁱ ASAS40 responses occurred early (from week 1) with filgotinib and continued to increase up to week 52.ⁱⁱⁱ

Despite the availability of multiple treatment options, nearly half of patients do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment, according to data from randomised controlled trials with biologic and targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).^iv Data from the Phase 3 OLINGUITO trial showed approximately 40-44% of patients receiving filgotinib achieved ASDAS inactive disease (ID) or low disease activity (LDA) at week 16, with the proportion of patients increasing to 58-61% at week 52; these trends were consistent irrespective of prior biologic DMARD treatment.^v

“People living with axSpA can suffer debilitating symptoms from a young age, and many fail to achieve sustained disease control," said Daniele D'Ambrosio, Chief Development Officer, Alfasigma. “Primary OLINGUITO data shared at EULAR 2026 showed sustained improvements in the signs and symptoms of axSpA with filgotinib, which is currently under review by European regulatory authorities as a potential new treatment option for adults living with this chronic and progressive disease.”

“Filgotinib delivered rapid improvements in axSpA symptoms, and reductions in bone erosion plus minimal or no progression of ankylosis observed over the 52-week study period indicated limited progression of structural damage. These encouraging findings help support the potential of filgotinib as an option for patients living with axSpA at all stages of the disease and with prior exposure and reduced response to existing treatments,” said Professor Xenofon Baraliakos, Head of Rheumatology at the Rheumazentrum Ruhrgebiet, Herne, Germany, Professor for Internal Medicine and Rheumatology at the Ruhr-University Bochum, Germany.

OLINGUITO data shared at EULAR 2026:

About OLINGUITO

OLINGUITO (NCT05785611) is a Phase 3 randomised, placebo-controlled, double-blind, parallel-group trial to evaluate the efficacy and safety of filgotinib in adult patients with active axSpA. The trial consists of two studies of patients with active axSpA who had an inadequate response to conventional or biological treatments. Study A included 258 patients with r-axSpA, while study B included 237 patients with non-radiographic axSpA (nr-axSpA). Patients in both studies were randomised (1:1) to receive treatment with oral filgotinib 200mg, or matching placebo, once daily for 16 weeks.

The primary endpoint for both studies was the proportion of patients who achieved an Assessment of SpondyloArthritis international Society 40% improvement (ASAS40) at week 16. Thereafter, patients without pre-specified risk factors entered an open-label treatment period in which they received filgotinib 200mg once daily up to week 52.

Patients from study A and study B who achieved sustained low disease activity or inactive disease during the open-label period were re-randomised (1:1) at week 52 to receive double-blind filgotinib 100mg or 200mg up to week 104. In patients above 65 years of age and those with increased risk factors for cardiovascular disease or malignancies, at week 16 in the case of achievement of disease control after treatment with 200mg once daily, the dose was reduced to 100mg once daily for up to week 104.

About axial spondyloarthritis

Axial spondyloarthritis (axSpA) is a chronic inflammatory condition that primarily affects the axial skeleton (spine and sacroiliac joints). While persistent back pain and spinal stiffness are common initial symptoms, the disease often also presents with peripheral manifestations such as enthesitis, arthritis, and dactylitis, as well as extra-musculoskeletal features including uveitis, inflammatory bowel disease and psoriasis.^vi

AxSpA comprises the whole spectrum of patients with and without radiographic sacroiliitis, that is, radiographic axSpA (r-axSpA; also known as ankylosing spondylitis, i.e., the damage caused by the disease can be seen on X-rays) and non-radiographic axSpA (nr-axSpA), respectively. AxSpA usually starts during the third decade of life; r-axSpA is more common in men than women, whereas there is an equal sex distribution among patients with nr-axSpA.^vi

About filgotinib

Filgotinib (marketed as Jyseleca^®) is currently approved by the relevant regulatory authorities in the European Union, United Kingdom, Japan, Taiwan, South Korea and Singapore. In Europe, United Kingdom, Japan, Taiwan, South Korea and Singapore, for the treatment of moderate to severe active rheumatoid arthritis in adults who have not responded adequately or cannot tolerate other DMARDs. Filgotinib is also approved in Europe, United Kingdom, Japan, Taiwan, South Korea and Singapore for the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Filgotinib 100 mg and 200 mg are registered in the above-mentioned territories.

The European Summary of Product Characteristics for filgotinib is available at www.ema.europa.eu. The United Kingdom Summary of Product Characteristics for filgotinib can be found at www.medicines.org.uk/emc. The interview from the Japanese Ministry of Health, Labor and Welfare is available at www.info.pmda.go.jp. The Taiwan Food and Drug Administration Assessment Report for filgotinib can be found at www.fda.gov.tw. The Korean Ministry of Food and Drug Safety report on filgotinib can be found here www.mfds.go.kr/eng/brd. The Singapore Summary of Product Characteristics for filgotinib can be found at www.hsa.gov.sg.

About Alfasigma

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group has products in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in several countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Spain and the United States and R&D labs in Italy).

Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission, to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.

For more information, please visit www.alfasigma.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Alfasigma. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development, or performance of the company and the estimates given here. Alfasigma assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

^* ASAS40: ≥40% improvement and an absolute improvement from baseline of ≥20 U (range 0–100) in ≥ three of the following four domains: back pain [10 cm visual analogue scale (VAS)], patient global assessment of disease activity (10 cm VAS), physical function (BASFI; range 0–100) and inflammation (mean score of items 5 and 6 of the BASDAI; both 10 cm VAS) without any worsening in the remaining domain. (Sieper J, et al. Ann Rheum Dis. 2009)
ⁱ OLINGUITO Clinical Trial (NCT05785611) Study Details | A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis | ClinicalTrials.gov. Accessed May 2026.
ⁱⁱ EudraCT 2022-501354-10-01. A Phase 3 program evaluating the effect of filgotinib in subjects with active axial spondyloarthritis. Accessed May 2026.
ⁱⁱⁱ Baraliakos X, et al. Filgotinib significantly improves disease activity in patients with active axial spondyloarthritis: Primary results from the Phase 3 OLINGUITO trial. [Abstract OP0234]. European Alliance of Associations for Rheumatology (EULAR) Congress 2026, London (3-6 June).
^iv Poddubnyy D, et al. The Assessment of SpondyloArthritis international Society (ASAS) consensus-based expert definition of difficult-to-manage, including treatment-refractory, axial spondyloarthritis. Ann Rheum Dis. 2025;84(4):538-546.
^v Van den Bosch F, et al. Efficacy of filgotinib on disease activity, including objective signs of inflammation across the full spectrum of axial spondyloarthritis: 52-week results from the Phase 3 OLINGUITO trial [Abstract AB1048]. European Alliance of Associations for Rheumatology (EULAR) Congress 2026, London (3-6 June).
^vi Navarro-Compán V, et al. Axial spondyloarthritis. Lancet. 2025;405:159–72.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260526373154/en/