Alfasigma Reports Positive Phase 3 Results for Filgotinib in Axial Spondyloarthritis

Alfasigma Reports Positive Phase 3 Results for Filgotinib in Axial Spondyloarthritis

By, Admin 31 July 2025

Alfasigma S.p.A. has announced positive topline results from the OLINGUITO Phase 3 clinical trial of filgotinib, a JAK1 inhibitor, in patients with active axial spondyloarthritis (axSpA).

Key Highlights from the OLINGUITO Trial

  • Primary Endpoint Met: Filgotinib achieved ASAS40 response at Week 16 in both r-axSpA and nr-axSpA groups.
  • Consistent Safety Profile: No unexpected safety events reported, consistent with earlier trials.
  • Indication Expansion Planned: Based on these results, Alfasigma plans to submit for indication extension.

Quotes from Leadership and Investigators

Daniele D’Ambrosio, Chief Development Officer at Alfasigma:

“These results show filgotinib’s potential to address unmet needs in axSpA, where many patients don't respond adequately to current treatments.”

Professor Xenofon Baraliakos of Ruhr-University Bochum:

“This trial supports filgotinib’s role across the full axSpA spectrum—critical as treatment options remain limited.”

Understanding Axial Spondyloarthritis (axSpA)

  • Chronic, Inflammatory Disease: Primarily affects the spine and sacroiliac joints.
  • Early Onset: Often begins in the third decade of life.
  • Limited Treatment Response: Only 40-50% of patients show significant response; 10-20% reach remission within 24 weeks.

Trial Design Overview: OLINGUITO Phase 3

  • Trial ID: NCT05785611; Eudra CT 2022-501354-10-01
  • Design: Double-blind, multi-centre, parallel-group studies
  • Population:
    - Study A: 258 patients with radiographic axSpA (r-axSpA)
    - Study B: 237 patients with non-radiographic axSpA (nr-axSpA)
  • Randomization: 1:1 to receive filgotinib 200 mg or placebo for 16 weeks

Endpoints and Extension Design

  • Primary Endpoint: ASAS40 improvement at Week 16
  • Open-Label Period: Patients without risk factors continued filgotinib up to Week 52
  • Dose Adjustments:
    - At-risk patients shifted to 100 mg after Week 16
    - Dose could increase back to 200 mg in case of flares
  • Re-randomization at Week 52: Patients with disease control randomized to 100 mg or 200 mg up to Week 104
  • OLE Study: Eligible patients (post-Week 104) will enter a 2.5-year extension to assess long-term efficacy and safety

Previous Clinical Validation: The TORTUGA Trial

  • Trial ID: NCT03117270
  • Type: Phase 2, placebo-controlled
  • Findings: Confirmed efficacy and safety of filgotinib in r-axSpA

Current Regulatory Approvals of Filgotinib (Jyseleca)

  • Approved Markets:
    - EU, UK, Japan, Taiwan, South Korea, Singapore
  • Approved Indications:
    - Moderate to severe active rheumatoid arthritis (RA)
    - Moderate to severe active ulcerative colitis (UC)
  • Available Doses: 100 mg and 200 mg

AxSpA Disease Spectrum and Clinical Impact

  • Two Forms:
    - r-axSpA (radiographic): Structural damage visible on X-ray
    - nr-axSpA (non-radiographic): Symptoms present, but no visible structural damage
  • Associated Conditions:
    - Peripheral symptoms: Enthesitis, arthritis, dactylitis
    - Extra-skeletal: Uveitis, inflammatory bowel disease, psoriasis
  • Gender Distribution:
    - r-axSpA: More common in men
    - nr-axSpA: Equal prevalence among sexes

About Alfasigma

  • Headquarters: Bologna and Milan, Italy
  • Global Presence:
    - Operations in 100+ markets across Europe, the Americas, Asia, and Africa
    - Offices in Italy, US, Spain, Germany, Mexico, and China
  • Manufacturing Sites:
    - Italy: Pomezia, Alanno, Sermoneta, Trezzano Rosa
    - Spain: Tortosa
    - USA: Shreveport, Louisiana
  • R&D Labs: Located in Pomezia and Bergamo, Italy

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