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
