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.”

Exonate has announced plans to initiate a phase 2b clinical trial of its lead candidate EXN407, a topical SRPK1 inhibitor, for non-proliferative diabetic retinopathy (NPDR). The CLEAR-DE trial is scheduled to begin in early 2026.

The study will evaluate efficacy, dosing and safety in 140 NPDR patients across sites in Australia, the Middle East and China.

The decision follows positive results from Exonate’s phase 1b/2a trial in March 2024. EXN407 met its safety and tolerability endpoints, with no drug-related serious adverse events and high patient compliance.

Exploratory efficacy signals showed reduced vascular leakage, a key driver of diabetic retinopathy progression.

Diabetic retinopathy affects around one-third of the global diabetic population.  NPDR, its early stage, can lead to vision-threatening complications if untreated.

Current treatments rely on monthly intraocular injections, typically delayed until symptoms worsen. This limits early intervention and can result in irreversible damage.

EXN407 is a first-in-class, twice-daily eye drop formulation designed to inhibit SRPK1. It modulates VEGF expression via alternative mRNA splicing, targeting pro-angiogenic isoforms responsible for abnormal retinal blood vessel growth.

Dr Catherine Beech, Chief Executive Officer of Exonate, said: “The phase Ib/IIa data demonstrated the clear potential of EXN407 as a non-invasive treatment for diabetic eye disease.”