Phase 3 study for people with painful, highly inflammatory condition initiated by Galapagos
The company said the first patient was randomized in the study called Olinguito of the filgotinib. Topline results are expected in the second half of 2025.
In Galapagos' phase 2 Torutga study, 200mg of the drug achieved greater improvements in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12, the primary endpoint, and had an encouraging safety profile in patients with active radiographic-AxSpA who had not responded to conventional treatment.
Xenofon Baraliakos is professor of internal medicine and rheumatology at Ruhr-University Bochum, Germany and coordinating investigator of the study.
He said: “Axial spondyloarthritis is a chronic, painful, highly invalidating inflammatory condition that can profoundly impact patients’ quality of life.
“There is a high unmet need for effective oral treatment options for this condition. I am pleased that the first trial sites have been initiated and look forward to continuing to work with Galapagos and with the other study sites to rapidly enroll patients in this pivotal trial.”
Significant disease burden
The Olinguito global phase 3 program consists of two randomized, placebo-controlled, double-blind, multi-center, parallel-group studies. The objectives of the studies are to investigate the efficacy and safety of orally administered drug for 16 weeks in 476 patients with active r-AxSpA (Study A) and non-radiographic-AxSpA (Study B) who have had an inadequate response to conventional or biological treatment.
Each study will enroll approximately 238 patients who are randomized 1:1 to receive filgotinib 200mg or placebo once-daily.
“Patients with AxSpA face a significant disease burden and given the limited available therapies, there remains a high unmet medical need for effective oral treatment options,” said Daniele D’Ambrosio, therapeutic area head, immunology, at Galapagos.
“Filgotinib has demonstrated a consistent efficacy and safety profile across a range of patient populations, and inflammatory conditions and has the potential to address the needs of patients living with AxSpA. We look forward to advancing the OLINGUITO program and to working collaboratively with our clinical partners.”
AxSpA, also known as ankylosing spondylitis is a chronic inflammatory disease that involves primarily the sacroiliac joints (SIJs) and the spine, and is characterized by pain, stiffness and fatigue often leading to functional impairment.
The researchers found that are two distinct clinical ways that AxSpA can show up in the human body -radiographic and non-radiographic. In patients with radiographic r-AxSpA, the disease is confirmed by the presence of damage in the SIJ on x-Ray. In nr-AxSpA, this sign is absent, and presence of disease is confirmed by MRI or genetic features.
Inflammatory back pain
They say first symptoms indicative of AxSpA tend to develop in young adults, aged 20 to 30 years. Typical early symptoms of the disease include inflammatory back pain, which is characterized by nocturnal pain and prolonged morning stiffness of the (lower) back with impaired physical function.
Those involved in the studies say that any patients present with articular (arthritis, dactylitis) and extra-articular (for example inflammatory bowel disease, uveitis, psoriasis) symptoms associated with AxSpA. Studies report the prevalence of AxSpA ranges from nine to 30 per 10,000 in the general population, depending on geographic area, study population or data source, case definition, and ascertainment methods.
Filgotinib is marketed as Jyseleca in Europe and Japan for the treatment of adults with moderate to severe active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs.