Screening ongoing in Phase 2 trial of sonelokimab nanobody for axSpA
S-OLARIS testing if injection therapy reduces inflammation in spine, joints
Screening is ongoing for adults with active axial spondyloarthritis or axSpA, including ankylosing spondylitis, for a Phase 2 clinical trial in Germany that’s testing sonelokimab — a nanobody in the pipeline of Moonlake Immunotherapeutics for inflammatory diseases of the skin and joints.
The goal of the open-label study, called S-OLARIS (EudraCT 2024-513498-36), is to test how well sonelokimab can reduce inflammation in the spine and sacroiliac joints, which connect the spine to the pelvis. The trial aims to enroll about 25 patients, all of whom will receive a dose of sonelokimab 60 mg as an injection under the skin (subcutaneous). Top-line data are expected in early 2026.
With the launch of S-OLARIS and two other new trials — one for adolescents with hidradenitis suppurativa, which causes painful lumps where the skin rubs together, and another involving adults with palmoplantar pustulosis, in which fluid-filled blisters form on the palms of the hands and soles of the feet — the clinical program for sonelokimab now comprises a total of five indications.
“The start of three new trials across three new dermatology and rheumatology indications underscores Moonlake’s remarkable and rapid progress in independently realizing our ambitious plans,” Jorge Santos da Silva, PhD, Moonlake’s co-founder and CEO, said in a company press release.
According to Kristian Reich, MD, PhD, Moonlake’s chief scientific officer and the other co-founder, these are “all diseases characterized by activation of the IL-17 and IL-17F pathway in difficult-to-reach tissues” in the body.
“We are pioneering a paradigm shift in innovative trial design, which has given us the agility to rapidly execute these new clinical trials,” Reich said.
Seeking treatments to modify underlying disease processes in axSpA
IL-17A and IL-17F are key drivers of inflammation in many diseases of the skin and joints, including hidradenitis suppurativa and psoriatic arthritis, the lead indications for sonelokimab. By blocking IL-17A and IL-17F in hard-to-reach tissues, sonelokimab is expected to reduce inflammation and ease symptoms.
In the S-OLARIS trial, the researchers will watch for changes in inflammation in response to sonelokimab over 12 weeks, or about three months. PET scans, or positron emission tomography, will be used in combination with MRI to measure how much 18F-NaF is taken up by the spine and sacroiliac joints. 18F-NaF is a marker of bone metabolism.
Xenofon Baraliakos, MD, PhD, head of rheumatology at the Rheumazentrum Ruhrgebiet in northwestern Germany, where the S-OLARIS trial is taking place, said the trial is marking new ground.
“Integrating cutting-edge imaging techniques like MRI-PET with clinical outcomes, as being used in the S-OLARIS trial, offers a promising path forward,” Baraliakos said.
I am excited to see such a promising innovation like nanobodies, and specifically sonelokimab, being developed for axSpA. Our goal must be to develop more effective treatments that can improve long-term outcomes, reduce disease progression, and enhance the quality of life for all axSpA patients.
Eligible participants must have had back pain for at least three months, with symptoms starting before the age of 45, according to clinicaltrials.eu. Participants also must show signs of the disease on an MRI or test positive for C-reactive protein, a blood marker of inflammation. Patients also may have a diagnosis of ankylosing spondylitis with X-ray evidence of damage to the joints.
axSpA, a type of arthritis, primarily causes inflammation in the spine and sacroiliac joints. In radiographic axSpA, or ankylosing spondylitis, damage caused by inflammation can be seen on an X-ray. Over time, such damage can lead to back pain and stiffness, often beginning in early adulthood.
Despite advances, many patients still do not respond adequately to available treatments, according to the researchers.
“We need to continue to push the boundaries and explore novel approaches that can address not only inflammation across several domains but potentially modify the underlying disease processes,” Baraliakos said.
Sonelokimab is a nanobody, or a small antibody fragment, designed to block two-molecule compounds formed by pairs of IL-17A and/or IL-17F, called dimers. It uses two parts to bind these dimers and a third one to bind to albumin, an abundant protein that accumulates in inflamed tissues, helping the therapy reach the areas where it is needed most.
“I am excited to see such a promising innovation like nanobodies, and specifically sonelokimab, being developed for axSpA. Our goal must be to develop more effective treatments that can improve long-term outcomes, reduce disease progression, and enhance the quality of life for all axSpA patients,” Baraliakos said.
