Phase 2 Study of Bermekimab in Treating Scleroderma Enrolls 1st Patient

The first person has been enrolled in a clinical trial evaluating the investigational therapy bermekimab in adults with scleroderma, XBiotech, the developer of bermekimab, announced.

Although the cause of scleroderma is unknown, the disease is thought to be at least partly driven by abnormally high levels of an inflammatory signaling molecule called interleukin-1 alpha (IL-1⍺). IL-1⍺ is a sort of master regulator, as it triggers the release of other signaling molecules that drive inflammation.

In people with scleroderma, IL-1⍺ levels have been shown to be unusually high, and the production of this molecule in fibroblasts — a type of skin cell that behaves abnormally in scleroderma — makes these cells act in ways they do in the disease. As such, it’s suggested that blocking IL-1⍺ signaling may be a viable way of treating scleroderma.

Bermekimab is an antibody designed to specifically bind to IL-1⍺, neutralizing its ability to send inflammatory signals. The potential therapy is administered by subcutaneous (under-the-skin) injection.

The Phase 2 proof-of-concept trial (NCT04045743), sponsored by the Hellenic Institute for the Study of Sepsis, in Greece, plans to enroll 20 adults with scleroderma.

Participants will be randomized to treatment with either bermekimab (400 mg) or a placebo, given once a week for the first 12 weeks of the study. Those who complete this part will have the option of entering an open-label treatment period (in which all get the active treatment, with no placebo involved) for another 12 weeks (weeks 13–24).

The study’s primary endpoint (goal) is changes in scleroderma severity, as assessed by a combination of disease-related measurements, at 12 weeks (after the placebo-controlled phase).

“We have long suspected a role for IL-1⍺ in the pathogenesis of systemic sclerosis. There are thus strong fundamental principles behind our use of bermekimab in treating the disease,” Evangelos Giamarellos-Bourboulis, MD, PhD, a professor at Attikon University Hospital in Greece, and principle investigator of the study, said in a press release.

“We hope that this study will finally lead to an effective treatment approach for patients with systemic sclerosis,” Giamarellos-Bourboulis added.

For more information about the trial and how to participate, please visit this link. The study is enrolling at two sites in Greece, and is estimated to conclude in July 2021.