Phase 1 Study of Experimental Systemic Sclerosis Treatment Bermekimab Begins

According to a recent press release from XBiotech, a Texas-based biotechnology company, patient dosing is now underway in a phase 1 clinical study of the Company’s investigational systemic sclerosis treatment, bermekimab.

About Systemic Sclerosis

Systemic sclerosis (SSc) is a rare autoimmune disorder characterized by idiopathic scarring in the skin and other organs, as well as by widespread vascular irregularities. Like in other autoimmune disorders, these symptoms of SSc are caused by improperly regulated immune activity that damages healthy cells as though they were hostile pathogens.

Excessive scarring in the form of localized buildups of collagen (a tough connective protein) can have significant and varied effects depending on location. In the skin it can cause toughening and thickening. In organs it eventually leads to significant dysfunction and potentially fatal complications.

Earliest symptoms tend to involve the extremities, possibly due to high concentrations of narrow minor blood vessels. Raynaud phenomenon, characterized by color changes in the fingers and toes, is a commonly reported early symptom. Eventually, scar tissue begins to build, toughening the skin. Finally, vital organs may be involved; the most frequently involved organs include the esophagus, kidneys, lungs, and heart.

Sometimes known as systemic scleroderma, SSc is highly rare — estimated to occur only 50 to 300 times in a sample of one million people. Certain therapies exist that can help SSc patients manage the worst effects of their symptoms, but there is no cure.

About Bermekimab

Bermekimab is an experimental monoclonal antibody that researchers hope will help SSc patients manage the severity of their condition. Monoclonal antibodies are antibodies derived from unique immune cells that are cloned from a particularly desirable “parent” cell. In this case, the immune cells are selected from individuals who have “natural immunity to certain diseases.”

In a 12-week randomized, double-blind, placebo-controlled study, participants in XBiotech’s study will receive a weekly injection of bermekimab or placebo. At the end of this roughly 3 month period, patients will have their conditions assessed based on a number of clinical and physiological factors. Those who would like to continue their treatment will have the option to do so in a supplementary open label phase of the study that will continue for another 12 weeks after initial data is collected.

Although the road to clinical approval is long, the number of effective treatments available for SSc is limited. Merely the effort to study SSc treatments in a clinical environment is encouraging news.


Even successful drug candidates take years to progress from phase 1 testing to market. How meaningful is an opportunity to participate in an early clinical trial like this? Share your thoughts with Patient Worthy!

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