The company announced the first patient was enrolled in a clinical study in adults with systemic sclerosis.
XBiotech (NASDAQ:XBIT) has announced it has dosed the first patient in its clinical study evaluating bermekimab therapy in adults with systemic sclerosis (SSc).
As quoted in the press release:
The randomized double-blind, placebo-controlled trial will evaluate efficacy of weekly bermekimab monotherapy versus placebo. The primary endpoint of the study will be measured at 12 weeks, and will assess SSc disease severity using a combination of rheumatological, clinical, and physiological measures. The study will randomize patients 1:1 to receive either weekly subcutaneous injections of bermekimab or placebo. The study will also include an open label weekly bermekimab treatment regimen during weeks 13-24, where patients will continue to be evaluated using the same endpoints.
SSc is characterized by systemic inflammation that results in injury to blood vessels, and fibrosis of the skin and internal organs1. Skin lesions can be severe, resulting in disfiguration and debilitating pain. In addition, patients suffering from SSc have substantially reduced life expectancy due to the fibrosis that occurs in vital organs and chronic inflammation of the blood vessels2.