US-based biopharmaceutical company Eiger has dosed the first patient in the Phase II Ultra trial of ubenimex to treat secondary lymphedema of the lower limbs.
Ubenimex is a well-characterised, oral, small-molecule that inhibits leukotriene A4 hydrolase (LTA4H), an enzyme instrumental in the formation of the pro-inflammatory mediator LTB4, which causes tissue inflammation and impaired lymphatic function.
The multi-centre, randomised, double-blind, placebo-controlled Phase II trial is planning to involve about 40 patients with secondary lymphedema of the lower limbs and are undergoing physical therapies.
During the trial, patients will be randomised on a 1:1 ratio and administered with ubenimex or matching placebo orally for a duration of 24 weeks.
Eiger chief medical officer Joanne Quan said: "Lymphedema can have long-lasting deleterious effects and significantly impact quality of life.
“There is no FDA approved pharmacologic treatment. Patients must currently rely on physical therapies such as manual lymph drainage and compression garments for relief.
"The ULTRA study is designed to explore a novel approach to the treatment of secondary lymphedema by blocking the production of LTB4.
“This approach has the potential to lessen the effects of this serious and debilitating disease and provide a convenient treatment option for patients."
The trial will examine the clinical, biomarker, histologic and patient-reported results following the administration of ubenimex.
Ubenimex has pharmacologically inhibited LTB4, which resulted to lymphatic repair and reversed lymphedema disease in animals.