Xoma has initiated patient dosing in its Phase II proof-of-concept study, designed to investigate the efficacy and safety of Gevokizumab (XOMA 052), an inhibitor of interleukin-1 beta, used to treat inflammatory lesions seen in moderate to severe acne vulgaris.
Gevokizumab is a potent monoclonal antibody that inhibits the activation of interleukin-1 beta, a pro-inflammatory cytokine, thereby modulating the cellular signaling events that produce inflammation.
The Phase II study will randomise around 170 patients to receive one of two dose levels of gevokizumab, or a placebo, administered subcutaneously over a three-month period.
In the proof-of-concept study, the primary efficacy endpoint is the mean absolute change from baseline in inflammatory facial lesion count after three months of therapy.
Xoma Interim CEO John Varian said the study is intended to expand the importance of gevokizumab, the company’s lead clinical asset, by demonstrating its potential in diseases characterized by interleukin-1 beta over-expression.
”This is the first in a series of clinical studies that we plan to conduct in separate indications over the next 12-18 months," Varian added.
"Upon completion of this series of proof-of-concept studies, we believe we will have sufficient evidence to initiate a further development program in at least one of these indications."
The drug candidate has been studied in nearly 500 patients, with approximately 300 patients on treatment for six months, and was found to reduce intraocular inflammation and improve visual acuity or other ophthalmic measures after a single treatment following discontinuation of immunosuppressive drugs.
Acne is characterised by the presence of Proprionumbacterium acne, which promotes the production of proinflammatory substances including interleukin-1 beta in experimental models of the disease.
The company also plans to begin a Phase III clinical development programme of gevokizumab in non-infectious uveitis affecting the intermediate or posterior segments of the eye.