Anthera Pharmaceuticals recently announced that the last patient in the company’s Phase 3 clinical trial, evaluating blisibimod for the treatment of systemic lupus erythematosus, has received the the final dose.
The study will be completed and the data analyzed within the next two months, just in time for the upcoming American College of Rheumatology Annual Meeting, to be held in November, in Washington D.C.
Blisibimod acts by blocking BAFF, a B-cell activating factor crucial for various stages of B-cell development and life. The drug is a fusion between an antibody and a protein part capable of binding BAFF.
The study, called CHABLIS-SC1 (NCT01395745), enrolled 442 patients in 12 countries throughout Asia, Eastern Europe, and Latin America. All patients were on corticosteroid treatment in addition to standard treatment, and were considered to have more severe lupus. Patients were randomized to receive either 200 mg blisibimod or placebo; study staff and participants were blinded to the treatment designation of individual subjects. All patients continued using their standard medications during the trial.
The trial aims to show that blisibimod lowers the Systemic Lupus Erythematosus Responder Index, a commonly used tool to assess lupus disease activity, by six points at the end of the 52-week study. Other endpoints include a reduction in the number of lupus flares as well as reductions in the use of corticosteroid medications. If the secondary goals turn out positive, they may be used to show that blisibimod is better than current available therapies. The study is also evaluating side effects and treatment safety.
“We are very pleased that we have had our last patient dosed in this 52-week active dosing study,” said Dr. James Pennington, Anthera’s interim chief medical officer, in a news release.
An earlier Phase 2 trial (NCT01162681), intended to find the drug’s optimal dose range, also showed blisibimod was both safe and effective, which prompted the continuation of Phase 3 studies. Anthera also recently started a second Phase 3 trial, called CHABLIS 7.5 (NCT02514967), to specifically focus on patients who continue to have disease activity despite corticosteroid use.