Phase 2a trial begins for BT-063 for SLE treatment

Biotest, Inc. announced it has begun a phase 2a trial to test its monoclonal antibody BT-063 as a treatment for systemic lupus erythematosus and the first patient has begun treatment, according to a company press release.

The monoclonal antibody targets interleukin-10 (IL-10), which is believed to have a “crucial role in the development” of systemic lupus erythematosus (SLE), according to the release. Safety was evaluated in healthy volunteers during a completed phase 1 study. The phase 2a study has enrolled and begun treatment of its first patient with SLE and more patients will be enrolled from “several European countries,” according to the release. The primary goal of the study is to determine safety and tolerability and to obtain early data related to efficacy.

Parallel pharmacological investigations will also take place to better understand the mode of action observed with BT-063.

“This is a major milestone in the clinical development of BT-063. In this clinical study with the humanized anti-IL-10 antibody, we hope to confirm the results regarding indications of efficacy and tolerability that were obtained during a previous study,” Biotest Vice President of Corporate Clinical Research Andrea Wartenberg-Demand, MD, said in the release. “We hope these results will bring us one step further in the development of a new therapeutic option to treat patients suffering from this serious disease.”

Reference : http://www.biotest.com.