An independent Data Safety Monitoring Board (DSMB) established by Biotest has recommended the company begin part 2 of its Phase 2a clinical study assessing BT-063, a monoclonal antibody for the treatment of systemic lupus erythematosus (SLE). The DSMB recommendation follows positive interim results.
Study 990 (NCT02554019) is a Phase 2 proof-of-concept clinical trial evaluating the safety and effectiveness of repeated intravenous infusions of 50 mg BT-063 in 36 patients with SLE, compared to patients receiving a placebo in addition to their standard therapies.
The trial, being conducted in several European centers, is divided into two parts; each part will enroll 18 subjects. Participants will be randomly assigned to receive BT-063 or a placebo eight times over 12 weeks, and will be followed for four months after their last dose.
As per trial protocol, after part 1, an interim analysis was performed to decide on the trial continuation, as well as the best dose of BT-063 for part 2.
BT-063 is a humanized monoclonal antibody which selectively neutralizes human interleukin-10 (IL-10), involved in processes that lead to the differentiation and persistence of pathogenic B-cells in patients with SLE. The safety of BT-063 has already been evaluated in a Phase 1 clinical trial in healthy volunteers.
The DSMB considered there were no safety issues in part 1, and therefore has recommended Biotest continue with part 2 of the trial. Until part 2 has been completed, no other results will be reported to keep the study blinded.
“With BT-063, Biotest pursues a completely new therapeutic approach to treat SLE patients. I am very impressed by the large range of mechanistic and pharmacological investigations conducted in parallel to the clinical study No. 990,” Dr. Ronald van Vollenhoven, director of the Amsterdam Rheumatology and Immunology Center (ARC), said in a recent press release.
The trial’s primary endpoints include the assessment of treatment-related adverse events and changes in vital signs, electrocardiogram (ECG), safety laboratory parameters, and potential development of anti-drug antibodies against BT-063.
Secondary endpoints include the improvement of joints and skin (defined as 50 percent improvement of swollen/tender joints and 50 percent improvement in CLASI activity score, respectively), and the percent changes in SLE disease activity as measured by SLEDAI-2K score. A pharmacological evaluation will be performed in parallel to the clinical trial to obtain a more detailed understanding of BT-063’s mechanism of action.
The Data Safety Monitoring Board was established by Biotest as part of the company’s compliance with good clinical practice guidelines. It includes independent medical experts and a statistician who will regularly monitor patient safety and conduct interim analyses of trial results.