GlaxoSmithKline and Human Genome Sciences initiate phase III trial of belimumab (Benlysta®) administered subcutaneously in subjects with systemic lupus erythematosus

Issued: London UK & Philadelphia US

Study to enrol over 800 adult patients with SLE - Will evaluate once-weekly subcutaneous injections of an investigational formulation of belimumab plus standard of care vs. placebo plus standard of care

GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that dosing has been initiated in BLISS-SC, a new Phase III trialto evaluate the efficacy, safety and tolerability of BENLYSTA®  (belimumab) administered subcutaneously (SC) once-weekly to autoantibody-positive adults with active systemic lupus erythematosus (SLE).  
“Initiation of this new trial investigating a subcutaneous formulation of BENLYSTA represents an important step in our ongoing clinical development programme,” said H. Thomas Watkins, President and Chief Executive Officer, Human Genome Sciences (HGS).   

About the Design of BLISS-SC

BLISS-SC is a Phase III, multi-centre, international, randomised, double-blind, placebo-controlled, 52-week study to investigate use of belimumab administered subcutaneously once-weekly in autoantibody-positive adult subjects with active SLE.  

Approximately 816 SLE subjects will be randomised to one of two arms, with a target of 544 subjects receiving belimumab 200 mg weekly plus standard of care (SOC) and 272 subjects receiving placebo plus SOC. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects will receive belimumab 200 mg SC weekly.  

The primary efficacy endpoint of BLISS-SC is response rate at week 52, as measured by the SLE Responder Index (SRI) defined as:

• A reduction from baseline of at least 4 points on the SELENA-SLEDAI; and
• No worsening (increase of

HGS Safe Harbor Statement

This announcement includes statements that are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include expectations regarding the Phase 3 trial and potential for BENLYSTA delivered by subcutaneous injection. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this announcement, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.