Human Genome Sciences, Inc (HGSI)

[PETERDENIEL2003]

HGSI- GSK PIPELINE: INITIAL RESULTS OF PHASE 3 TRIALS OF ALBIGLUTIDE FOR TYPE 2 DIABETES EXPECTED MID-2012; ENROLLMENT COMPLETED IN SECOND PHASE 3 TRIAL OF DARAPLADIB FOR CARDIOVASCULAR DISEASE

GSK’s Phase 3 program to evaluate the long-term efficacy, safety and tolerability of albiglutide as monotherapy and add-on therapy for patients with type 2 diabetes mellitus continues to move forward. GSK announced topline results of the first of eight Phase 3 trials in November 2011. The study, known as Harmony 7, was designed to compare once-weekly albiglutide to once-a-day liraglutide. Results showed a reduction in HbA1c from baseline of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. Although the pre-specified margin of non-inferiority to liraglutide was not met, albiglutide did show a statistically significant reduction in HbA1c from baseline (p<0.001). The most common adverse events observed during this study were nausea (9.9% for abiglutide versus 29.2% for liraglutide) and vomiting (5%for abiglutide versus 9.3% for liraglutide).

GSK’s conclusion after review of the data is that the data support continued progress toward registration as a possible once-weekly treatment for type 2 diabetes. GSK expects initial results from the remaining studies over the course of the next several months, and has stated that it expects to provide an update on albiglutide once a more complete view of the data is available in mid-2012

http://www.hgsi.com/latest/human-genome-sciences-reports-progress-with-commercialization-of-benlysta-and-announces-2012-goals-at-jpmorgan-healthcare-confe.html

http://www.gsk-clinicalstudyregister.com/protocol_comp_list.jsp?compound=Darapladib