GlaxoSmithKline and Theravance have announced the commencement of a Phase 3 study of a triple combination inhaled therapy delivered using the Ellipta DPI for the treament of COPD. The triple therapy combines fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI).
The 52-week study will involve approximately 10,000 patients in 38 countries who will receive either FF/UMEC/VI, FF/VI (Relvar/Breo Ellipta), or UMEC/VI (Anoro Ellipta). Primary endpoints are the rate of moderate and severe exacerbations over the course of the year for the triple therapy compared to FF/VI and for the triple therapy compared to UMEC/VI.
GSK Respiratory Therapy Area Unit R&D Head Dave Allen said,“When developing our respiratory portfolio we recognized the need to offer a range of molecules that could be co-formulated in different combinations to meet the needs of individual patients. We know from the scientific literature and prescribing data that there are already COPD patients who receive three medicines in different inhalers, for whom a once-daily treatment in a single ‘closed’ device could be valuable. The IMPACT study will be important in advancing our understanding of how the combination of FF/UMEC/VI could be used in this setting when compared to dual combination therapy options.”
Theravance CEO Rick E. Winningham added, “The start of the IMPACT study marks a significant milestone in our development program with GSK and we are excited about the potential opportunity for a triple combination treatment approach. This phase 3 program has the potential to demonstrate the safety and efficacy profile of a new and important therapy that could deliver additional benefits and convenience to the growing number of adults living with COPD worldwide.”
Read the GSK/Theravance press release.
