Chiesi Farmaceutici has announced results from the Phase 3 TRIGGER and TRIMARAN studies of its CHF 5993 extrafine beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium (G) MDI for the treatment of uncontrolled asthma in patients who have had at least one exacerbation in the past year. CHF 5993, also known as Riarify, contains the same three drugs as Chiesi’s Trimbow, which was approved by the EMA in August 2017. Data from the two 52-week studies, which enrolled a total of 2,592 patients, were published in the Lancet.
The TRIMARAN study compared BDP/FF/G 100/6/10 μg to BDP/FF 100/6 μg, and TRIGGER compared BDP/FF/G 200/6/10 μg to BDP/FF 200/6 μg and BDP/FF 200/6 μg plus tiotropium 2.5 μg. Both studies enrolled adult patients with asthma that was not controlled sufficiently with ICS/LABA therapy. Improvement in pre-dose FEV1 at week 26 for BDP/FF/G vs BDP/FF was 57mL in TRIMARAN and 73mL in TRIGGER. The rate of reductions in moderate-to-severe exacerbations over 52 weeks was 15% in TRIMARAN and 12% in TRIGGER. In a pre-specified pooled analysis, BDP/FF/G also decreased the annualized rate of severe exacerbations versus BDP/FF by 23%, the rate of moderate exacerbations by 12%, and moderate plus severe exacerbations by 14%.
Chiesi Group Region Europe Head Alessandro Chiesi commented, “Today’s publication in The Lancet highlights Chiesi’s commitment to providing efficacious, well-tolerated and convenient treatment options for a disease that affects 8% of adults across Europe. We are proud to be supporting these innovative studies which provide us with key evidence on the benefits of single-inhaler triple therapy over other combination inhaler therapies. We look forward to continuing to showcase the benefits that our triple therapy in a single inhaler can bring to adult patients with asthma uncontrolled on ICS/LABA therapy.”
Read the Chiesi press release.
