Sanofi and Regeneron presented the Phase 3 results for Dupixent (dupilumab) in patients with uncontrolled chronic obstructive pulmonary disease (COPD) at the American Thoracic Society (ATS) International Conference.
The BOREAS trial, which evaluated the use of Dupixent compared to placebo in patients with uncontrolled COPD and evidence of type 2 inflammation, achieved its primary and key secondary endpoints. The study included patients on maximal standard-of-care inhaled triple therapy. The results showed notable benefits of Dupixent:
Reduction in Exacerbations: Patients receiving Dupixent experienced a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks compared to placebo.
Improved Lung Function: Dupixent demonstrated significant improvements in lung function at 12 and 52 weeks. Patients experienced a 160 mL improvement from baseline at 12 weeks, with numerical improvements reported within two weeks and sustained through 52 weeks.
Enhanced Quality of Life: Dupixent significantly improved health-related quality of life (QoL) and respiratory symptom severity. Patients reported a 9.7-point improvement in QoL from baseline at 52 weeks compared to a 6.4-point improvement in the placebo group. Additionally, there was a 2.7-point reduction in respiratory symptom severity from baseline at 52 weeks.
In a pre-specified analysis of a subgroup with higher levels of fractional exhaled nitric oxide (FeNO), an airway biomarker of type 2 inflammation, Dupixent treatment resulted in a 38% reduction in exacerbations compared to placebo at 52 weeks. Lung function improvements were also observed in this subgroup, with a 232 mL improvement at 12 weeks compared to 108mL in patients on placebo and a sustained improvement of 247 mL at 52 weeks in Dupixent arm versus 120mL in patients on placebo.
The safety profile of Dupixent in COPD was consistent with its known safety profile in approved indications.
Bristol Myers Squibb (BMS) has presented results from its clinical trial evaluating the efficacy of the investigational LPA1 antagonist, BMS-986278, in reducing the rate of lung function decline among patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF).
The Phase 2 trial, conducted by BMS, aimed to assess the potential benefits of the LPA1 antagonist as a treatment option for IPF patients. The study involved a significant number of participants and utilized rigorous methodologies to ensure reliable and credible findings.
The trial's primary endpoint was the measurement of lung function decline over a specific period. BMS-986278, 60 mg, was administered twice daily over 26 weeks; the rate of decline in percent predicted forced vital capacity (ppFVC) was 62% versus placebo.
Further, BMS announced that BMS-986278 was well tolerated, with treatment rate discontinuation rates similar to the placebo.