Milestone Pharmaceuticals has reported that the Phase 3 NODE-301 trial of its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) has missed its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the five hours post dose. The NODE-301 trial, which was initiated in August 2018, enrolled 431 patients who used either a 70 mg dose of etripamil or a placebo nasal spray during a PVST episode.
According to the company, etripamil outperformed the placebo at earlier points in time post dose, with 61% of patients using etripamil converted at 45 minutes post dose compared to 45% of patients using the placebo. Etripamil also produced statistically significant improvements in patient reported treatment satisfaction compared to placebo and only 15% of patients who used etripamil sought rescue medical interventions compared to 27% for those who used the placebo.
Milestone President and CEO Joseph Oliveto commented, “Efficacy signals across the earlier time points in NODE-301, in both primary and secondary endpoints, correlate directly with our understanding of the drug’s known pharmacologic activity. We are also encouraged to see very good safety and tolerability across the broad population enrolled in this study. That said, outcomes after 100 minutes, which were affected by a very small number of placebo patients remaining in the study at that time, suggest that the design and analysis plan used in NODE-301 negatively impacted the study’s outcome. The overall results of the study reinforce our understanding of the promising profile of etripamil and meaningfully inform us how best to prove its efficacy moving forward.”
Oliveto continued, “We will continue to execute as prudently possible on the ongoing NODE studies, including NODE-301B, and look forward to reviewing these data with regulators. The ongoing pandemic highlights the need for, and strengthens our commitment to, home use therapies.”
The company said that it plans to meet with regulators to discuss the Phase 3 program, which also includes the ongoing NODE-301B, which includes patients who had been randomized in NODE-301 but who did not have an SVT event before NODE-301 was completed. The NODE-302 safety study began in December 2018, and in October 2019, Milestone announced that it had initiated the NODE-303 open-label safety study of etripamil nasal spray for PSVT. Both of those studies are still recruiting.
Read the Milestone Pharmaceuticals press release.
