Milestone Pharmaceuticals gets to advance its pivotal program of etripamil, its novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT), the company said in an quarter and half year financial update.
The company posted the second quarter of 2019 operating loss of $13.7 million compared to $3.6 million in 2018.
Research and development expense for the second quarter of 2019 was $10.5 million compared with $2.6 millionfor the prior year period.
Commercial expense for the second quarter of 2019 was $2.2 million compared with $0.4 million for the prior year period.
General and administrative expenses for the second quarter of 2019 were $1.6 million compared with $0.8 millionfor the prior year period.
“We are very encouraged by our most recent interaction with the FDA and remain well positioned for continued execution of our etripamil pivotal program in PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals.
“Following this interaction, we now look forward to beginning enrollment in our NODE-303 open-label global safety study before the end of the year. Execution of our pivotal Phase 3 NODE-301 trial is also tracking ahead of our initial projections, and upsizing of the trial will enable us to satisfy a European Medicines Agency (EMA) regulatory request, increase the study’s power and potentially strengthen valuable sub-population analyses and pharmacoeconomic assessments, all while remaining on schedule to report topline data in the first half of 2020. Etripamil has the potential to serve as the first-ever self-administered therapy for the rapid termination of episodes of PSVT wherever and whenever they occur, and our continued progress takes us steps closer to realizing this potential to help patients living with PSVT.”