Milestone Pharmaceuticals said that it has initiated a Phase 3 clinical study of etripamil, an intranasal calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT). Results from a Phase 2 study of etripamil were announced in May 2017, and in August of that year, the company said that it had raised $55 million for Phase 3 development.
The Phase 3 study is expected to enroll up to 500 adult PSVT patients at US and Canadian cardiology centers. Patients will receive a test dose of etripamil in the cardiologist’s office and then will get either a 70 mg dose of etripamil or placebo for home use during a PSVT episode. The primary endpoint of the study is time to conversion of PSVT to sinus rhythm after the patient uses the drug. Patients will put on a wireless cardiac monitor during the event to record their heart rhythm.
Investigator Bruce Stambler of the Piedmont Heart Institute said, “The design of the NODE-301 study of etripamil will allow us to obtain more clinical evidence of the benefits of this potential treatment for PSVT in an outpatient, real-world setting,. PSVT is an unpredictable disorder and the potential for a fast-acting therapy to resolve the symptoms of PSVT wherever the episodes occur could significantly reduce the burden this condition puts on patients and the healthcare system.”
Milestone Chief Medical Officer Francis Plat said, “The initiation of the NODE-301 study is an example of our ongoing commitment to improve the lives of patients with PSVT. Etripamil, if approved by regulatory authorities, could empower patients to take control of this anxiety-producing arrhythmia without being reliant on chronic medications or trips to an acute-care facility for treatment.”
Read the Milestone Pharmaceuticals press release.
