Milestone Pharmaceuticals receives FDA clearance of MSP-2017 phase 2 IND


Milestone Pharmaceuticals has received clearance of its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to conduct a phase 2 study of MSP-2017 for the treatment of acute episodes of paroxysmal supraventricular tachycardia (PSVT). The trial is expected to begin patient enrolment in early 2015.

“The positive pharmacokinetic and pharmacodynamic results from our Australian phase 1 study suggest to us that MSP-2017 may show efficacy in termination of acute episodes of atrial tachycardia in patients with PSVT. We expect to initiate a phase 2 study with MSP-2017 by early 2015,” stated Philippe Douville, chief executive officer of Milestone.

The trial design cleared by FDA is a multiple arm phase 2, multicentre, placebo-controlled study of intranasal administration of MSP-2017 for the conversion of PSVT to sinus rhythm. The primary objective of this study will be to demonstrate the superiority of at least one dose of intranasal MSP-2017 over placebo in terminating PSVT induced in an electrophysiology laboratory.

MSP-2017 is a novel and potent short-acting calcium channel antagonist for the treatment of PSVT, a potentially debilitating cardiac arrhythmia. MSP-2017 has successfully completed phase 1 studies and is scheduled to start phase 2 in Q1 2015. The product is being developed as a patient self-administered nasal spray to terminate PSVT episodes at-home. MSP-2017 has a rapid onset and reaches pharmacologically relevant plasma levels within five minutes of administration. MSP-2017 is designed to be short-acting, allowing it to be metabolised quickly after resolution of the PSVT episode. MSP-2017 will allow patients to terminate their PSVT episodes at home and avoid ER visits.

MSP-2017 is intended to address a significant unmet medical need due to the lack of convenient, rapid, safe and effective self-administered products for the treatment of PSVT episodes in the home setting.