Milestone’s Etripamil Nasal Spray Advances Towards Regulatory Filing in China for PSVT Treatment

Clinical Trial Success:
Ji Xing Pharmaceuticals Ltd, a licensing partner of Milestone Pharmaceuticals, has announced positive topline results from a Phase 3 study of etripamil nasal spray for treating paroxysmal supraventricular tachycardia (PSVT) in China.

Study Design and Outcomes:
The multi-center, randomized, double-blind, placebo-controlled study (JX02002) involved 500 participants and demonstrated a statistically significant higher rate of patients converting from PSVT to sinus rhythm within 30 minutes compared to those receiving a placebo.

Safety and Tolerability:
The study showed similar incidence rates of treatment-emergent adverse events across both treatment groups, with no serious adverse events linked to etripamil reported.

Global Development Initiative:
This study broadens the etripamil global development initiative to include over 2,000 distinct patients who have received etripamil, further supporting its potential for regulatory approval and commercialization in China.

Licensing Agreement:
Milestone Pharmaceuticals has provided Ji Xing with an exclusive license to develop and commercialize etripamil for PSVT patients in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan, with potential milestone payments and royalties from future sales.

Regulatory Filing:
The positive results from the Phase 3 study bring etripamil nasal spray closer to regulatory filing in China, potentially offering a new treatment option for millions of individuals affected by PSVT.