Ji Xing Pharma Announces Positive Phase 3 Results of Etripamil in China

On September 6, 2024, Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company dedicated to developing innovative cardiovascular treatments, announced that their licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a significant trial conducted in China. This multi-center, randomized, double-blind, placebo-controlled study examined the efficacy and safety of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT). The study emulated the design of the RAPID Phase 3 Study of etripamil in PSVT previously conducted by Milestone in North America and Europe.

The Phase 3 study (JX02002) involved 500 patients and achieved its primary endpoint. Kaplan Meier analysis revealed that a significantly higher proportion of patients who self-administered etripamil successfully converted from PSVT to sinus rhythm within 30 minutes compared to those who received a placebo (40.5% vs. 15.9%; hazard ratio [HR] = 3.00; 95% CI 1.58-5.71; p<0.001). Additionally, the study demonstrated statistically significant results (p<0.05) for secondary endpoints, showing the conversion of PSVT to sinus rhythm at 10, 15, 45, and 60 minutes post-administration.

Overall, Ji Xing reported that treatment-emergent adverse events were comparable across both treatment groups, with no serious adverse events related to etripamil. The safety and tolerability findings from the JX02002 trial aligned with previous clinical studies. This trial further extended the global development program of etripamil, encompassing over 2,000 patients treated with the drug.

Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, commended Ji Xing and the clinical investigators for the successful completion of the Phase 3 study. He expressed pride in the partnership's efforts to advance etripamil toward regulatory approval in China, potentially benefiting millions of PSVT patients.

Following the licensing agreement announced on May 21, 2021, Milestone granted Ji Xing the exclusive rights to develop and commercialize etripamil in Greater China, contingent on regulatory approval. As part of this agreement, Milestone received an upfront payment of $15 million, along with a $5 million equity investment by RTW Investments, LP. Milestone is also eligible for up to $107.5 million in milestone payments and royalties based on future sales of etripamil in Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Milestone supplies etripamil and the necessary delivery devices, while Ji Xing handles development and commercialization costs in Greater China.

PSVT, a type of arrhythmia characterized by episodes of rapid heartbeats often exceeding 150 to 200 beats per minute, affects an estimated two million people in the United States. These episodes can cause severe palpitations, shortness of breath, chest discomfort, dizziness, and distress, significantly impacting patients' daily lives and causing anxiety due to their unpredictable nature. Current treatment options are often inadequate, requiring patients to visit emergency departments or undergo invasive procedures like cardiac ablation.

Etripamil, Milestone's lead investigational product, is a novel calcium channel blocker nasal spray under development for treating frequent symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR). Designed for self-administration, this treatment aims to provide a rapid response without the need for immediate medical intervention. If approved, etripamil would offer a new on-demand care option, empowering patients to manage their condition actively. CARDAMYST™ (etripamil) nasal spray, the brand name for etripamil, is backed by a comprehensive clinical trial program, including a completed Phase 3 study for PSVT and a Phase 2 trial for AFib-RVR.

Milestone Pharmaceuticals Inc. focuses on developing and commercializing innovative cardiovascular treatments to enhance the quality of life for individuals with complex heart conditions. Their commitment to understanding patient needs has driven the development of new therapeutic approaches, enabling patients to take an active role in managing their care. Etripamil represents a significant advancement in this mission, offering a potentially transformative treatment option for PSVT and AFib-RVR patients.

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