Ji Xing Pharmaceuticals Reports Breakthrough Phase 3 Findings

Ji Xing Pharmaceuticals' Etripamil Study Yields Promising Results

In a significant advancement in cardiovascular medicine, Milestone Pharmaceuticals Inc. has applauded its partner, Ji Xing Pharmaceuticals Ltd, for publicly sharing positive topline results from a Phase 3 clinical trial concerning etripamil nasal spray. This study, conducted across multiple centers in China, focused on assessing the safety and efficiency of etripamil for treating paroxysmal supraventricular tachycardia (PSVT). The results align closely with previous studies conducted by Milestone in North America and Europe.

Phase 3 Trial Success

The Phase 3 trial, known as JX02002, included 500 patients and met its primary endpoint. The analysis, conducted using the Kaplan Meier method, illustrated that a statistically significant greater proportion of patients utilizing etripamil successfully converted from PSVT to normal sinus rhythm within 30 minutes compared to those receiving a placebo (40.5% vs. 15.9%, respectively). This effectiveness was supported by additional statistically significant findings at multiple timepoints after self-administration of the treatment.

Safety Profile and Implications

Ji Xing reported that both treatment groups experienced comparable rates of treatment-emergent adverse events with no serious adverse effects linked to etripamil. These safety and tolerability results correspond well with findings from earlier trials, reinforcing a growing body of data regarding etripamil's reliability. This pivotal study contributes positively to the global development program, which has included over 2,000 unique patients treated with etripamil, enhancing its profile in the cardiovascular therapeutics landscape.

Joseph Oliveto's Statement

Joseph Oliveto, the President and CEO of Milestone Pharmaceuticals, expressed his enthusiasm regarding Ji Xing's successful completion of this extensive Phase 3 trial. “We are proud to partner with Ji Xing as they move etripamil closer to receiving regulatory approval in China, offering hope for millions who face challenges related to PSVT,” he stated.

Licensing Agreement Details

As part of a strategic licensing agreement established on May 21, 2021, Milestone has granted Ji Xing exclusive rights to develop and potentially commercialize etripamil for PSVT in Greater China. This agreement provided Milestone with an upfront cash payment of $15 million, coupled with a $5 million investment by RTW Investments, LP. Additionally, Milestone stands to gain up to $107.5 million in milestone payments and future royalties dependent on etripamil’s sales within Greater China.

Understanding PSVT and Its Impact

Approximately two million individuals in the United States are diagnosed with PSVT, a condition leading to rapid heartbeats that can exceed 150 to 200 beats per minute, occurring unexpectedly and lasting for extended periods. Symptoms often include debilitating palpitations, dizziness, or shortness of breath, greatly affecting the daily lives and mental well-being of those impacted. Many patients are left frustrated by a lack of effective treatment options, often resorting to emergency departments for management.

Introducing Etripamil's Mechanism

Etripamil, Milestone's flagship investigational product, functions as a nasal spray delivering a novel calcium channel blocker designed for the management of rapid heart rhythm disturbances like PSVT and atrial fibrillation with rapid ventricular rates. The self-administered nature of etripamil underscores its appeal as a convenient, on-the-spot treatment, empowering patients with greater control over their symptoms. With extensive clinical trials backing its efficacy, etripamil is poised to be a game-changer in patient self-management in the future.

About Milestone Pharmaceuticals

Milestone Pharmaceuticals Inc., trading on Nasdaq under the ticker MIST, is dedicated to innovating cardiovascular solutions that significantly enhance the lives of individuals facing serious heart conditions. With a dedicated focus on addressing unmet patient needs, Milestone continues to pioneer new therapeutic pathways aimed at providing patients with a more active role in managing their health.

Frequently Asked Questions

What were the primary results of the JX02002 Phase 3 trial?

The trial demonstrated that patients self-administering etripamil had a significantly higher conversion rate from PSVT to sinus rhythm within 30 minutes compared to the placebo group.

What is the potential market for etripamil in China?

If regulatory approval is secured, etripamil represents a potential breakthrough treatment for the millions afflicted by PSVT in Greater China.

How does etripamil function as a treatment?

Etripamil is a self-administered nasal spray that acts as a calcium channel blocker, helping to control and manage episodes of rapid heart rate conditions effectively.

What safety data has been reported regarding etripamil?

In the latest trial, the safety profile of etripamil was found to be consistent with previous studies, with no significant adverse events observed among users.

Who can provide more information about Milestone Pharmaceuticals?

For inquiries, contact Kim Fox at Milestone Pharmaceuticals via email at kfox@milestonepharma.com.

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