JIXING Announces the First Patient Enrollment in Phase 3 Study of Etripamil in China
Etripamil has the potential to shift current treatment experience from the hospital to an at-home setting for patients with paroxysmal supraventricular tachycardia (PSVT)
SHANGHAI, China, July 1, 2022 – Ji Xing Pharmaceuticals Limited (JIXING), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved Chinese patients with serious and life-threatening diseases, announces the first patient enrollment at Nanfang Hospital of Southern Medical University in its phase 3 study of etripamil in China for the treatment of paroxysmal supraventricular tachycardia (PSVT). The study is currently being carried out in more than 40 leading clinical centers across China. The study is designed to evaluate the efficacy and safety of self-administered etripamil nasal spray as treatment of PSVT and to provide clinical data to support a new drug application in China. It is the first phase 3 study initiated by JIXING in China.
Etripamil, developed by Milestone Pharmaceuticals (Milestone), is a calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for PSVT patients from the emergency department to a medically-unsupervised setting.
“PSVT patients typically have multiple, unpredictable disease episodes per year, leading to a significant impact on their quality of life. Currently, termination of acute episodes often requires emergency-setting administration of IV calcium channel blockers and IV antiarrhythmics.” said Professor Changsheng Ma, Principal Investigator of the etripamil phase 3 study in China, Chairman-designate of the Cardiovascular Branch of the Chinese Medical Association, Director of National Clinical Research Center for Cardiovascular Diseases, Director of Cardiology Center of Beijing Anzhen Hospital of Capital Medical University. “We hope etripamil can provide more treatment options for PSVT patients in China, enabling a convenient and effective rapid treatment outside of the hospital setting.”
The etripamil phase 3 study is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray, self-administered by patients, who experience an episode of PSVT in an at-home setting.
Paroxysmal supraventricular tachycardia (PSVT) is a type of abnormal heart rhythm (arrhythmia) characterized by unpredictable acute episodes in which the heartbeat commonly exceeds 150-200bpm. Abrupt supraventricular tachycardia episodes commonly lead to palpitations, shortness of breath, chest pressure, lightheadedness, fatigue and anxiety. PSVT is caused by abnormal electrical connections in the heart that lead to irregular contraction.
Approximately 2.3-4 in 1,000 people have PSVT, resulting in an estimated overall patient population of 3-6 million in China. Currently, termination of acute episodes requires emergency-setting administration of IV calcium channel blockers and IV antiarrhythmics. Patients typically have multiple, unpredictable PSVT episodes per year, leading to a significant impact on their quality of life.
Etripamil, Milestone's lead investigational product, is a calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to a medically-unsupervised setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in PSVT and a Phase 2 proof-of-concept trial underway in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR).
In May 2021, Milestone and JIXING announced an exclusive license and collaboration agreement to develop and commercialize the investigational drug etripamil in patients with PSVT and additional cardiovascular conditions in Greater China. In November 2021, JIXING announced the National Medical Products Administration of the PRC (NMPA) had approved the Clinical Trial Application (CTA) for the initiation of phase 1 and phase 3 study of etripamil in patients with PSVT in China. Phase 1 study aims to evaluate the safety and tolerability of etripamil in healthy Chinese subjects and phase 3 study aims to evaluate the efficacy and safety of etripamil self-administration in PSVT.
JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in Greater China.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST), is a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. Milestone's lead product candidate etripamil is currently in a Phase 3 clinical-stage program for the treatment of PSVT and in a Phase 2 proof-of-concept trial for the treatment of patients with atrial fibrillation with AFib-RVR. Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com
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