JIXING Announces IND Approval for Phase 1 and Phase 3 Clinical Trials of Etripamil in Patients with Paroxysmal Supraventricular Tachycardia (PSVT) in China
SHANGHAI, China. November 19, 2021 – JIXING Pharmaceuticals Limited (JIXING or the “Company”), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved Chinese patients with serious and life-threatening diseases, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the PRC (NMPA) has approved the Investigational New Drug (IND) application for the initiation of phase 1 and phase 3 clinical trials of etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) in China.
There are more than 3 million patients in China who suffer from PSVT which has a material impact on their health and quality of life.
Etripamil, originally discovered and developed by Milestone Pharmaceuticals Inc. (Milestone, Nasdaq: MIST), is a novel 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 an at-home setting. Milestone is conducting a comprehensive development program for etripamil, with a global phase 3 trial ongoing in PSVT and a phase 2 proof-of-concept trial now underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).
“There are more than 3 million patients in China who suffer from PSVT which has a material impact on their health and quality of life.” said Joseph Romanelli, CEO of JIXING, “We believe etripamil has the potential to shift the treatment paradigm for patients by allowing them to self-administer an effective treatment alternative compared to the burden of an intravenous (IV) administration within a hospital emergency room. Our goal with etripamil is to keep Chinese patients with PSVT healthy and out of the emergency room.”
Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning. It affects around 3 to 6 million Chinese based on published studies. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. However, calcium channel blockers approved for the termination of SVT episodes must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.
Backed by RTW Investments, LP, JIXING is a privately held, leading biotechnology company headquartered in Shanghai committed to bringing innovative science and medicines to underserved Chinese patients with serious and life-threatening diseases.
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