CORXEL Announces NMPA Acceptance of New Drug Application for Etripamil
SHANGHAI, China, January 17, 2025 – Corxel Pharmaceuticals (CORXEL), a leading biotech company committed to bringing innovative science and medicines to underserved patients with cardiometabolic diseases around the world, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China has accepted the New Drug Application (NDA) for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT).
Etripamil is a fast-acting non-dihydropyridine L-type calcium channel blocker (CCB) developed by Milestone Pharmaceuticals for the treatment of PSVT and other cardiac arrhythmias. In an unsupervised medical situation (e.g., at home), patients can self-administer etripamil to rapidly terminate an acute PSVT episode. PSVT is a condition characterized by abnormalities in the heart's electrical system that can lead to unexpected, symptomatic tachycardia. One unmet medical need is the early cessation of PSVT. In China, there are currently no self-administered, fast-acting, non-injectable medical treatments approved for acute PSVT.
The acceptance of this NDA is based on the results of data obtained from the pivotal Phase 3 RAPID study and the Phase 3 JX02002 study in China. Both trials met their primary endpoint. Patients of the JX02002 study who administered etripamil showed a significantly faster recovery of PSVT to sinus rhythm within 30 minutes compared to placebo (hazard ratio [HR] = 3.02; p=0.0005). Overall, the treatment emergent adverse events (TEAEs) were comparable between etripamil and placebo group. Notably, no serious adverse events (SAEs) were reported within 24 hours of etripamil administration in any Phase 3 trial.
“We believe this innovative treatment will provide a brand new option for PSVT patients in China, potentially empowering them to manage their health conditions more autonomously and to quickly access effective treatments even when they are outside of the hospital,” said Sandy Mou, MD, Board Executive Director and Chief Executive Officer of CORXEL, “ Meanwhile, by reducing the frequency of emergency room visits and through other means, this treatment may also have a positive impact on the overall healthcare system. Next, we will actively collaborate with the CDE to enable Chinese patients to benefit from this innovative drug as soon as possible.”
Additional information
Approximately 2.3-4 in 1,000 people have PSVT, resulting in an estimated overall patient population of 3-6 million in China. PSVT is characterized by intermittent episodes of a rapid heartbeat that starts and stops suddenly. Episodes of supraventricular tachycardia (SVT) are often associated with symptoms such as palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain intravenous medications, including adenosine, beta-blockers and calcium channel blockers, have long been used for the acute treatment of PSVT. However, these medications must be administered under medical supervision, usually in an emergency department or other acute care setting.
Etripamil, a new chemical entity, is the lead investigational product of Milestone Pharmaceuticals Inc. (Nasdaq: MIST). It 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 a medically unsupervised setting. In May 2021, JIXING and Milestone entered into an exclusive license agreement for the development and commercialization of the investigational drug etripamil for the treatment of PSVT and other cardiovascular diseases in Greater China.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.
CORXEL, is a leading biotech company headquartered in US and China focused on developing innovative cardiometabolic therapies globally. CORXEL was founded in 2019 and has been committed to bringing innovative science and medicines to underserved patients around the world. With a strong and further developing asset pipeline, industry leading talent, and patient-centric focus, CORXEL is dedicated to delivering a meaningful and lasting impact on patients.
The portfolio of CORXEL consists of 3 assets with global rights and 2 assets with Greater China rights in late-stage clinical development. The portfolio with global rights covers CX11 for obesity and diabetes, JX10 for acute ischemic stroke (AIS) and JX09 for hypertension, while the portfolio with Greater China rights includes Etripamil and LNZ100.
For further information about CORXEL, please visit www.corxelbio.com
