Paroxysmal supraventricular tachycardia

Learnings from the Field: Managing PSVT and Studying AFib-RVR in the Community Setting Hosted 10 am ET, Tuesday, October 8, 2024 MONTREAL and CHARLOTTE, N.C., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced it will host Part 2 of its virtual investor education series on Tuesday, October 8, 2024 from 10:00 AM ET to 11:30 AM ET. To register for “Learnings from the Field: Expert Perspectives on Managing PSVT and Studying AFib-RVR in the Community Setting”, click here. The event will feature Aamer H. Jamali MD, FACC and Farhad Rafii, MD, FACC from Interventional Cardiology Medical Group in West Hills, CA, who will discuss the burden of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib) on patients and how these conditions are managed in their practice. It will also highlight clinical trial experience in PSVT and upcoming trials in atrial fibrillation with rapid ventricular rate (AFib-RVR) with the potential to impact the current standard of care. A live question and answer session will follow the formal presentation. About Aamer H. Jamali, MD, FACC Aamer H. Jamali, MD, FACC, a cardiologist at Interventional Cardiology Medical Group, holds an appointment as an Assistant Clinical Professor of Medicine at UCLA School of Medicine, and is affiliated with the Smidt Heart Institute at Cedars-Sinai. Dr. Jamali has been practicing medicine in the San Fernando Valley for over 16 years. He launched the first structural heart program in the valley, offering cutting edge procedures such as PFO/ASD closure, watchman, and minimally invasive aortic valve surgery to the local community. He has also served as Chief of Medicine and as Chief of Staff at West Hills Hospital. Additionally, Dr. Jamali serves as the Secretary of SBMAA, an international non-profit organization devoted to healthcare equality. Dr. Jamali graduated with highest honors from the University of California, Berkeley, attended the UCLA School of Medicine and chose Stanford University for his post-graduate training in Internal Medicine. He completed fellowships in General and Interventional Cardiology at Cedars-Sinai Medical Center, where he also served as Chief Fellow. Dr. Jamali has published in multiple scientific journals, written textbook chapters, and presented at international cardiology conferences. About Farhad Rafii, MD, FACC Farhad Rafii, MD, FACC, a cardiologist at Interventional Cardiology Medical Group, is Clinical Assistant Professor of Medicine, Keck School of Medicine of the University of Southern California, Volunteer Faculty, and Clinical Assistant Professor of Internal Medicine, Western University of Health Sciences/College of Osteopathic Medicine of the Pacific. Dr. Rafii joined Interventional Cardiology Medical Group in August 2013. He holds five board certifications and is a Diplomate of the American Board of Internal Medicine, Board of Cardiovascular Diseases, the National Board of Echocardiography, International Board of Heart Rhythm Examiners, and the Certification Board of Nuclear Cardiology. He graduated Keck School of Medicine of the University of Southern California class of 2007, completed his internal medicine residency at UCLA – Kaiser Permanente Los Angeles Medical Center, and subspecialty training at UCSF – Fresno Cardiology Fellowship program. He has been elected a Fellow of the American College of Cardiology. Dr. Rafii has co-authored and published multiple manuscripts and original research articles in major cardiovascular journals. His clinical interests include prevention and treatment of coronary artery disease and heart attacks, heart failure, disorders of heart valves and heart rhythm, cholesterol abnormalities, hypertension, and heart disease in women. About Interventional Cardiology Medical Group (ICMG) Founded nearly 40 years ago, ICMG’s community-based cardiology team of physicians, nurse practitioners, sonographers, radiation technologists, research staff and patient care coordinators have distinguished itself as the preeminent cardiology practice in the West Valley area (suburban Los Angeles, CA). About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About Atrial Fibrillation with Rapid Ventricular Rate An estimated five million Americans suffer from atrial fibrillation (AFib), a common arrhythmia marked by an irregular, disruptive and often rapid heartbeat. The incidence of AFib is expected to grow to approximately 10 million by 2025 and up to about 12 million by 2030. A subset of patients with AFib experience episodes of abnormally high heart rate most often accompanied by palpitations, shortness of breath, dizziness, and weakness. While these episodes, known as AFib-RVR, may be treated by oral calcium channel blockers and/or beta blockers, patients frequently seek acute care in the emergency department to address symptoms. In 2016, nearly 800,000 patients were admitted to the emergency department due to AFib symptoms where treatment includes medically supervised intravenous administration of calcium channel blockers or beta blockers, or electrical cardioversion. With little available data for AFib-RVR, Milestone's initial market research indicates that 30 to 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market of approximately three to four million patients in 2030 for etripamil in patients with AFib-RVR. About Etripamil Etripamil is Milestone's lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR). It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™ (etripamil) nasal spray, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals 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. Contact:Kim Fox, Vice President, Communications,kfox@milestonepharma.com Investor RelationsChris Calabrese,ccalabrese@lifesciadvisors.com Kevin Gardner,kgardner@lifesciadvisors.com Source: Milestone Pharmaceuticals Inc.

Sept. 06, 2024 -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced its licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a multi-center, randomized, double-blind, placebo-controlled trial in China evaluating the efficacy and safety of etripamil nasal spray in paroxysmal supraventricular tachycardia (PSVT). The trial design closely matched the RAPID Phase 3 Study of etripamil in PSVT conducted by Milestone in North America and Europe. The 500-patient Phase 3 trial (JX02002) met its primary endpoint, with a Kaplan Meier analysis shows a statistically significantly greater proportion of patients who self-administered etripamil converted from PSVT to sinus rhythm within 30 minutes compared to placebo (40.5% vs. 15.9%, respectively; hazard ratio [HR] = 3.00; 95% CI 1.58-5.71; p<0.001). Statistically significant (p<0.05) results were also shown for the secondary efficacy endpoints for percent of patients’ PSVT converted to sinus rhythm by 10, 15, 45, and 60 minutes after self-administration of study drug. Ji Xing further reported that, overall, treatment emergent adverse events were comparable between treatment groups, and there were no reported serious adverse events related to etripamil. The safety and tolerability data from the JX02002 trial were consistent with previous clinical studies. This important study further expands the etripamil global development program to more than 2,000 unique patients treated with etripamil. "Congratulations to Ji Xing and all the clinical investigators on the successful completion of this large Phase 3 study of etripamil in PSVT," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are proud to partner with our colleagues at Ji Xing as they advance etripamil toward regulatory approval in China, with the potential to help millions of patients struggling with PSVT." Under the terms of the license agreement announced on May 21, 2021, Milestone granted Ji Xing an exclusive license to develop and, if regulatory approval is obtained, commercialize etripamil in patients with PSVT in Greater China. Milestone received an upfront cash payment consisting of $15 million along with a $5 million equity investment by RTW Investments, LP. In addition, Milestone remains eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China (including Mainland China, Hong Kong, Macau & Taiwan). Milestone supplies etripamil and delivery devices to Ji Xing. Ji Xing is responsible for development and commercialization costs in Greater China. An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden-onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. Etripamil is Milestone's lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR). It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™ (etripamil) nasal spray, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. 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. 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Milestone’s calcium channel blocker succeeded in a late-phase trial in China in people with an abnormal heart rhythm disorder, supporting ongoing efforts for an approval in the country as the FDA simultaneously reviews its US filing. Etripamil is a self-administered nasal spray designed to treat paroxysmal supraventricular tachycardia (PSVT). The disorder causes unpredictable spikes in heart rates exceeding 150 to 200 beats per minute. In the primary endpoint of the 500-participant Phase 3 trial in China, 40.5% of patients taking etripamil switched from PSVT to sinus rhythm within 30 minutes of treatment administration compared with 15.9% of placebo patients (p<0.001). The study also met key secondary endpoints of conversion to sinus rhythm by 10, 15, 45 and 60 minutes after treatment. Safety-wise, side effects in this trial were consistent with previous studies of etripamil, and there were no serious adverse events related to the drug, according to a release on Friday. Milestone’s partner Ji Xing is currently working toward an approval of etripamil in China, where it is responsible for overseeing the drug’s development and commercialization under the terms of a 2021 licensing agreement . That deal saw Ji Xing pay $15 million upfront, with Milestone receiving a further $5 million equity investment from RTW Investments. Elsewhere, in May, the FDA accepted Milestone’s etripamil NDA, which included results from the company’s CARDAMYST trial program. The agency set a PDUFA date for March of next year. Milestone’s first attempt at a US submission was met with a refuse-to-file action in December, prompting it to restructure certain datasets and reformat files earlier this year before making a second attempt.