As Myocarditis Debate Rages On, Heart Disease Cases Mount

By Kirsteen Mackay


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Few had heard of myocarditis before the pandemic, but now it’s a serious worry making global headlines. One company is hoping to treat it.

As COVID-19 vaccines for kids achieve the Centers for Disease Control and Prevention (CDC) recommendation, concern it could increase children’s chances of myocarditis has incurred deep debate. Myocarditis is a rare heart disease that causes inflammation of the heart muscle. Some companies tackling the world’s biggest health threats, such as heart disease, include Johnson & Johnson (NYSE: JNJ), Takeda Pharmaceutical Co Ltd (NYSE: TAK), Novo Nordisk A/S (NYSE: NVO), Bristol-Myers Squibb Co (NYSE: BMY), and Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL).

Myocarditis Concern

Moderna previously confirmed the FDA delayed approval of its child vaccination due to the risk of myocarditis. The concern came after instances of myocarditis transpiring in young men after their second dose of an mRNA vaccine. Acute myocarditis is a significant cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people under 35 years old. This is raising alarm and driving interest in workable treatments.

Before the pandemic, few had heard of myocarditis, but now it’s a serious worry and parents everywhere are discussing it.

For now, the risk of myocarditis appears to be deemed small, although the debate has drawn awareness of this inflammatory condition to the public domain.

Nevertheless, in some cases, myocarditis can lead to heart failure, so parental concern is warranted.

With myocarditis cases rising, it could further exacerbate the global heart failure problem. It’s not only devastating lives but adds pressure to healthcare providers and is a growing economic burden. According to the CDC, cardiovascular diseases (CVD) are the biggest cause of death, with more than 800,000 Americans suffering from heart attacks yearly. Sadly, this problem is mounting and is further exacerbated by obesity, diabetes, hypertension, and now COVID-19.

At a time when heart disease cases and other global health concerns are mounting, the desire for suitable treatments has never been greater.

At Novo Nordisk, cardiovascular researchers focus primarily on identifying new ways to treat cardiovascular diseases, particularly atherosclerosis and chronic heart failure. It is also developing life-altering diabetes and weight loss drugs. And Johnson & Johnson is working on treatments for respiratory diseases, which are often linked to heart disease.

Meanwhile, Takeda’s Flexbumin drug is an albumin solution indicated for use in cardiopulmonary bypass surgery. Bristol-Myers Squibb is advancing its research in cardiovascular diseases, and thankfully, Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) is doing something about myocarditis. This clinical-stage company is focused on researching and developing an anti-inflammatory and anti-fibrotic therapy for the treatment of CVD. Cardiol’s primary focus is on treating inflammatory heart conditions, particularly acute myocarditis, recurrent pericarditis, and diastolic heart failure.

Making Cardiovascular Strides With CardiolRx™

The company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation being clinically developed for use in cardiovascular medicine. The pre-clinical data for this is compelling, as it displays potent anti-inflammatory and anti-fibrotic properties. It's this data that has led so many esteemed individuals to back these trials and invest themselves in Cardiol’s journey.

Altogether there’s great excitement for the efficacy of CardiolRx™ in multiple use cases and, therefore, the potential for the company to profit from several revenue streams in the future. If its drug proves to be that elusive treatment, it will surely be a cause for celebration.

Cardiol currently has one multi-national clinical trial ongoing and has received IND authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two orphan disease indications: acute myocarditis and recurrent pericarditis. Cardiol’s Phase 2 multi-national, randomized, double-blind, placebo-controlled trial in acute myocarditis is expected to begin imminently. To run in parallel with the Company’s acute myocarditis trial is a multi-center Phase 2 open-label pilot study of CardiolRx™ for recurrent pericarditis.

With the world facing intensifying healthcare challenges, doctors welcome potential breakthroughs in treating rare diseases.

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Pharmaceutica is running the Heartline study with Apple to study atrial fibrillation and how wearable technologies can help people identify atrial fibrillation to reduce the likelihood of an adverse health outcome.

Takeda Pharmaceutical Co Ltd (NYSE: TAK) is a leader in bleeding disorders. The company recently signed a 15-year lease with BioMed Realty for building approximately 600,000 square feet of research and development (R&D) and office space. The state-of-the-art facility will allow Takeda, the largest life sciences employer in Massachusetts, to create a purpose-built R&D facility with laboratories of the future featuring modern design elements and upgraded technology to support the company in its efforts to advance innovation for patients. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). The company also makes targeted R&D investments in Plasma-Derived Therapies and Vaccines.

Novo Nordisk A/S (NYSE: NVO) has partnered with Echosens, a high-technology company offering liver diagnostic solutions. Together they hope to advance the early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.

Bristol-Myers Squibb Co (NYSE: BMY) is evaluating multiple novel agents to address the needs of patients with serious cardiovascular conditions. The company has established the Bristol Myers Squibb Foundation to focus on providing social support and services for vulnerable and under-resourced populations to both educate and reduce the cost of cardiovascular care.

Along with heart disease, additional global health concerns include gastrointestinal diseases, cancer, and diabetes. All of which poses a growing burden to health care systems and humanity alike.

Abbott Laboratories (NYSE: ABT) is tackling the growing threat of diabetes. It recently announced late-breaking clinical data that demonstrates its FreeStyle Libre® 3 system has an overall mean absolute relative difference (MARD) of 7.9%,1 making it the first and only 14-day continuous glucose monitoring (CGM) system to achieve a sub-8% overall MARD. The results were presented at the American Diabetes Association® (ADA) 82nd Scientific Sessions, June 3-7, 2022, in New Orleans.

Merck (NYSE: MRK) recently announced a collaboration with Finnish pharmaceutical company Orion. Merck hopes to develop and commercialize Orion’s ODM-208, an Investigational Steroid Synthesis Inhibitor for the treatment of metastatic castration-resistant prostate cancer. Merck will make an upfront payment to Orion of $290m, which will be expensed by Merck in Q3, 2022 and included in non-GAAP results. Merck is known as MSD outside of the United States and Canada. It is also studying its drug KEYTRUDA in early-stage cancers, with approximately 20 ongoing registrational studies across multiple types of cancer.

Novartis AG (NYSE: NVS) is a focused medicines company with depth in five core therapeutic areas (hematology, solid tumors, immunology, neuroscience and cardiovascular), strength in technology platforms (gene therapy, cell therapy, radioligand therapy, targeted protein degradation and xRNA), and a balanced geographic footprint. The company's key growth brands include Cosentyx, Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio. Its six key in-market growth drivers with multi-billion sales potential (Cosentyx, Entresto, Zolgensma, Kisqali, Kesimpta, Leqvio) each grew at least double digits during Q2, 2022.

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) is advancing breakthroughs in neuroscience to elevate life. Therapeutic areas it is investigating include acute and chronic pain and breakthrough treatment for Alzheimer’s disease psychosis. ACADIA is also trialing therapeutics to alleviate symptoms in the rare genetic neurodevelopment disorder Rett syndrome. The company submitted a New Drug Application (NDA) to the US FDA in July. This NDA is for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. Rett syndrome is a devastating disease with no approved therapies. The NDA submission is supported by results from the pivotal Phase 3 Lavender™ study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young women aged 5-20 years with Rett syndrome.

Medtronic PLC (NYSE: MDT) is an American medical device company and global leader in healthcare technology. In mid-July 2022, the American Society for Gastrointestinal Endoscopy (ASGE) announced they are expanding the Medtronic Health Equity Assistance Program for colon cancer screening in medically underserved communities across the United States, with support from Amazon (NASDAQ: AMZN) Web Services (AWS) Health Equity Initiative. The GI Genius units provided as part of the program have increased from 50 to 133 systems being placed at 62 facilities.


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