Particulate matter or particle pollution is a significant contributor to heart and lung disease. Individuals most affected by poor air quality have asthma, chronic obstructive pulmonary disease (COPD), and heart disease. Some of the companies tackling these soaring health problems include GlaxoSmithKline (NYSE: GSK), AstraZeneca (NASDAQ: AZN), Regeneron Pharmaceuticals Inc (NASDAQ: REGN), and Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL).
Particulate matter pollution is prevalent because their minuscule size means people often inhale these particles effortlessly. They then infiltrate blood vessels, damaging the heart and lungs. Familiar sources include automobile and diesel generator emissions, wood and tobacco smoke, wildfires and even fireworks.
Despite extensive efforts to combat climate change, it seems the world has a long way to go to achieve clean air all around. This means any help to alleviate the associated health concerns is warmly welcomed.
Last year GSK began an R&D program to redevelop and redesign its rescue metered-dose inhalers (MDIs) to lower its carbon emissions while continuing to provide relief to asthmatics.
A recent asthma study published in the British Medical Journal (BMJ) showed that patients switching from a pressurized metered-dose inhaler (pMDI) to a dry powder inhaler (DPI)-based maintenance therapy more than halved their inhaler carbon footprint without loss of asthma control.
Regeneron Pharmaceuticals, along with The National Institute of Allergy and Infectious Diseases (NIAID) and Sanofi, are co-funding a Phase 2 clinical trial. This will test whether a monoclonal antibody, dupilumab, can reduce asthma attacks and improve lung function and asthma symptoms in children with poorly controlled allergic asthma who live in low-income urban neighborhoods.
Meanwhile, AstraZeneca is on a mission to transform the treatment of asthma and COPD by driving earlier, biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death.
However, cardiovascular diseases remain the world’s primary cause of death. Indeed, more than 800,000 Americans suffer from heart attacks annually, according to the Centers for Disease Control and Prevention (CDC). Furthermore, 2018 CDC data indicates more than 30 million Americans live with heart disease.
Inhaling microscopic pollution particles can lead to arrhythmia, inflammation and hypercoagulation.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) is one company attempting to tackle the debilitating effects of heart conditions. The company aims to treat inflammatory heart conditions of acute myocarditis, recurrent pericarditis, along with diastolic heart failure.
Cardiol Therapeutics is developing CardiolRx™, a pharmaceutically produced oral cannabidiol formulation to potentially treat acute inflammation associated with heart disease.
Cardiol currently has one multi-national clinical trial ongoing with another expected to commence imminently. Plus, it recently announced its third FDA IND authorization for its flagship formulation CardiolRx™ in cardiovascular disease.
Altogether, the company is looking to treat three areas of concern that would greatly benefit from an alternative treatment breakthrough.
PHASE II RECURRENT PERICARDITIS TRIAL
Cardiol's latest IND authorization is for a multicenter Phase II open-label pilot study of CardiolRx™ for recurrent pericarditis. This study will run parallel to the company's multi-national Phase II acute myocarditis trial.
Cardiol's recurrent pericarditis study will also assess the improvement in objective measures of disease and, during an extension period, evaluate the feasibility of weaning concomitant background therapy, including corticosteroids, while taking CardiolRx™.
Allan L. Klein, MD, FRCP (C), FACC, FAHA, FASE, FESC, Director Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, Cleveland Clinic, will serve as study Chair and provide leadership throughout the trial.
Cardiol's study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the United States. The study protocol has been designed in collaboration with well-established thought leaders in pericardial disease.
Cardiol Therapeutics’ Chief Medical Officer, Dr. Andrew Hamer, commented:
“With Investigational New Drug authorization now in place, we look forward to ramping up initiation of this important study. We also anticipate benefiting from the clinical trial infrastructure already established for our multi-national acute myocarditis study, which is expected to commence patient enrollment imminently.”
Pericarditis refers to inflammation of the pericardium – the membrane or sac surrounding the heart. Symptoms include debilitating chest pain, shortness of breath, and fatigue, which result in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.
Based on the time of presentation, acute pericarditis is a symptomatic event lasting less than four to six weeks. The diagnosis is based on meeting two of four criteria: chest pain, pericardial rub; electrocardiogram changes; and new or worsening pericardial swelling. Elevation of inflammatory markers such as CRP and evidence of pericardial inflammation by an imaging technique (computed tomography scan or cardiac magnetic resonance) may help diagnose and monitor disease activity.
Although generally self-limited and not life-threatening, acute pericarditis is diagnosed in 0.2% of all in-hospital cardiovascular admissions. It is responsible for 5% of emergency room admissions for chest pain in North America and Western Europe.
Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least 4–6 weeks following an episode of acute pericarditis. These recurrences appear in 15% to 30% of acute cases, usually within 18 months. Up to 50% of patients with a recurrent episode of pericarditis experience more recurrences.
Cardiol believes there is a significant opportunity to develop a novel, well-tolerated, and safe therapy for treating recurrent pericarditis to prevent multiple recurrences in the first place.
Moreover, both acute myocarditis and recurrent pericarditis have a prevalence under 200,000 people in the United States. This means CardiolRx™ is eligible for orphan drug status in two indications, potentially adding significantly more value to the company.
Air pollution is a rapidly growing primary health concern around the world. Medical solutions are the next best option if pollution can't be eradicated.
GlaxoSmithKline (NYSE: GSK) is a leader in treating respiratory disease, producing MDIs that use a propellant to deliver the medicine and Dry Powder Inhalers (DPIs) which are propellant free. GSK’s latest generation of inhaler products that use the Ellipta device were developed and launched as DPIs and have an acknowledged lower carbon footprint than MDIs.
AstraZeneca (NASDAQ: AZN) is working with governments and policymakers worldwide to address systemic challenges and make COPD a public health priority. It aims to cut the COPD exacerbation rate in half by 2030 and thus reduce the associated cardiovascular mortality risk.
Regeneron Pharmaceuticals Inc (NASDAQ: REGN) enjoyed European Commission (EC) approval of its Dupixent (Dupilumab) drug for the treatment of severe asthma in children aged 6 to 11 years in April 2022.