Tackling Recurring Health Conditions Offers Hope to Patients

By Patricia Miller

June 30th, 2022

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Being diagnosed with a health condition can often come as a shock but finding out it can recur is a double blow, particularly in the case of cancer or heart conditions. This reality is encouraging more companies to seek treatments for recurring conditions. Here we discuss companies treating recurring health conditions in reference to Merck (NYSE: MRK), Bio-Techne Corporation (NASDAQ: TECH), Natera (NASDAQ: NTRA) and Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL).

Triple-negative breast cancer is the most aggressive type of breast cancer, with the highest risk of recurrence within the first five years after diagnosis. Merck (NYSE: MRK) just had its drug KEYTRUDA® (pembrolizumab) plus chemotherapy approved by the European Commission to treat locally advanced or early-stage triple-negative breast cancer at high risk of recurrence. This offers enormous encouragement to those suffering from this devastating condition.

Meanwhile, Bio-Techne Corporation (NASDAQ: TECH) and Nonagen Bioscience announced an agreement to exclusively manufacture Nonagen Bioscience's Oncuria® bladder cancer diagnostic panel using xMAP Luminex® technology. Oncuria is the first-of-its-kind multiplex protein-based urine test to provide early and accurate detection, therapy choice, and disease monitoring of bladder cancer. Sadly, low-grade bladder cancers recur frequently.

Natera (NASDAQ: NTRA) is commercializing a personalized blood-based DNA test to detect and assess how much cancer is left in the body. This will help identify recurrence earlier and help optimize treatment decisions.

And private company Ferring Pharmaceuticals is investigating a live biotherapeutic to reduce recurrent C. difficile infection (CDI) after antibiotic treatment.

Any of these conditions can cause great anxiety to patients, and the potential to treat recurring conditions offers considerable hope of a healthier future. Particularly worrying are the health issues related to the heart. As the heart determines life and death, the shock of a heart condition can bring life to a halt.

Unfortunately, heart problems are not only linked to lifestyle choices but also as a side-effect of many other issues such as infection, autoimmune and inflammatory diseases, cancer, and post-cardiac injury syndromes.

The widespread instance of COVID-19 has led to a rise in heart conditions such as myocarditis and recurrent pericarditis. These are two conditions that Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) is working to treat.

Heart failure continues to persist as a leading cause of death globally, made worse by mounting diabetes, obesity, and high blood pressure cases.

Every year, over 550,000 new cases are diagnosed in the US That's why Cardiol Therapeutics aims to develop treatments to help people live more comfortably with this destructive disease. Their primary focus of interest is in treating acute myocarditis, recurrent pericarditis, and diastolic heart failure.

The company is focused on researching and developing an anti-fibrotic and anti-inflammatory therapy to treat cardiovascular disease (CVD). Its lead product candidate, CardiolRx™, is a pharmaceutically produced oral formulation being clinically designed for cardiovascular medicine use.

RECURRENT PERICARDITIS

Cardiol Therapeutics is delighted to have received a third IND authorization from the US FDA for its flagship formulation CardiolRx™ in CVD. This latest authorization is for a multi-center Phase II open-label pilot study of CardiolRx™ for recurrent pericarditis.

The company’s recurrent pericarditis study will run in parallel with its multi-national Phase II acute myocarditis trial, which is expected to commence imminently.

Dr. Andrew Hamer, Cardiol's Chief Medical Officer, commented:

"With IND 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."

Furthermore, this means CardiolRx™ is eligible for orphan drug status in two indications, potentially adding significant value to the company.

Pericarditis refers to inflammation of the pericardium – the membrane, or sac, that surrounds 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.

Cardiol's recurrent pericarditis study will 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™.

The 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.

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 and usually within 18 months. Up to 50% of patients with a recurrent episode of pericarditis experience more recurrences.

Cardiol Therapeutics believes there is a significant opportunity to develop a new oral, well-tolerated, and safe therapy for treating recurrent pericarditis to prevent multiple recurrences in the first place.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, declared a quarterly dividend of $0.69 per share for Q3 of 2022. Payment will be made on July 8, 2022, to shareholders of record at the close of business on June 15, 2022. Merck aspires to be the premier research-intensive biopharmaceutical company globally, advancing the prevention and treatment of diseases in people and animals.

Bio-Techne Corporation (NASDAQ: TECH) has extensive immunoassay expertise and world-class manufacturing capabilities. The U.S. FDA granted its drug Oncuria a Breakthrough Device Designation in September 2021, for predicting response to BCG therapy, a first-line treatment for bladder cancer. This provides formal acknowledgment of Oncuria's utility and potential clinical benefit.

Natera (NASDAQ: NTRA) is a diagnostics company, which engages in the discovery, development, and commercialization of genetic testing services. The company is dedicated to oncology, women's health, and organ health. Natera recently announced the appointment of Minetta Liu, M.D., as its new chief medical officer of oncology.

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