As Health Problems Mount Patients Welcome New Treatments

By Patricia Miller

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Healthcare is changing, as more and more diseases pose a growing concern for society and the companies trying to cure them.

There are several serious health problems facing society today. Some, like heart disease, gastrointestinal diseases, cancer, and diabetes, pose a growing burden to health care systems and humanity alike. As health-aware patients seek a diagnosis from a younger age and populations live longer, cases are mounting. Here we discuss growing health problems with reference to Takeda Pharmaceutical (NYSE: TAK), Abbott Laboratories (NYSE: ABT), Bristol-Myers Squibb (NYSE: BMY), Novo Nordisk (NYSE: NVO), and Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL).

Takeda is making progress in treating cancer and gastrointestinal conditions, Bristol-Myers Squibb is making strides in oncology medications, Abbott labs is tackling diabetes, and Novo Nordisk is developing life-altering diabetes and weight loss drugs.

Meanwhile, heart failure comes in various forms, and some, such as acute myocarditis and diastolic heart failure, currently have no recognized standard of care.

Heart failure has remained the leading cause of death globally for the last 20 years, further exacerbated by mounting diabetes, obesity, and high blood pressure cases. This devastating condition comes in several forms, but ultimately leads to diminished quality of life and death.

Every year, over 550,000 new cases are diagnosed in the U.S. That's why Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) is working vigorously to develop treatments to help people live more comfortably with this destructive disease.

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

The company currently has one multi-national clinical trial ongoing, with another expected to commence shortly. Furthermore, it just announced its third FDA IND authorization for its flagship formulation CardiolRx™ in cardiovascular disease.

Altogether, the company is looking to treat acute myocarditis, recurrent pericarditis, and diastolic heart disease.

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 with the company's multi-national Phase II acute myocarditis trial, which is expected to commence imminently.

The company will evaluate whether this intervention could be a therapeutic option for those who are intolerant to current medical treatment or who require long-term administration of corticosteroids to control their disease.

Dr. Allan L. Klein, 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.

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.

Causes of pericarditis can include infection (e.g., tuberculosis), systemic disorders such as autoimmune and inflammatory diseases, cancer, and post-cardiac injury syndromes.

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 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, particularly for colchicine-resistant, intolerant, refractory, and contraindicated patients, and steroid-dependent patients.

With the world facing intensifying healthcare challenges, doctors welcome breakthroughs in treating the most prevalent of diseases.

Takeda Pharmaceutical (NYSE: TAK) recently launched two new products, lung cancer med Exkivity and anti-cytomegalovirus drug Livtencity. 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.

Abbott Laboratories (NYSE: ABT) 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.

Bristol-Myers Squibb Co (NYSE: BMY) is acquiring Turning Point Therapeutics, a leading precision oncology company. The acquisition brings Repotrectinib, a potential best-in-class, next-generation ros1/ntrk inhibitor with differentiated duration of response for patients with ros1-positive first-line non-small cell lung cancer. This drug is expected to launch in 2023. BMY’s all-cash tender offer will acquire all outstanding shares of turning point therapeutics for $76 per share.

Novo Nordisk A/S (NYSE: NVO) announced headline results from the main phases of its ONWARDS 1 (52 weeks) and ONWARDS 6 (26 weeks) phase 3a trials with once-weekly insulin icodec. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile. This has the potential to become the ideal insulin for people with type 2 diabetes initiating insulin treatment.

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