The research encompasses both clinical and pre-clinical stages of development with the ultimate aim of supporting the application of its products for the treatment of various health conditions, with a significant focus on the clinical areas and indications listed below. The trials to date have been positive and supportive of HBC’s confidence that it has unique products for the human and pet health supplement market, and thus also as potential medicine in the future
Reducing Gastrointestinal (GI) inflammation – Necrotizing Enterocolitis (NEC) to Inflammatory Bowel Disease (IBD): NEC is a serious inflammatory condition of the neonatal GI tract with a mortality rate of 20-30%. It is predominantly a condition of preterm infants, with the risk of developing NEC increasing with diminishing birthweight. There have been no significant improvements in outcome for several years. However, the scientific understanding of the underlying process has greatly increased.
Professor Karl Sylvester at the Stanford School of Medicine (SSM) is currently working on SSM’s proprietary animal model of NEC. ProGo® (salmon protein hydrolysate) boosted markers of GI protection in the NEC animal model and lab work on human GI cell lines showed ProGo® to reduce inflammation and to upregulate genes that protect against oxidative stress. Taken together this work suggests that ProGo® has significant potential for GI-protection and improved outcomes in NEC. Further preclinical work of ProGo® in NEC is to be undertaken during 2020, in conjunction with SSM.
IBD is a common intestinal disorder causing pain in the stomach, bloating, diarrhea, and constipation. Twelve percent of people in the US estimated to suffer with IBD. The cause of IBD is not well understood, with the diagnosis based on symptoms and the exclusion of other conditions such as inflammatory bowel disease. Current treatments include self-care, including dietary modification, exercise, stress management and relaxation techniques. The cause of IBD remains unclear. Low grade intestinal inflammation is seen especially in IBD following gastroenteritis as well as altered GI barrier function. The company believes that the GI-protective properties seen with ProGo®, including anti-inflammatory and antioxidant effects, could provide benefit in the management of IBD and invitro work is ongoing.
Prostate cancer is male cancer that occurs in the prostate — a small walnut shaped gland in men that produces the seminal fluid that nourishes and transports sperm. 1 in 9 men will be diagnosed with prostate cancer.
CFS is also referred to as myalgic encephalomyelitis (ME). It is a disorder characterized by extreme fatigue or tiredness that doesn't go away with rest and can't be explained by an underlying medical condition. Studies estimate that 836,000 to 2.5 million Americans and 250,000 people in the UK have CFS.
Diabetes is characterized by elevated blood glucose (blood sugar) levels and commonly raised blood lipids and systemic inflammation. It is often associated with being overweight and obese. Insulin, a hormone made by the pancreas, helps move glucose from food into the cells of the body to be used for energy. In diabetes the effect of insulin is reduced (this is often referred to as insulin resistance) and blood glucose rises. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputations.
The WHO estimates it was the seventh leading cause of death in 2016. By treating at an earlier stage, prediabetes, it is possible to reverse insulin resistance and associated metabolic changes and stop the progression to diabetes. The pro-metabolic effects of SPH along with antioxidant and anti-inflammatory actions indicates an interesting potential to help reverse prediabetes.
Sarcopenia literally means "lack of flesh". Whilst ageing is associated with progressive muscle loss – on average after middle age, adults lose 3 % - 8 % of their muscle strength every year – sarcopenia sufferers have greater muscle loss and functional deterioration than their-age matched peers. Sarcopenia leads to higher disability and mortality rates along with higher healthcare costs.
Based on the results of a meta-analysis conducted by the Journal of Diabetes and Metabolic disorders, the overall prevalence of sarcopenia was 10 % in adults over 60 years (the survey used c.60k individuals) with higher rates seen in individuals in long term residential care. Sarcopenia has been associated with reduced anabolic signaling (leading to reduced protein production), chronic low-grade inflammation and dietary factors such as reduced protein consumption. A reduced ability to deal with reactive oxygen species with accumulated damage at a cellular level has also been implicated.
The high bioavailability of the peptides in ProGo® along with ProGo® antioxidant and anti-inflammatory effects looks an interesting profile for sarcopenia. Invitro work is ongoing.
Osteoporosis is the most common bone disease in humans. Osteoporosis is a disease that is characterized by low bone mass and deterioration of bone structure with an increased risk of non-traumatic fractures, most commonly in the spine, hip and wrist. It results in decreased quality of life, increased disability and potentially reduced lifespan.
The International Osteoporosis Foundation (IOF), has estimated that worldwide 1 in 3 women over the age of 50, and 1 in 5 men will experience osteoporotic fractures in their lifetime. Unsurprisingly, it carries a huge financial burden to health systems around the world. With early diagnosis and treatment osteoporosis can be significantly slowed or even prevented.
Preclinical work with HBC’s marine calcium, CalGo®, has shown superior biomarker data on bone formation in human osteoblasts (the bone producing cells) compared to commonly used calcium supplements. CalGo® has also shown significant increases in bone mineral density (BMD) and cortical thickness (bone strength) in animal studies compared to commonly used calcium supplements. Based on the strength of this data HBC will undertake a phase 2 trial of CalGo® vs standard calcium supplementation to assess the relative impact on BMD in postmenopausal women. HBC also plans to initiate a pilot study of CalGo®’s impact on joint health in mild osteoarthritis during H1 2021.
Cardiovascular disease generally refers to conditions that involve narrowed or blocked blood vessels leading to heart attack, angina (chest pain) or stroke. Other heart conditions, such as those that affect the heart's muscle, valves or rhythm, also are considered forms of heart disease. Heart disease is the leading cause of death in the US for men and women. Common causes include smoking, raised blood pressure, obesity, raised cholesterol and diabetes. Despite new treatments for improving diabetes control and reducing cholesterol levels, CV disease remains a major health issue: according to the CDC, about 610,000 people die of heart disease in the United States every year – 1 in every 4 deaths.
Preclinical and clinical work by HBC has shown a lipid fraction within OmeGo® reduces oxidized-LDL- glycoprotein 1 complex (oxLDL-Gp1). OxLDL-Gp1 is pro-inflammatory, pro-atherogenic and an independent risk factor for CV disease. HBC is planning to undertake further work in 2020 to assess the potential role of the lipid fraction in OmeGo® to reduce CV disease.
Iron deficiency anemia (IDA) is the most common type of anemia – a condition in which blood lacks adequate numbers of red blood cells. Red blood cells carry oxygen to the body’s tissues for the production of energy. As a result, anemia can result in fatigue, palpitations, shortness of breath and delayed healing. As the name implies, iron deficiency anemia is due to a lack of iron either from inadequate intake or from increased demands for iron (such as in athletes, children and women of childbearing age). Globally, anemia effects 1.62 billion people. It corresponds to 24.8 % of the global population according to the WHO. Iron sulphate tablets are used to help treat IDA but the 2-3 times a day regimen can be difficult for patients to adhere to and can result in a high rate of GI side effects including constipation and bloating.
ProGo® is currently under review with Health Canada (HC) for a nutraceutical claim for the prevention of IDA. The application was based on trial data showing that ProGo® normalized blood ferritin levels (a marker of body iron stores) and almost fully corrected IDA in otherwise healthy adults after 6 weeks treatment of a single 18g sachet of ProGo® taken once daily. HC’s review of HBC’s IDA label claim continues positively however the COVID-19 crisis has put significant pressure on global regulatory health agencies. As such a decision may not be reached until August 2020, a slight delay over previously anticipated timelines.
Obesity is a medical condition that occurs when a person carries excess weight or body fat that might affect their health. Body mass index (BMI) is the most commonly used method to assess whether an individual is at a healthy weight or not. A BMI of 30 or over suggests that a person may have obesity. A new study, published in the New England Journal of Medicine, found that about a third of the global population — including adults and children—exceed a healthy weight.
Estimates from ongoing health surveys in the US suggest that by 2030, 75 % of the US adult population is likely to be obese. Obesity can cause a number of health issues including accelerated joint damage / osteoarthritis, increased risk of diabetes, raised blood lipids, raised blood pressure and increased risk of cardiovascular disease along with an underlying inflammatory state. Weight loss of 5 % or more has been shown to have a significant benefit on health.
A 6-week trial of ProGo® in overweight but otherwise healthy adults showed a 5.9 % reduction in BMI (around 4kg loss in weight on average) without changing any lifestyle factors such as food intake and exercise. The comparator was whey protein which showed a 1.6 % increase in BMI. Bile acids were significantly raised by ProGo®, driving the metabolism to burn more fat, along with underlying biomarkers of metabolic health / insulin sensitivity. IL-6, a potent marker of systemic inflammation, was significantly reduced supporting the benefit of ProGo® in the management of weight.
Retarding the progress of Rheumatoid Arthritis (RA) without anti-inflammatories: RA is an autoimmune disease in which the body's immune system – which normally protects its health by attacking foreign substances like bacteria and viruses – mistakenly attacks the joints. Osteoarthritis (OA) typically only affects one joint, while RA commonly affects multiple joints. A key difference between these forms of arthritis is that RA involves a range of systemic symptoms - symptoms that affect the entire body. RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population. Invitro work with ProGo® is ongoing. In osteoarthritis HBC plans to initiate a clinical trial during 2020 to assess the benefit of CalGo on joint health in early OA.