Big strides are being made in collagen clinical development, particularly in treatment of age-related conditions. Dr Gen Li, president and founder of Phesi, discusses the increase in collagen research, and its clinical and biological applications.

According to the World Health Organisation, one in six people worldwide will be 60 years old or over by 2030, and the number of persons aged 80 or older is expected to triple between 2020 and 2050, reaching 426 million.

Advances in medical science and technology have greatly improved public health and increased life expectancy, but the natural process of ageing has consequences spanning from a loss of elasticity in the skin to stiff joints and brittle bones, which affect patients’ quality of life.

As the proportion of older people worldwide is growing, interest in – and awareness of – age-related conditions has grown.

As a result, the clinical development community has turned its attention to medicines to treat age-related conditions, address quality of life issues, and prevent complications for ageing people.

The study of collagen is one such area. Collagens are a group of structural proteins that make up a crucial component of connective tissue and exist throughout the human body to improve its strength. Collagens are the most abundant protein in the human body, accounting for nearly a third of all proteins. Our bodies gradually produce less collagen over time and collagen fibres become weaker, which has a subsequent impact on joint and skin health.

The cosmetic industry has picked up on the potential for collagen in skincare and beauty products – but use cases for collagen don’t end here. The wider potential for collagen to improve the health of older persons has captured attention.

As a result, the global market for collagen supplements alone is expected to surpass $2 billion in revenue by 2030. The burgeoning popularity of collagen-based products prompted Phesi to review the evolution of clinical trials over the past decade that have concentrated on collagen and its potential therapeutic applications.

Our analysis of 2,358 clinical trials involving collagen showed a steady and linear growth in the number of trials from 2010 onwards, increasing by 142% between 2010 and 2019. The COVID-19 pandemic caused an inevitable decline in 2020, but the number of collagen trials quickly recovered and returned to pre-pandemic levels in 2021.

Interestingly, our research found that less than 5% of collagen clinical trials in the past 12 years relate to cosmetic applications, demonstrating that interest in applications to mitigate serious age-related conditions is high.

However, commercial support for clinical research is limited, with only 27% of collagen-related trials receiving industry funding. If clinical research into collagen can maintain its current momentum and benefit from greater funding, we have the potential to uncover a wealth of new and innovative therapies. These could include treating skin and bone diseases, as well as improving treatments for wound care and arthritic joints.

The discovery of new treatments for age-related conditions would mark a significant milestone and benefit the lives of millions. For instance, as the most common joint disease, osteoarthritis affects more than more than 500 million people worldwide, with women disproportionately impacted.

Osteoarthritis is more frequent in countries with established market economies where there is an aging population and a higher prevalence of obesity. There is currently no cure aside from joint replacement surgery, but clinical trials are underway to examine how collagen could treat symptoms such as joint inflammation and stiffness, which occur when cartilage wears down.

To help better the industry’s understanding of the use cases of collagen and bring more effective treatments to market faster, clinical trial design must be informed by patient-centric data and predictive analytics.

Data from historical and ongoing clinical trials will reduce the cost of development, minimise patient burden, and accelerate the speed that new therapies become available to patients in need – transforming patients’ quality of life.

To optimise clinical trials and eliminate avoidable protocol amendments – which are both costly and time-consuming – researchers’ understanding of the target patient population must be data-driven rather than perception-led.

Equipped with the right approach to data, the R&D industry has the opportunity to conduct cheaper, more effective clinical trials, and develop innovative treatments for age-related conditions.

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