BE INNOVATIVE: The vital role of policy in supporting Alzheimer’s Disease research to accelerate innovation [Promoted content]

 

The leading cause of dementia, Alzheimer’s Disease (AD) has proven to be a significant challenge to the research community. Despite being a historically fragmented field, with wide variation in investment and a trial failure rate of 99% – decades of persistence in AD research have now begun to pay off, with new generation therapeutics recently succeeding in clinical trials to achieve regulatory approval.

For the past 30 years Eli Lilly has proudly been at the forefront of AD research and as we look ahead, we must ensure that current momentum is not lost. With the support of policymakers to deliver investment and strengthen current infrastructures, life science companies can commit greater resources to investigating new ideas to deliver more breakthroughs, ultimately helping more patients.

The AD landscape has been transformed by recent breakthroughs in research

Until recently, treatment approaches for AD had only been capable of temporarily reducing the impact of symptoms. Fortunately, as our understanding of AD has developed, researchers have uncovered new insights to power a revolution in treatment.

A recent addition to available therapeutic approaches for AD has been amyloid targeting therapies. These treatments can be utilized in the very early stages of AD to reduce levels of beta-amyloid protein in the brain, that if left unchecked form into plaques which cause damage. The goal of these therapies is to help patients remain in the earlier, milder stages of AD for longer; when individuals can continue to engage in daily activities such as going shopping, reading about or discussing current events, maintaining hobbies and appointments, and travelling independently.[i]

By targeting the underlying causes of AD with the aim of altering disease progression, science has shifted clinical perspectives on the management of this disease entirely, making rapid cognitive decline less of a tragic inevitability. If successfully implemented, this approach could give those affected more valuable time to spend with loved ones doing the activities they enjoy, as well as generating significant cost savings by delaying the need for residential care.

The potential of AD research is limitless, but further investment is vital

Despite the challenges of developing AD therapies, the global pipeline for new drugs in this space offers much cause for optimism, with researchers currently investigating a diverse range of therapeutic targets including inflammation, synaptic plasticity and transmitter effects. Reflecting this, Alzheimer’s Disease International has titled 2024 the ‘Year of Hope’ for AD research, leading the organization to host its first ever Forecast event in celebration of scientific progress.

As of the beginning of 2024 there were 164 clinical trials running, with nearly 50 of these in the large-scale Phase 3 stage.[ii] Such a significant number of later-stage candidates is the result of years of international collaboration, catalysed by the Common Alzheimer’s Disease Research Ontology (CADRO)² – an initiative developed in 2012 to prioritize AD treatment research between academia, key institutions and healthcare systems. Despite this positivity, it must also be acknowledged that the number of trials, drugs, and new chemical entities in the 2024 pipeline has fallen in comparison to 2023, suggesting that recent successes have not been enough to generate an increase in AD pipeline activity.²

“Scientific research holds the key to unlocking further transformation in treatment approaches for AD, but the policy and legal landscape faced by researchers remains incredibly challenging. We are committed to working with policymakers to facilitate better sharing of data and improve access to investment to speed up discovery for the benefit of all,” says David Talbot, Associate Vice President, International Government Affairs, Eli Lilly and Company.

Policymakers have the power to quicken the pace of innovation

Whilst scientific breakthroughs emerge from laboratories and specialist centres, their true potential can only be unlocked through decisive policy action. Currently, the total development time for a new potential AD therapy to progress from nonclinical studies to regulatory review is approximately 13 years.² The decisions made by policymakers today will have a direct impact in delivering and accelerating the necessary support and funding to incentivize life science companies to continue investing in this field.

Support for such research is not only vital to fuelling new discoveries but also to maximizing the potential of already approved medicines. By continuing to examine the efficacy and safety of available therapies, clinical research can establish if other patient populations could benefit from their use and inform clinical decision making with improved understanding of their risk-benefit profiles.

By engaging directly with the AD research community, policymakers can put in place infrastructure changes to speed up timelines and achieve more streamlined collaboration. The momentum of 2024’s clinical advancements have opened an exciting window of opportunity. With dedicated funding support and a greater focus on increasing the number of AD-specific clinical trials, policymakers can help translate today’s research into tomorrow’s treatment.

“While the landscape of clinical research in AD is incredibly exciting, we also need to see policy and healthcare systems evolve in parallel. ADI has actively advocated for policy makers to prepare for the possibility of new treatments for over a decade. Without similar progress in these areas, we cannot realize the true value of the new innovations that science can deliver” remarked Paola Barbarino, Chief Executive, Alzheimer’s Disease International.