Nonprofits and the Federal Government Outperforming the Pharmaceutical Industry to Lead the Development of Alzheimer’s Drugs
Two articles published online today by Alzheimer’s and dementia: translational research and clinical interventions, a review by the Alzheimer’s Association, show substantial changes in the direction and funding of clinical trials for Alzheimer’s disease therapies. The recently published articles further shed light on a decision – now before the United States Food and Drug Administration (FDA) – that would potentially bring a new drug treatment to Alzheimer’s patients for the first time in nearly 20 years. years.
Researchers analyzed Clinicaltrials.gov, the US National Library of Medicine database, and five years of annual reviews of the Alzheimer’s pipeline published by Jeffrey L. Cummings, research professor in the School of Health Sciences. of UNLV, and his colleagues. The results illustrate the pharmaceutical industry’s high-profile withdrawal from Alzheimer’s disease clinical trials, particularly early-phase human trials, and the emergence of federal agencies and nonprofits. as the main engines of growth and innovation.
In the first study, “Who is funding Alzheimer’s drug development?” Cummings and colleagues found that the number of Alzheimer’s disease clinical trials supported by pharmaceutical companies has declined over the years. past five years, while trials supported by federal government sources and public-private partnerships (P3s) have increased. The authors observe that pharmaceutical companies do not increase their involvement in Alzheimer’s disease trials and drug development except through PPP, which allows them to spread costs and risks. And they largely only engage in late stage clinical trials (phase 3).
Researchers have found that the testing gap is increasingly being addressed by academic medical centers (AMCs). AMC trials have increased 78% over the past five years, primarily funded by the U.S. National Institutes of Health (NIH) and the National Institute on Aging (NIA), Alzheimer’s Association and Alzheimer’s Association programs. the Alzheimer’s Drug Discovery Foundation (ADDF), including the Part The Cloud initiative of the Alzheimer’s Association.
“Nonprofit organizations and the NIH are making a huge difference in the development of drugs for Alzheimer’s disease and all other dementias,” Cummings said. “The past few years have been a period of pharmaceutical downsizing after multiple negative clinical trials, but also a period of innovation in early trials and re-evaluation of previously underfunded ideas. in clinical trials, therapeutic mechanisms are more diverse, biomarkers are used more regularly, and reused agents are explored – increasingly led by academic researchers and funded by the NIH, Alzheimer’s Association and ADDF.
A second article, “Alzheimer’s Disease Drug Development Pipeline: 2021,” also by Cummings and colleagues, including a student, Justin Bauzon, of the UNLV School of Medicine, reinforces these trends by showing that despite the withdrawal from pharma of Alzheimer’s disease, the total number of agents in Alzheimer’s disease clinical trials has been relatively stable over the past five years. The total is up slightly from 2020, thanks to additional agents in phase 2 studies. There is also an increasing diversity of drug targets and therapeutic mechanisms in the Alzheimer’s pipeline, thanks to innovative phase 1 trials. and 2.
“Alzheimer’s Association funding, partnerships – including the NIA and ADDF – and advocacy for federal funding for Alzheimer’s disease research are now the main drivers of the growth of clinical trials on Alzheimer’s disease. Alzheimer’s disease, filling the void left by retirement from the pharmaceutical industry and developing and diversifying the initial drug product pipeline, ”said Maria C. Carrillo, Scientific Director of the Alzheimer’s Association.
The NIA now distributes more than $ 3 billion a year for Alzheimer’s disease and dementia research, up from $ 500 million just a few years ago. “This great victory is almost entirely due to the legislative efforts of the Alzheimer’s Association, our grassroots advocates and our champions in Congress,” Carrillo said.
The FDA is currently reviewing aducanumab (Biogen) for the treatment of Alzheimer’s disease. A decision is expected on June 7.
“If pharmaceutical companies don’t see a clear path to FDA approval, they will continue to not invest in Alzheimer’s disease,” Cummings said. “This further underscores the importance of the decision before the FDA at this time.”
There are four drugs approved and commonly used to treat the symptoms of Alzheimer’s dementia, as well as a combination therapy that includes two of these drugs. There is currently no approved drug that modifies the course or delays the progression of the disease or that delays or stops the clinical decline. No new drugs have been approved for Alzheimer’s disease since 2003.
The authors of the article say, “If new therapies are approved by regulatory authorities, more sponsors and more funding could be attracted to Alzheimer’s research through accelerated innovation.”
Both studies were supported by the Chambers-Grundy Center for Transformative Neuroscience at UNLV, dedicated to advancing clinical trial methods to deliver better treatments to patients faster.
UNLV Program Brain Health Department
The UNLV Brain Health Department was launched by the School of Integrated Health Sciences (SIHS) in 2019 to advance research, education and practice for the benefit of brain health and human health. care and treatment of people with brain disorders. The faculty of the department specializes in basic and clinical research in neurodegenerative diseases, neuropsychology and occupational therapy.
Alzheimer’s and dementia: translational research and clinical interventions (TRCI)
Alzheimer’s and dementia: TRCI is an open-access, peer-reviewed journal of the Alzheimer’s Association that connects all of the explorations between basic research, drug discovery and clinical studies in Alzheimer’s disease and dementia. The journal publishes findings from multi-faceted research areas and disciplines to accelerate what is learned on the bench and translated and applied at the bedside.
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