Published on: June 26, 2017
by Bevin Fletcher for Bioscience Technology:
There is an urgent need to ramp up the number of therapies entering the Alzheimer’s disease pipeline, according the Cleveland Clinic’s second annual analysis of Alzheimer’s disease drug development.
If changes aren’t made, the U.S. goal of bringing a meaningful therapy to patients by 2025 is in danger of not being met, according to the authors.
The analysis, which is based on the federal website ClinicalTrials.Gov, found that the drug pipeline is small, with only 105 agents in the pipeline, and only eight new therapies entering Phase 1 trials since 2016. Compared to the 2016 pipeline, there are 16 new agents in Phase 2 trials and five in Phase 3.
Of the drugs in the pipeline, 70 percent are disease-modifying therapies, 14 percent are symptomatic cognitive enhancers, and 13 percent are symptomatic agents addressing neuropsychiatric and behavioral changes.
Jeffrey Cummings, M.D., director of Cleveland Clinic Lou Ruvo Center for Brain health and colleagues determined that a drug must be in Phase 2 of a trial in order to be approved by 2025. There are currently 52 Alzheimer’s disease agents in Phase 2 trials, so while there are a number of therapies in the pipeline that could be approved in that timeline, the authors noted that given the 99.6 percent drug failure rate, the ability to have a supply of therapies that can respond to the growing Alzheimer’s population is far from guaranteed.
It’s estimated that 100 million people around the globe will be affected by Alzheimer’s by 2050, and the total cost of the disease in the U.S. is expected to reach $1 trillion.
The authors outlined a number of obstacles to Alzheimer’s disease development, including slow and expensive clinical trial recruitment, a high rate of drug failures, and insufficient funding.
The largest barrier to drug development is the slow recruitment of patients to participate in clinical trials, according to the analysis. A national effort is needed to address this issue, the authors said, as the number of participants needed is large, with a total of 54,073 people needed to complete current Phase 1, 2, and 3 trials combined.
Utilizing biomarkers to find people that would qualify for clinical trials could speed up the recruitment process, the authors suggest. They also note that repurposing FDA-approved drugs for other conditions could expedite the drug development timeline.
New therapies need to prevent, defer or slow the decline of Alzheimer’s are also in high need, as it’s estimated that the overall frequency of the disease could decrease by nearly 50 percent if the onset of Alzheimer’s could be delayed by five years, according to the report.
Investing in basic research is one recommendation that the authors say will help identify more targets and candidate compounds, as well as funding for translational research to help support clinical trials and improve trial methods.
Biopharma companies sponsor 65.5 percent of all clinical trials and are currently the major economic force for drug development, however the finical instruments in place are not sufficient to respond to the urgent need, the authors write. New investment vehicles are needed, they conclude, including private-federal bonds, and new types of collaborations, such as between the National Institutes of health and biopharma companies, and consortia. They also suggest that Medicare and insurance companies who would benefit from improved health of older patients should be engaged in funding conversations.
“The need is great, the challenges many, the rewards high: this is the condition of AD drug development,” the researchers wrote.
The paper was reported in Alzheimer’s & Dementia: Translational Research & Clinical Trials Interventions.
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