”The growing health and financial impact of Alzheimer’s disease on American patients, caregivers, and our healthcare system makes the need for new treatments more pressing each day,” said BIO President and CEO
The analysis, which aims to assess the depth and breadth of innovation to meet the needs of patients suffering from Alzheimer’s disease, also features historical clinical success rates, failed mechanistic strategies, as well as trends in venture financing and investment into new clinical trials.
- Lack of Approved Drugs: There are currently no FDA-approved disease-modifying drugs for Alzheimer’s disease.
Insufficient Venture Investment: Venture capital funding of U.S.companies with lead programs in Alzheimer’s disease is 16 times below oncology funding ( $1.0 billionvs. $16.5 billionover the last decade).
- Poor R&D Success Rates: Clinical development success for disease-modifying drug programs for Alzheimer’s has been difficult in late-stage trials, with no disease-modifying drugs moving beyond Phase III to FDA filing. Since 2008, a total of 87 clinical-stage disease-modifying programs have been suspended.
- Inconsistent Clinical Trial Initiations: Clinical trial starts for disease-modifying Alzheimer’s drugs have ranged from 11-21 trial starts per year since 2008, with no detectable trend. Phase III trial starts have been the least consistent, ranging from 0-5 per year.
- Growing & Diverse R&D Pipeline: There are 74 clinical-stage programs with disease-modifying potential in Alzheimer’s disease. The drug candidates in these programs are attempting to stop, prevent, or slow the progression of Alzheimer’s disease using 10 different strategies involving 30 distinct molecular targets. Small biotech companies account for more than three-fourths of these clinical programs.
“With a 100% failure rate for disease-modifying Alzheimer’s Phase III studies, this has been the most challenging R&D hurdle in our industry. The combination of a looming crisis in Alzheimer’s-associated healthcare costs and no disease-modifying drug on the market indicates a desperate need for higher levels of investment and innovative approaches,” said report author
The report and other BIO Industry Analysis reports are available for download here: www.bio.org/iareports.
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