The annual pipeline report, published May 25 in Alzheimer’s & Dementia: Translational Research and Clinical Interventions, a journal of the Alzheimer’s Association, is led by Dr. Jeffrey Cummings, a leading Alzheimer’s clinician-scientist and research professor in UNLV’s School of Integrated Health Sciences. The goal of the annual report, Dr. Cummings says, is to spot trends in clinical trial design and outcome measures, and also investigate the types of agents and biological targets that are being pursued. According to the “Alzheimer’s Disease Drug Development Pipeline: 2023,” there are currently 187 clinical trials in the Alzheimer’s drug development pipeline – the most ever on record. - 187 current trials, which consist of 141 unique treatments - just off last year’s record of 143 unique treatments
- 58 new drugs have entered the pipeline in the past year
- DMTs are the most common agents used in trials: 111 agents, or 79%, of the total number of drugs in the pipeline
- 28% of candidate therapies are repurposed from other diseases
- 57,465 participants are needed for all currently active trials
"We are at an inflection point in the Alzheimer's field. The recent landmark FDA approvals we've seen for both disease-modifying and symptomatic treatments, as well as the diversification of the pipeline of potential new Alzheimer's therapies, provide hope to those impacted by this devastating disease," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer. "Yet, Medicare stubbornly continues to block access for people who could benefit."
Biologics Gaining Momentum
Cummings notes that the use of biologic therapies - particularly monoclonal antibodies - has become increasingly popular. Among DMTs, related trials have risen more than 10% over the past year (44% of drugs in the pipeline). These therapies are mainly given by IV infusion, as opposed to small molecule therapies (56% of DMTs in the pipeline) that can be taken orally.
“The recent approval of two anti-amyloid monoclonal antibodies specifically for Alzheimer’s is certainly influencing the pipeline, but these are complex therapies,” Cummings said. “We’re in a steep learning period for how we incorporate these advances into care. They require intense resources and regular MRI scans during the initial phase, which can lead to unprecedented demands on health care systems.”
In addition to the growth of biological therapies aimed at amyloid and tau – two hallmark signs of Alzheimer’s disease in the brain – Cummings anticipates more investment in small molecules aimed at amyloid. The use of biomarkers has also become more prevalent in clinical trials, particularly in DMT trials, and their foundational role in drug development has been shown to increase probability of success throughout the pipeline.
Pharma Investment Growing
After a recent decline, the pharma industry has also started to become more of a player in clinical trials. Of all the trials in development, 108 (58%) are industry sponsored, up nearly 8% over the past year. Public-private partnerships accounted for 9% of trials, and 32% were funded by academic medical centers - a group that includes the NIH, universities, advocacy groups, and related organizations.
“We see many more phase 1 biologics than agents in any other therapeutic class, which again reflects an increased enthusiasm of pharma for biological agents such as monoclonal antibodies,” said Cummings. “Overall, the recession has impacted biotech investment, but I expect to see the Alzheimer’s investment arena rebound with the economy, which will drive investment compared to previous years when the capital becomes available.”
Alzheimer’s drug development pipeline: promis | EurekAlert!