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21 August, 2020

Ally Bridge Portfolio News – Biotechs Tap Growing U.S. Government Support for Alzheimer’s Research

Federal funding for dementia and Alzheimer’s studies has surged, as venture funding focuses on other diseases

Aug 20, 2020 Wall Street Journal

Alzheon Inc. will be holding Phase 3 clinical trials of its oral drug ALZ-801 after receiving $47 million from the National Institute on Aging, part of the National Institutes of Health.

Biotechnology companies are capitalizing on a growing federal effort to fund dementia research to develop new medications for Alzheimer’s disease, filling a gap in venture funding compared with investments to fight other diseases.
Startups such as Alzheon Inc. and Cognition Therapeutics Inc. recently won grants from the National Institute on Aging, part of the National Institutes of Health, to finance clinical trials of medicines for Alzheimer’s, the most common cause of dementia. Current medicines treat Alzheimer’s symptoms, but not the disease itself.
Government funding for dementia has surged since the passage of a federal law, the National Alzheimer’s Project Act, in 2011, which led to a goal to develop effective treatments by 2025. Last year, Congress awarded an additional $350 million to the NIH for Alzheimer’s and dementia research, giving it $2.8 billion to devote to this area, a more than six-fold increase since 2011.
Grants reduce startups’ need for venture capital, which has been harder to come by for Alzheimer’s, an area where drugmakers have struggled, than in fields such as cancer where they have had more success. Venture funding for U.S. startups with lead drug programs for Alzheimer’s was 16 times below that for those focused on cancer in the period from 2008 to 2017, said a 2019 report by the Biotechnology Innovation Organization, an industry group.
But some investors and researchers say they see promise in new treatments researchers are developing for the disease, which affects 5.8 million Americans aged 65 and older, according to the nonprofit Alzheimer’s Association.
“This field would not progress at the current rate without the government support,” said David Dolby, chief executive of Dolby Family Ventures, an investor in Cognition and other Alzheimer’s drugmakers.
Annual NIH funding for dementia research stood at about $450 million a year in 2011 and the years leading up to it, but funding bumped up after passage of the Alzheimer’s Project Act. It further increased with the Alzheimer’s Accountability Act in 2015, which required NIH scientists to submit annual budget proposals for funds needed to reach the
goal of effectively treating Alzheimer’s by 2025, according to Rachel Conant, vice president of federal affairs for the Alzheimer’s Association.One drug that could meet that goal is aducanumab, from Biogen Inc. and partner Eisai Co., which could be the first therapy to slow the decline in patients’ ability to think and function. In July, Biogen filed for U.S. Food and Drug Administration approval of the drug.
Experts, however, say a number of therapies will be needed to combat the condition across the Alzheimer’s population.
“We need to have many, many more shots at goals, we don’t have nearly the number of projects in Alzheimer’s disease as in cancer,” said Anton Porsteinsson, director of the
University of Rochester Alzheimer’s Disease Care, Research and Education Program, and a scientific adviser to Alzheon.
Framingham, Mass.-based Alzheon has won a $47 million award from the National Institute on Aging to conduct Phase 3 clinical trials of an oral drug, ALZ-801, which blocks the formation of brain proteins known as soluble amyloid oligomers. Soluble oligomers trigger harmful effects on the cognitive abilities of people with early Alzheimer’s, according to the company.
Alzheon plans to study the drug in 300 patients who have two copies of a gene called APOE4, a population at higher risk for rapid progression of the disease. It expects these studies to begin early next year. If all goes well, Alzheon could file for FDA approval in 2023 or 2024, Chief Executive Martin Tolar said. Alzheon’s venture backers include Ally Bridge Group.
New York-based Cognition in June said it won a grant that will total $75.8 million over five years to support a 540-patient Phase 2 trial of its lead drug, CT1812, in patients with early Alzheimer’s disease. CT1812 is an oral medication that could normalize protein-trafficking and lipid-metabolism processes that are disrupted in Alzheimer’s patients, according to the company.
Generally, federal funding increases have helped scientists pursue a wider range of new tactics for battling dementia, said Rebecca Edelmayer, director for research engagement at the Alzheimer’s Association.
“The progress we make in Alzheimer’s is going to be proportionate to our investment,” Dr. Edelmayer said.

https://www.wsj.com/articles/biotechs-tap-growing-u-s-government-support-for-alzheimers-research-11597917600

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