EXCLUSIVE: AgeneBio CEO Says Delays in Alzheimer's Onset Could Save Millions, As Paradigm Shifts

EXCLUSIVE: AgeneBio CEO Says Delays in Alzheimer's Onset Could Save Millions, As Paradigm Shifts
March 11, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Recent data published by the National Institutes on Aging show that modest delays in the onset of Alzheimer’s related dementia have massive benefits to patients, their families and society as a whole, the CEO of a company creating a new drug for the disease told BioSpace , and scientists should focus more on this important link.

Jerry McLaughlin, president and chief executive officer of AgeneBio, told BioSpace that the treatment of Alzheimer’s those far has been focused mostly on palliative care for patients, but now that new research has shown delays in symptoms can greatly relieve a patient and their family’s emotional and financial burdens, science has a new lead to follow.

Existing treatments are limited to providing temporary symptomatic relief once a patient has already advanced to Alzheimer’s dementia. “The problem is that by the time patients experience Alzheimer’s dementia, brain cell death is too substantial to have a meaningful impact on disease progression,” McLaughlin told BioSpace.

“Additionally, most clinical programs have targeted plaques that are present in the brains of patients with Alzheimer’s disease,” he said. To date, billions of dollars and many years have been spent on trials targeting plaques and “all have failed to work.” The challenge, said McLaughlin, is that a substantial percentage of patients with plaques never develop Alzheimer’s disease.

“For every year delay in the onset of Alzheimer’s dementia, there is an approximately 10% reduction in the prevalence of this disease, with most advancing to Alzheimer’s dementia within seven years,” McLaughlin told BioSpace. “This could have an enormous impact on Medicare and Medicaid costs for Alzheimer’s, which are currently $150 billion in direct medical costs with the annual cost expected to exceed $1 trillion by 2050.”

As such, AgeneBio is focused on addressing hippocampal over activity in aMCI, the pre-dementia phase of Alzheimer's. Research both at Johns Hopkins University and elsewhere shows that hippocampal over activity in aMCI is the best predictor of progression to Alzheimer's, and addressing this over activity may be the key to delaying Alzheimer's dementia.

“The most exciting part of this new approach is the recognition that the condition we are targeting, hippocampal over activity in aMCI (the pre-dementia stage of Alzheimer’s) greatly elevates the risk of progression to Alzheimer’s dementia, and there are absolutely no treatments available today.

In a recent Phase II trial, the company’s lead drug candidate, AGB101, restored brain network function and significantly improved memory in elderly patients with aMCI. These results are consistent with preclinical work, and AgeneBio expects Phase III to initiate in second half of this year, McLaughlin told BioSpace.

If approved, AGB101 will be the first and only therapeutic that reduces hippocampus over activity and could be the first therapeutic to slow progression to, and delay the onset of, Alzheimer’s dementia. Hippocampal over activity is the defining symptom and best predictor of memory loss and ultimate progression to Alzheimer’s dementia.

“There is nothing that can be done today to deter progression; sadly, it’s just watchful waiting until the patient progresses to Alzheimer’s dementia,” said McLaughlin, who said the company has “strong” Phase II data and an upcoming Phase III trial of AGB101 to further validate this approach.

“Pending positive clinical trial results and [U.S. Food and Drug Administration (FDA)] approval, we believe AGB101 will offer patients with aMCI the opportunity to preserve memory and cognitive abilities and the potential to slow progression to and delay the onset of Alzheimer’s dementia,” he said.

BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?

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