'We were trying to build the plane at the same time as flying it,' says Biogen on Alzheimer's research

By Maggie Lynch

- Last updated on GMT

(Image: Getty/sudok1)
(Image: Getty/sudok1)

Related tags Alzheimer's disease Alzheimer Dementia Developmental biology phase I

Previous setbacks in Alzheimer’s disease research for disease-modifying treatments have set the stage for a pipeline of new medicines now moving into clinical trials, according to a recent PhRMA report.

Currently, 92 new medicines are in clinical development to treat Alzheimer’s disease (AD), according to the report by the Pharmaceutical Research and Manufacturers of America (PhRMA​).

Seventy-five percent of the drugs in Phase II or III are potentially disease modifying, aiming to delay the onset of the degenerative disease – potentially up to five years in some patients.

AD is the sixth leading cause of death in the US and 5.7m Americans are affected by the disease. The rate of Alzheimer’s is believed to increase to up to 13.8m Americans by 2050.

Today, AD accrues $277bn each year in medical costs and one in every five Medicare dollars goes towards the treatment and care of individuals with AD. An increase in Alzheimer’s will raise the direct cost of the disease to $1.1tn in 2050, according to the report.

However, the development of a disease-modifying treatment could save an estimated $367bn by 2050, through treatment that may delay the onset of AD.

Between 1998 and 2017, 146 investigational medicines in clinical development have been suspended or put on hold and have not received regulatory approval, according to the Adis R&D Insight database​. But researchers state that setbacks are both inevitable and beneficial.

PhRMA, Researching Alzheimer’s Medicines: Setbacks and Stepping Stones, September 2018
PhRMA, Researching Alzheimer’s Medicines: Setbacks and Stepping Stones, September 2018

Samantha Budd Haeberlein, VP of Alzheimer’s late-stage clinical development of Biogen, told us that the difficulties in developing drugs in the past were due to a lack of knowledge.

“We were trying to build the plane at the same time as flying it,” ​she said earlier this month at a media briefing covering the report.

“Not knowing as much about the disease, we weren’t addressing the right targets, we weren’t handling the best molecules to address those targets,” ​added Budd Haeberlein.  

Today, a new pipeline of 92 treatments currently being developed by biopharmaceutical companies could potentially slow the progression of the disease by targeting beta-amyloid plaques, tau protein tangles, and a receptor that decreases the neurotransmitter necessary for proper brain function.

Doug Williamson chief medical officer and vice president of US medical at Lundbeck stated, “If you look at the portfolio of trials the majority of treatment in development as we’ve talked about are in the disease-modifying areas.”

Budd Haeberlein further explained that knowing more about what molecules to target has allowed for greater understanding, but also has led to the need to conduct trials in the correct patients​. “We need to be going to patients before we see these symptoms. Today’s clinical [trials] need to be in patients in much earlier stages,” ​she said.

According to the Alzheimer’s Association​ that there are more than 400 Alzheimer’s studies recruiting​ on ClinicalTrials.gov with roughly 50,000 volunteers needed.

“It is not just the volume of treatments in development that’s important, but it’s the diversity and breadth of treatments in the pipeline,” ​noted Williamson.

Jason Resendez, chief of staff at UsAgainstAlzheimers and executive director of LatinosAgainstAlzheimer’s Coalition, also explained that there’s been an increase in federal funding for Alzheimer’s, increasing to $2.34bn in the financial year of 2019​.

“We’re finally getting the right folks at the table to address this,” ​Resendez said, adding that AARP also has made a $60m investment to the Dementia Discovery Fund (DDF).

Resendez said, “I’m very optimistic that within ten years we’ll have a breakthrough and the current generation of Alzheimer’s sufferers will be the last generation of sufferers that have to go through this."

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