Axona is mentioned in this thread and many others, so thought I'd put this here.
MANAGEMENT, STRATEGY SHIFT FOR ACCERA
CEO appointed to advance Alzheimer’s drug trials
By Alicia Wallace The Denver Post
The U.S. Food and Drug Administration has granted approval for only five drugs to treat the symptoms of Alzheimer’s disease.
Broomfield-based Accera Inc. wants to develop the sixth and this week named a new CEO to lead the charge.
Dr. Charles Stacey, a former surgeon and neuroscience researcher, has been named president and CEO of the privately held firm. Stacey joined the company in February on an interim basis, coming from Inventages, a life sciences-focused venture capital firm that joined companies including Nestlé in investing in Accera.
Stacey’s appointment headlines a shift in management and strategy for Accera, which previously gained mixed reaction — and, eventually, an FDA warning letter — for its Axona “milkshake,” a medical food to improve cognitive functions in patients suffering from mild to moderate symptoms of Alzheimer’s. Accera now is focused exclusively on advancing a new therapy, AC-1204, through the regulatory process, Stacey said. Accera currently is enrolling for late-stage clinical trials related to AC-1204.
“Essentially, a little company in Colorado is one of a handful of companies in the world in Phase 3” clinical trials for an Alzheimer’s drug, he said.
One of the indicators of Alzheimer’s is the brain’s inability to metabolize glucose as a fuel. AC-1204, which also is mixed in food, aims to boost ketone levels in the brain as an alternative fuel. It is a different formulation, but has a goal similar to Axona.
The Alzheimer’s Association and some physicians in the field have warned against medical foods such as Axona and other alternative treatments. Claims for those treatments often are based on a small body of scientific research and are not subject to rigorous regulatory procedures, the association said.
Stacey said the company stands behind the studies of Axona, but Accera now is focused on advancing a therapy through the FDA’s channels.
If AC-1204 is successful in its clinical trials and regulatory reviews, FDA approval could come after 2020 or 2021.
“There are a graveyard of products out there that address this target and have failed,” Stacey said. “The industry as a whole is really looking for other mechanisms.”
Between 2002 and 2012, 244 Alzheimer’s drugs went through clinical trials, according to the Alzheimer’s Association. Of those, only the drug Namenda received FDA approval.
About 65,000 people in Colorado who are older than 65 are living with Alzheimer’s, according to the Colorado Chapter of the Alzheimer’s Association. That number is expected to grow to 92,000 by 2025.
“Certainly, we are very excited about all aspects of research and movement toward ultimately finding a cure,” said Khristine Rogers, vice president of communications for the local chapter.