Meet This Largely Over-Looked Phase 3 Alzheimer's Company

January 31, 2017
By Alex Keown, BioSpace.com Breaking News Staff

BOULDER, Colo. – Biogen and Eli Lilly have dominated recent headlines surrounding the pursuit of a treatment for Alzheimer’s disease. But, one company has quietly made its way to a Phase III trial in developing a therapy for Alzheimer’s—Accera, Inc.

This morning, MedCity News highlighted the work done by Colorado-based Accera and its lead therapy, AC-1204, a ketosis-inducing compound. According to company information, AC-1204 generates ketones that have the potential to restore the supply of adenosine triphosphates, which improves neuronal metabolism and cognition in patients with mild to moderate Alzheimer’s disease.

Data from the Phase IIb study showed a significant improvement compared to placebo of greater than 3 points in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) in patients with mild to moderate Alzheimer's disease who did not carry the epsilon 4 variant of the apolipoprotein E gene (APOE4), the company said last year.

Accera has quietly moved AC-1204 through multiple trials, which drew the attention of Nestle, which has invested hundreds of millions into the research, MedCity News said. While Biogen and Eli Lilly therapies attacked amyloid plaque associated with Alzheimer’s disease, Accera approaches the potential treatment as a metabolic condition. Accera Chief Executive Officer Charles Stacey told MedCity News that literature shows metabolic issues arise in Alzheimer’s patients decades before symptoms of the neurodegenerative disease appears. Stacey said if the cells cannot process glucose, they become starved, which leads to cell death and the potential trigger of amyloid-beta deposits. MedCity News said some researchers have likened Alzheimer’s disease to “type 3 diabetes,” which suggests the “metabolic deficits in the brain are the result of an insulin deficiency or resistance.”

The ketones that AC-1204 generates are like those generated in the liver when glucose is in short supply. AC-1204 has two planned Phase III trials, with the second planned for later this year. Enrollment for the first late-stage trial was completed in May.

According to the company website, Accera hopes to submit the drug for approval by 2020.

Finding a cure for Alzheimer’s disease has been difficult to say the least. In late November, Indianapolis-based Eli Lilly announced recent failure of solanezumab, the drug the company hoped would be the answer to Alzheimer’s disease. The Phase III failure marked the second time solanezumab failed in a late-stage Alzheimer’s trial. The last time was in 2012, but for this go-round, Eli Lilly opted to use the drug to focus on milder-forms of Alzheimer’s and using a “delayed start” method. However, Phase III data showed that solanezumab failed to show a statistical slowing in cognitive decline compared to placebo.

In contrast, Biogen investors breathed a sigh of relief on positive news for aducanumab, the company’s experimental drug targeting amyloid plaque in the treatment of Alzheimer’s disease. While the Phase Ib trial was positive, late-stage data will not be available for a few years.