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Another Alzheimer's Let-Down as FUJIFILM's Candidate Flunks Phase II Test

7/19/2017 7:53:18 AM

Another Alzheimer's Let-Down as FUJIFILM's Candidate Flunks Phase II Test July 19, 2017
By Alex Keown, Breaking News Staff

TOKYO – Another Alzheimer’s disease treatment has failed to meet its goals in clinical trials. This morning Fujifilm Corporation announced its experimental Alzheimer’s disease treatment T-817MA did not meet primary endpoints in a Phase II trial.

The Japanese company and its subsidiary Toyama Chemical, the developer of T-817MA, is now among the growing list of companies that have failed to reach the golden ring of developing a treatment for the dreaded neurological disease. Despite that failure, Fujifilm said it is still looking at the possibility of pushing T-817MA into a Phase III study.

This morning, Japan-based Fujifilm Corporation said T-817MA did not meet its primary study endpoints of cognition or global clinical function in its Phase II clinical trial of patients with mild to moderate Alzheimer’s disease. The study also showed no significant differences in secondary outcomes, the company said in its statement.

While the drug candidate failed to meet trial endpoints, Fujifilm pointed to some potential promise in a key biomarker for tau in a higher dose treatment, which is why it will continue to develop the drug. The company said exploratory analyses indicated that “change of the cerebrospinal fluid (CSF) biomarker phospho-tau (p-Tau) benefited from the higher dose treatment while hippocampal volumes decreased less in the lower doses group with statistical significance.” Fujifilm researchers are exploring the idea of brain tangles, which are twisted tau proteins that cause brain cells to die. Fujifilm said progression of Alzheimer’s disease is associated with these tangles “caused by hyperphosphorylation and fibrillization of tau proteins.”

Additionally, Fujifilm said analyses suggested that T-817MA treatment with shorter duration of illness and symptoms was associated with better cognitive outcomes with statistical significance.
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Those analyses are why the company said it will meet with the U.S. Food and Drug Administration to determine a way to move forward into a Phase III trial for the drug. Fujifilm did say it was also interested in pursuing potential partnerships to further develop the experimental drug. There is certainly precedent for adjusting trial parameters after a failure and moving forward with additional studies. For example in 2014, Genentech (RHHBY)’s Alzheimer's therapy crenezumab, an anti-Abeta antibody, failed to meet endpoints in a Phase II study of Alzheimer’s patients. But, after looking at parameters, the company moved forward with additional testing. Like many other Alzheimer’s researchers, Fujifilm believes it has learned something from the failure that can be harnessed into another shot on goal.

Pre-clinical showed that T-817MA acts on microglia that have a risk gene for Alzheimer’s disease and promotes the clearance of amyloid-ß (Aß). These results suggest that T-817MA may act on p-Tau and Aß, major causal substances in Alzheimer’s, the company said.

Alzheimer's disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total, there are about 50 million people suffering from some form of dementia worldwide. The Alzheimer’s drugs that have reached the market have only been successful in temporarily slowing the disease for up to a year.

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