Fujifilm’s T-817MA drug has not met its primary study endpoints of cognition or global clinical function in its US Phase II clinical trial conducted on patients with mild to moderate Alzheimer’s disease.
There were no significant differences in secondary outcomes. In exploratory analyses, 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.
Post hoc analyses also suggested T-817MA treatment with shorter duration of illness and symptoms was associated with better cognitive outcomes with statistical significance. Fujifilm is to review the results of the Phase II clinical trial with regulatory authorities including FDA (US Food and Drug Administration) and “will take necessary steps toward further development including Phase III clinical trial of this compound,” according to a company release.
A pre-clinical research, led by Rudolph Tanzi, Joseph P and Rose F Kennedy professor of Neurology at Harvard Medical School, , and vice-chair of Neurology at Massachusetts General Hospital (both Boston, USA), revealed that T-817MA acts on microglia that have a risk gene for AD and promotes the clearance of amyloid-β (Aβ).
These results suggest that T-817MA may act on p-Tau and Aβ, major causal substances in Alzheimer’s disease.