FUJIFILM Corporation Announces Results from Phase II Clinical Trial of "T-817MA" in Patients with Alzheimer's Disease in the United States

FUJIFILM Corporation (TOKYO: 4901) (President: Kenji Sukeno) announced that the company’s Alzheimer’s Disease drug “T-817MA,” did not meet its primary study endpoints of cognition or global clinical function in its Phase II clinical trial conducted in the United States on patients with mild to moderate Alzheimer’s Disease (AD). 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*¹ 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 will review the results of the Phase II clinical trial with regulatory authorities including FDA (U.S. Food and Drug Administration) and will take necessary steps toward further development including Phase III clinical trial of this compound.

A pre-clinical research, led by Dr. Rudolph Tanzi, Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard Medical School, and Vice-Chair of Neurology at Massachusetts General Hospital, revealed that T-817MA acts on microglia*² 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 AD.

AD’s main symptoms are abnormalities in cognitive functions, including memory. It is believed that abnormality of neurological functions in AD manifests as a result of Aβ protein deposits (senile plaques) in the brain. The progression of the disease has strong association with the formation of abnormal assemblies caused by hyperphosphorylation and fibrillization of tau proteins, found in the axons of nerve cells (neurofibrillary tangle), synapse*³ loss and atrophy of the brain including hippocampus.
The number of people suffering from dementia is estimated to be 44 million around the world. The number is projected to increase to 76 million by 2030 with the aging of the world population. Over half of these dementia cases suffer from AD, and the trend is set to continue.
AD drugs currently available on the market include acetylcholinesterase inhibitors, such as donepezil hydrochloride. As these drugs address the deficit in neurotransmission to give temporary improvement to the patients' symptoms, there is an unmet need for a new class of therapies to treat AD.

T-817MA is an AD drug discovered by the Fujifilm Group company, Toyama Chemical. It has potent neuroprotective effect and promotes neurite outgrowth through the activation of sigma receptors*⁴, demonstrating strong efficacy in animal models.　Fujifilm is committed to further accelerating the development of T-817MA under possible partnerships, and contributing to resolving social challenges through the delivery of innovative pharmaceutical products.

	*1		Hippocampus is a region of the cerebrum, associated with memory. AD causes neuronal loss, which results in hippocampal atrophy.
	*2		Microglia are a type of glia cells, which are component of the central nervous system. Microglia provide immune defense in the brain, while also being involved in repairing abnormal neural cells, and eliminating the aggregated Aβ. At the same time, excessively activated microglia are known to play a role in neuro-degeneration in the central nervous system.
	*3		Synapse is a structure connecting neurons, allowing them to pass electrical signals to convey information between them.
	*4		Sigma receptors are protein that exists on the membrane of endoplasmic reticulum in cells, and have the function of mitigating neuro-degeneration in the central nervous system.

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