FUJIFILM Corp. Announces Results from Phase II Clinical Trial of "T-817MA" in Patients with Alzheimer's Disease in the United...
2017年7月19日 - 5:30PM
ビジネスワイヤ(英語)
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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For enquiries on information in this media release,
contact:Media contactFUJIFILM CorporationKana Matsumoto, +81
3-6271-2000Corporate Communications DivisionOtherFUJIFILM
CorporationPharmaceutical Products DivisionTEL +81 3-6271-2171