Japan’s Fujifilm sees phase 2 flop for Alzheimer’s candidate

The company missed its endpoints, but is keen to push on into a possible phase 3

In an all-too-familiar press release, Fujifilm announced this morning that it has become the latest in a long line of biopharmas to see a failure for its Alzheimer’s drug.

The phase 2 test of T-817MA, which is believed to have a neuroprotective effect by promoting neurite outgrowth through the activation of sigma receptors, missed its primary study endpoints of cognition and/or global clinical function. It added that there “were no significant differences in secondary outcomes,” either. So, a big flop.

But the Tokyo, Japan-based company isn’t giving up, saying in a statement that it “will take necessary steps toward further development, including phase 3 clinical trial of this compound.” It also said it would likely seek out a partner.

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Digging into the data, the company tried to find the positives, and said that 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.”

It added that post hoc analyses also suggested that treatment with shorter duration of illness and symptoms “was associated with better cognitive outcomes with statistical significance.”

It concludes that these results “suggest that T-817MA may act on p-Tau and amyloid beta,” the current theories behind the causal factor in Alzheimer’s. These have not as yet translated as success in the clinic, however, with a series of failures coming over the past decade.

RELATED: Alzheimer’s biotech Alzheon to move once-failed drug into new PhIII

Its shares were down 1% this morning on the news.

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