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20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
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Figure 17: Blaze High Dose ARM: Amyloid PET Results

 

 

Ref: Honigberg, et. al., CTAD 2014 

 

The BLAZE biomarker study high-dose intravenous cohort showed a consistent trend of reduced Abeta accumulation in the brain over time shown by two independent exploratory analyses of florbetapir-PET data. Using white matter rather than cerebellum as the key reference region in the brain is generally considered a more robust method of showing treatment effects of AD therapies.

 

In the BLAZE study, patients also showed a statistically significant increase in CSF Abeta1–42, which we believe confirms target engagement by crenezumab. Similar results were observed in the ABBY study where CSF Abeta 1-42 level was assessed in 49 patients. These results suggest that Abeta is being eliminated from the brain when treated with crenezumab.

 

Figure 18: BLAZE High Dose Arm: Crenezumab increases CSF total Abeta levels relative to placebo

 

 

Ref: Honigberg, et. al., CTAD 2014 

 

BLAZE Study Results: Effects on Cognition and Global Function

 

A similar and consistent pattern of response was observed in the BLAZE study with slowing of loss of cognition compared to placebo observed at the high-dose intravenous crenezumab arm, and having the most effect in patients with more mild MMSE scores. There was no significant cognitive change in patients who received low-dose subcutaneous crenezumab. Importantly, the sample size of the study was not expected to have adequate power to detect a modest but clinically significant difference between active medication and placebo at the 5% significance level (as is commonly the case in Phase 2 studies in AD). The BLAZE study results suggest that Abeta is being eliminated from the brain as patients showed a statistically significant increase in CSF Abeta 1–42, which confirms target engagement by crenezumab.

 

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