2:47 PM
 | 
Jul 21, 2017
 |  BioCentury  |  Product Development

Surrogate start

What Probiodrug’s Phase IIa results suggest about new biomarkers in AD

Phase II results for Probiodrug AG’s Alzheimer’s disease candidate point to potential surrogate markers for improvements in cognition that one day could be used in early development to handicap the likelihood of success in Phase III.

A major challenge in AD drug development has been the lack of biomarkers that can be easily assessed in early trials and that correlate with clinically meaningful outcomes like improvements in cognition and/or memory.

For example, companies with programs that target the beta amyloid pathway have relied on changes in amyloid plaque levels in the brain in Phase II to support moving into large, lengthy and expensive Phase III trials.

This obviously has not panned out.

Probiodrug’s SAPHIR data for PQ912, announced June 12, showed significant changes in theta power measured by EEG that correlated with significant improvements in cognition. The EEG marker and cognition tests were measured as secondary endpoints.

EEG measures synaptic connectivity. In patients with AD, the theta wave, which is a low frequency band that corresponds with slowing of brain activity, increases as disease progresses. This increase has been linked to cognitive decline in natural history studies in AD.

“Companies like Probiodrug will have to confirm it first before more companies start to use them.”

Philip Scheltens, VU University Medical Center

PQ912 is a glutaminyl cyclase (QC) inhibitor. The Phase IIa study tested a single dose of the candidate in 120 patients with...

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