Probiodrug: Data Paint Positive Picture
Edison | Jun 16, 2017 04:52AM ET
Probiodrug AG. (AS:PDB) presented the first data from its flagship Phase IIa clinical trial with its lead drug candidate PQ912, a glutaminyl cyclase (QC) inhibitor, for early Alzheimer’s disease (AD) patients. Overall, we find the data positive, with several secondary endpoints and exploratory clinical tests especially piquing our interest. Our valuation is increased to €487m or €60/share.
Innovative trial design
The double-blind Phase IIa SAPHIR study examined PQ912 against placebo in 120 treatment-naive, early AD patients. The highest dose of 800mg tested in the Phase I study was selected and administered for three months, a relatively short period of time. Primarily this was a safety/tolerability trial, but secondary endpoints included exploratory efficacy tests, such as changes in AD-related biomarkers in the cerebrospinal fluid (CSF), change in brain function measured by MRI and electroencephalography (EEG) and cognitive tests. While this was a short study, in our view, it was well-designed to extract as much data as possible to appropriately design further efficacy studies.
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