HALLE (SAALE), Germany, 09 January 2017 - Probiodrug AG ("Probiodrug", Euronext: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), announces that recruitment for the Phase 2a SAPHIR study has been completed in mid-December 2016. A total of 120 patients have been randomised, surpassing the 110 patients planned in the study protocol.
The SAPHIR study is a randomized, double blind study comparing PQ912 to placebo in treatment naïve patients with early AD. PQ912 targets inhibition of the Glutaminyl Cyclase (QC) enzyme which reduces production of highly neurotoxic pGlu-Abeta and related oligomers implicated in AD. PQ912 has been extensively investigated in a Phase 1 SAD/MAD study showing good tolerability and a dose dependent QC-inhibition in the spinal fluid.
The primary objective of the SAPHIR study is to investigate the safety of PQ912 in the target population and the secondary objective is to assess the pharmacodynamics profile through various readouts.
In this study Mini-Mental State Examination (MMSE) and the Cogstate neuro-psychological tests are monitored blindly every 30 patients to ensure consistency and reliability of ratings. First blinded results at baseline show that the mean MMSE scores from the 120 randomised patients is 25.3, the mean age is 73 years and gender distribution is 64 female and 56 male. Current results indicate a low variability and therefore the high quality of the assessments being used.
Full unblinded results of the SAPHIR study are expected in the second quarter of 2017.
The SAPHIR study is a randomized, double blind study comparing PQ912 to placebo in treatment naïve patients with early AD. PQ912 targets inhibition of the Glutaminyl Cyclase (QC) enzyme which reduces production of highly neurotoxic pGlu-Abeta and related oligomers implicated in AD. PQ912 has been extensively investigated in a Phase 1 SAD/MAD study showing good tolerability and a dose dependent QC-inhibition in the spinal fluid.
The primary objective of the SAPHIR study is to investigate the safety of PQ912 in the target population and the secondary objective is to assess the pharmacodynamics profile through various readouts.
In this study Mini-Mental State Examination (MMSE) and the Cogstate neuro-psychological tests are monitored blindly every 30 patients to ensure consistency and reliability of ratings. First blinded results at baseline show that the mean MMSE scores from the 120 randomised patients is 25.3, the mean age is 73 years and gender distribution is 64 female and 56 male. Current results indicate a low variability and therefore the high quality of the assessments being used.
Full unblinded results of the SAPHIR study are expected in the second quarter of 2017.
