Kuiken schreef op 30 augustus 2018 10:10:
OPERATIONAL REVIEW
Lead compound PQ912 – a first-in-class highly specific and potent Glutaminyl Cyclase (QC) inhibitor
Detailed design of Phase 2b core program outlined
Probiodrug presented the detailed study design of the Phase 2b core program for its QC inhibitor which incorporated the newest FDA and EMA draft guidance for early AD trials.
The Phase 2b core program will consist of two clinical trials in the EU and USA. The first Phase 2b study will investigate the safety and efficacy of the optimal dose range of PQ912 in early AD patients. This trial will build on the excellent and efficient infrastructure established by the Phase 2a SAPHIR study. It is based on the valuable results of the SAPHIR study and has been designed with the guidance of international KOLs in the AD field. Prof Philip Scheltens, M.D. Ph.D., Director of the Alzheimer Center VU University Medical Center Amsterdam, NL, will once again serve as Principal Investigator and Chairperson for the study in the EU. A second complementary study is currently in the planning phase and is intended to be carried out in the USA at the Alzheimer Disease Cooperative Study Group (ADCS) at the University of California, San Diego, USA, which will be chaired by Prof Howard Feldman, also a highly renowned Principal Investigator.