Varoglutamstat – lead product candidate in AD
Tackling AD at the roots: early intervention to address multiple hallmarks of AD
Clinical development of varoglutamstat
Phase 1 – Completed
Safety and tolerability in 205 healthy volunteers
Varoglutamstat is well-tolerated
Phase 2a SAPHIR – Completed
Safety and tolerability in 120 patients with early AD
3-month treatment significantly improved working memory (One Back Test) and synaptic function (EEG), as well as neuroinflammation (CSF Biomarkers)
Phase 2b VIVIAD – EU Study, Ongoing
Safety, tolerability and efficacy in 250 Patients MCI and mild AD
Endpoints: safety, attention/ working memory, NTB, biomarkers
Phase 2a/b VIVA-MIND – US Study, Ongoing
Efficacy and safety in 414 patients with early AD
Endpoints: safety, attention/ working memory, CDR-SB biomarkers
Initial Phase 2a in 180 patients with stage-gate to Phase 2b with additional 234 patients
Strategic regional partnership with Simcere
In June 2021, we entered into a strategic regional licensing partnership with Simcere Pharmaceutical Group to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat AD in Greater China.
The agreement grants Simcere a regional license to develop and commercialize varoglutamstat as well as our preclinical monoclonal N3pE-antibody PBD-C06 in the Greater China region. Read more here.