Varoglutamstat – lead product candidate in AD

Tackling AD at the roots: early intervention to address multiple hallmarks of AD

Bildschirmfoto 2021-08-18 um 16.15.18

Clinical development of varoglutamstat

Phase 1 – Completed

Phase 2a SAPHIR – Completed

Phase 2b VIVIAD – EU Study, Ongoing

Phase 2a/b VIVA-MIND – US Study, Ongoing

Safety and tolerability in 205 healthy volunteers

Varoglutamstat is well-tolerated

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)

Safety, tolerability and efficacy in 250 Patients MCI and mild AD

Endpoints: safety, attention/ working memory, NTB, biomarkers

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.