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

Safety and tolerability in 205 healthy volunteers

Varoglutamstat is well-tolerated

Phase 2a SAPHIR – Completed

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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

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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

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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.