AC Immune Reports Top Line Results from TAURIEL Phase 2 Trial Evaluating Semorinemab in Early Alzheimer’s Disease
Multiple other clinical stage programs progressing as planned
Investigational new drug (IND) enabling studies ongoing for first-in-class therapeutic candidates targeting TDP-43 and alpha-synuclein
Discovery on novel neuroinflammation target NLRP3-ASC inflammasome, including antibody and small molecule MorphomerTM inhibitors, advancing
Additional data analyses are ongoing and
“One of AC Immune’s key strengths is our diversified approach and our broad pipeline of assets, fueled by our remarkably efficient SupraAntigen™ and Morphomer™ platforms and staff. This is evidenced by our novel therapeutic candidates targeting TDP-43 and alpha-synuclein, which have advanced rapidly from discovery into IND-enabling studies. Furthermore, we are particularly pleased with progress in our recently disclosed discovery program targeting the NLRP3-ASC inflammasome,”
Both TDP-43 and alpha-synuclein are major pathologies in NDD and are increasingly thought to be important co-pathologies in AD. AC Immune’s programs directed towards these targets are the most advanced and comprehensive in the field. AC Immune’s alpha-synuclein positron emission tomography (PET) tracer program for Parkinson’s disease (PD) diagnostics was recently recognized by the
Broad Pipeline and Upcoming Milestones in 2020
AC Immune’s additional anti-Tau clinical assets are outlined below as well as additional milestone tables from the broader pipeline.
- ACI-35.030 (anti-Tau vaccine): ACI-35.030 is the first anti-phospho-Tau (pTau) vaccine to reach Phase 2 clinical development. The vaccine generates a polyclonal antibody response that targets epitopes that differ from the epitope targeted by the monoclonal semorinemab. Importantly, these epitopes include an epitope specific to pTau, which is the pathological form of Tau protein responsible for the formation of tangles in AD. Additionally, the antibodies generated by this active immunization approach have pharmacokinetic properties that differ from those of injected semorinemab.
- ACI-3024 (anti-Tau inhibitor): ACI-3024 is a first-in-class small molecule that passes through cell membranes to allow for the inhibition of intracellular Tau aggregates, which is not easily achieved with a large antibody like semorinemab. Phase 1 results in healthy volunteers and data disclosure are expected by Eli Lilly and Company in 2020.
- Tau- PET tracer: AC Immune’s Tau-PET tracer has the potential to work as a critical tool in the further development of anti-Tau approaches by facilitating the design of clinical trials that hit on two key aspects of AC Immune’s Roadmap to Successful Therapies for Neurodegenerative Diseases – treating earlier and targeting more homogeneous populations. PI-2620 is currently being evaluated in a longitudinal Phase 2 study in patients with AD and a Phase 1 study (test/retest) in patients with progressive supranuclear palsy (PSP).
Details of the TAURIEL study
The Phase 2 TAURIEL study of semorinemab is a 73-week, double-blind, placebo-controlled trial to determine if it can slow the rate of clinical decline in early (prodromal to mild) AD. The study followed 457 participants across 97 study centers. The study did not meet the primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo, but did meet the primary safety endpoint. Overall, the incidence of adverse events was similar between semorinemab and placebo arms and further analysis of these safety data are currently underway. Two secondary endpoints, Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer’s
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Source: AC Immune SA