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AC IMMUNE SA filed this Form 20-F on 03/21/2019
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AD diagnostics are a major market opportunity that will be driven by the growth in the aging population and the testing and availability of disease-modifying drugs. We believe a best-in-class Tau tracer has the potential to achieve a substantial market share in this large and growing market.


Alongside our AD diagnostics activities, we have a program targeting PET imaging agents for alpha-synuclein, an important protein involved in PD, and which progressively accumulates in structures in the PD brain. Scientists believe that the misfolding of alpha-synuclein is central to the neurodegenerative process of PD, as well as a number of other disorders, collectively called synucleinopathies, such as Lewy Body Dementia and Multiple System Atrophy, making it a priority target for development of therapeutics and diagnostics. We have identified molecules from our Morphomer library that stain selectively alpha-synuclein pathological structures in human PD brain sections with affinity in the low nanomolar range. Those molecules also have suitable properties for the development of PET ligands as evaluated in preclinical studies. Ongoing work to optimize the potency, selectivity and pharmacokinetics of these tracers is being funded by the Michael J. Fox Foundation for Parkinson’s Research and Biogen under the non-exclusive research and development agreement signed in April 2016. The collaboration with Biogen is expiring in April 2019. In September 2017 we were awarded a continuation of a February 2015 research grant from the Michael J. Fox Foundation for Parkinson's Research. Following the successful completion of this grant extension in 2018, we received an additional grant in November 2018 to conduct a first-in-human (FIH) study in H1 2019. The current status of the program has been presented on the following conferences in 2018/2019: AAT-AD/PD Focus Meeting in Torino, the AAIC 2018 conference in Chicago and the Human-Amyloid Imaging conference in Miami.


Figure 31: Overview of our alpha-synuclein PET program and current clinical candidate profile



Ref: AC Immune unpublished data


Currently there are no imaging products in the market that target alpha-synuclein. This provides us with a unique opportunity to become the market leader in alpha-synuclein PET imaging. We believe the ability to image alpha-synuclein deposits in the brain will enable:


·The diagnosis of PD at much earlier premotor stages than is now possible, thereby enabling early therapeutic intervention and corresponding better patient outcomes;


·The use of alpha-synuclein as a surrogate marker in clinical studies of novel therapeutic regimens designed to slow or halt progression of PD; and


·The diagnosis of sub-populations of PD and other synucleinopathies.



© AC Immune 2015