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ACD856: Phase I progressing after SAD data

AlzeCure Pharma 27 August 2021 Flash note
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AlzeCure Pharma

Clinical trial update

Pharma & biotech

27 August 2021



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Net cash (SEKm) at end-Q221


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Free float




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Nasdaq First North Growth

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Business description

AlzeCure Pharma is a clinical-stage biotech company based in Sweden focused on developing small molecule drugs for the treatment of AD (symptomatic and disease modifying) and pain (neuropathic and osteoarthritic).


Dr Jonas Peciulis

+44 (0)20 3077 5728

Dr Sean Conroy

+44 (0)20 3077 5700

AlzeCure Pharma is a research client of Edison Investment Research Limited

AlzeCure has provided an update on the Phase I trial for ACD856, reporting that some promising data were observed during the initial single ascending dose (SAD) part of the study. Importantly, good tolerability was observed, with the drug’s pharmacokinetic profile tracking well from preclinical and Phase 0 (micro-dosing) data. Based on these, the SAD part of the study will be expanded to investigate some higher doses as the drug’s therapeutic window might be larger than initially expected. The subsequent multiple ascending dose (MAD) part remains on track to start in H221. We continue to forecast $4.6bn peak sales at 5% probability for ACD856’s potential use in Alzheimer’s disease (AD), which contributes SEK13.1/share (c 60%) to our valuation of SEK21.9/share We anticipate more details to be communicated at an R&D event on 1 September (09:00 CEST), which will cover ACD856 and the NeuroRestore platform in more detail.

ACD856: Phase I progressing after SAD data

Year end

Revenue (SEKm)


































Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles and exceptional items.

ACD856 is AlzeCure’s lead asset (Phase I) and part of the NeuroRestore platform, which has the potential to become a first-in-class cognitive enhancer for AD. ACD856 improves the signalling of neurotrophins, including nerve growth factor and brain-derived neurotrophic factor, through positive modulation of the TrkA and TrkB, receptors and is expected to improve cognitive function and memory. This initial update on the safety and tolerability data from the SAD part of the study is promising in our view. Following the MAD part of the study, an extension phase is planned which will investigate the early cognitive effects of ACD856, with data expected sometime in 2022. Given the recent landmark FDA approval of Biogen’s drug Aduhelm in June, we believe there is resurgent interest from the industry in developing AD drugs and has likely provided a tailwind for AlzeCure’s business development activities.

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