Applying precision medicine to find a better solution

Alzheon’s ALZ-801 (valiltramiprosate) is currently the only oral anti-amyloid treatment in Phase 3 testing for Alzheimer’s disease. We believe that ALZ-801 has the potential to significantly slow or stop disease progression, and even prevent the onset of clinical symptoms.

Development of ALZ-801, a well-tolerated new treatment, is based on ten years of Alzheon research into the biology of Alzheimer’s. Safety profile in ALZ-801 studies remains favorable & consistent with prior data in over 3,000 AD patients, with no evidence of vasogenic brain edema.

Using our pioneering precision medicine approach, we are initially focusing our development on the highest risk patients with two copies of the APOE4 gene (APOE4/4 homozygotes), who are predicted to benefit most from the ALZ-801 treatment. Future trials will expand treatment to patients with only one copy of the APOE4 gene, and ultimately to prevention of onset of Alzheimer’s.

Wall Street analyst Robyn Karnauskas of Truist Securities discussing with Alzheon management team new data and therapeutic potential of ALZ-801/valiltramiprosate.

ALZ-801 acts upstream of anti-amyloid drugs in AD

Validated approach supported by experts

  • Received $51M in grants from National Institute on Aging to fund APOLLOE4 Phase 3 study
  • Prominent global Scientific Advisory Board
  • Alzheon published 9 peer reviewed scientific publications on key discoveries in Alzheimer’s
Phase 2 trial Biomarker Steering Committee: the top 3 experts
Kaj Blennow, MD, PhD
Developed p-tau181 biomarker for AD
(on Aduhelm’s FDA label); Professor of Clinical Neurochemistry, University of Gothenburg, Sweden
Eric Reiman, MD
Developed p-tau217 biomarker for AD; Executive Director of Banner Alzheimer’s Institute, Chief Executive Officer of Banner Research, Phoenix
Philip Scheltens, MD, PhD
Developed imaging & fluid AD biomarkers; Managing Partner of LSP Dementia Fund; Director of the Alzheimer Center, VU University, Amsterdam, Netherlands

ALZ-801 (valiltramiprosate) profile superior to plaque-clearing antibodies

Only oral anti-amyloid drug in Phase 3 development

Alzheon publications: Tolar (2021) Int J Mol Sci; Tolar (2020) Alzheimers Res Ther; Tolar (2019) Alzheimers Dement
1Aducanumab Biologics License Application: Medical Safety Review, June 2021; 2Van Dyck NEJM 2023 & Lecanemab Ph3 presentation ADPD 2023
3Eli Lilly: Donanemab Phase 3 Press Release, May 2023 & Phase 2 study Mintun NEJM 2021 

Gantenerumab – AAIC 2022; Roche GRADUATE Phase 3 Studies Press Release, November 2022
Aducanumab – AAIC 2021 & CTAD 2021
Lecanemab – CTAD 2021; Swanson (2020) Alz Res Therapy; Eisai CLARITY AD Phase 3 Study Press Release, September 2022
ALZ-801 – CTAD 2022

Plasma p-tau181 reduction predicts clinical efficacy

ALZ-801 (valiltramiprosate) development strategy

Reflects current best internal estimates, subject to change; NDA – New Drug Application; sNDA – Supplemental New Drug Application