- Blinded safety data from the ongoing Phase 2 trial suggest no treatment-related amyloid-related imaging abnormalities (ARIA) with PRI-002
- Drug Safety and Monitoring Board recommended continued advancement of PRI-002 in Phase 2 clinical development without further ARIA monitoring after review of unblinded data
Dusseldorf, Germany, March 17, 2026 - Priavoid GmbH (“Priavoid”) today announced promising initial safety data from its ongoing Phase 2 trial (PRImus-AD, NCT06182085) evaluating its lead candidate, PRI-002, for the treatment of Alzheimer’s disease (AD). The data were unveiled in an oral presentation by Prof. Dr. Dieter Willbold, CSO of Priavoid, at the AD/PD™ 2026 International Conference in Copenhagen, Denmark.
Based on blinded safety assessments from the first 90 participants over 24 weeks of treatment, the observed ARIA event rates were low and consistent with rates typically reported in placebo groups in Phase 3 studies of amyloid-beta-targeting antibodies. Taken together, these findings suggest an encouraging safety and tolerability profile for PRI-002 in the ongoing Phase 2 setting.
PRI-002 is a novel, orally available all-d-peptide candidate based on Priavoid’s proprietary detangler platform. The compound is designed to target amyloid-beta (Aβ) oligomers, a key driver associated with AD. In contrast to currently available treatments, PRI-002 is designed to bind neurotoxic Aβ oligomers and promote their disassembly into harmless monomers. Through its distinct mode of action, PRI-002 is designed to intervene early in the AD pathway by addressing neurotoxicity at its source while avoiding treatment-mediated immune responses that can trigger serious side effects including ARIA.
“These initial PRImus-AD data highlight the potential of PRI-002 as a safer, more targeted therapeutic approach for people living with AD. The absence of treatment-related ARIA events reinforces our confidence in our lead candidate as a truly innovative, disease-modifying approach capable of acting with fewer adverse events,” said Prof. Dr. Dieter Willbold, Chief Science Officer at Priavoid GmbH. “Our team is focused on advancing PRI-002 toward the next stages of clinical development to address the urgent unmet need in this notoriously challenging and devastating disease.”
The blinded interim analysis included safety observations from both the PRI-002 treatment and the placebo arms. In the blinded PRImus-AD population, ARIA-E (edema) was observed at a rate of 2.2% and ARIA-H (hemorrhage) at 6.7%. These rates are broadly consistent with placebo-arm ARIA rates reported in Phase 3 studies of donanemab and lecanemab (placebo ARIA-E: 1.9% and 1.7%; placebo ARIA-H: 7.4% and 9.0%, respectively), while notably lower than the treatment arms of those antibody trials (donanemab ARIA-E: 24.0%, ARIA-H: 19.7%; lecanemab ARIA-E: 12.6%, ARIA-H: 17.3%).1,2 These findings support the conclusion that PRI-002 has not demonstrated a treatment-related ARIA signal to date in PRImus-AD.
Following an unblinded review of relevant safety data, the independent Drug Safety and Monitoring Board (DSMB) recommended continuation of PRImus-AD without further ARIA monitoring, reinforcing Priavoid’s confidence in the ongoing clinical development of PRI-002.
About the PRImus-AD Phase 2 trial
PRImus-AD (NCT06182085) is a randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety and efficacy of PRI-002 in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD). The study enrolled 304 participants, aged 55-80 years, across 38 study locations in six European countries. PRI-002 is a first-in-class orally available all-d-peptide candidate designed to disassemble neurotoxic amyloid-beta (Aβ) oligomers and is being investigated as a potential disease-modifying treatment for cognitive impairment due to AD.
The PRImus-AD trial is funded by PRInnovation GmbH, affiliate of The Federal Agency for Breakthrough Innovation – SPRIND GmbH.
About Priavoid
Priavoid’s novel class of orally available all-d-peptide therapeutics detangle neurotoxic oligomer species to inhibit and reverse disease-specific protein aggregation in neurodegenerative disorders. We aim to establish clinical proof-of-concept through our lead program, PRI-002, which will complete a Phase 2 trial in Alzheimer’s disease in 2026. Priavoid has built a focused pipeline of detangler compounds that are non-immunogenic and reach their oligomer targets in the brain and inside the affected cells. Our goal is to develop disease-modifying therapies that address the underlying biology of neurodegeneration and drive meaningful clinical benefit for patients.
Contacts:
Priavoid GmbH
Email: media@priavoid.com
Media Requests
Trophic Communications
Anja Heuer and Marie Weickert, PhD
Phone: +49 151 106 199 05
Email: priavoid@trophic.eu
1 Van Dyck CH, et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9–21.
2 Sims JR, et al. Donanemab in Early Symptomatic Alzheimer’s Disease. JAMA. 2023;330(6):512–527.
