Priavoid GmbH has announced promising initial safety data from its ongoing phase 2 trial (PRImus-AD) evaluating its lead candidate, PRI-002, for the treatment of Alzheimer’s disease (AD).
The data were unveiled in an oral presentation by 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,” Willbold said.
“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 (haemorrhage) at 6.7%. These rates are broadly consistent with placebo-arm ARIA rates reported in phase 3 studies of donanemab and lecanemab, while notably lower than the treatment arms of those antibody trials. The 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.