Priavoid reports encouraging safety data from the Phase 2 PRImus-AD trial of oral Alzheimer’s candidate PRI-002, showing low ARIA rates comparable to placebo arms in antibody studies
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
Priavoid GmbH has reported promising initial safety findings from its ongoing Phase 2 PRImus‑AD trial (NCT06182085) evaluating the investigational therapy PRI‑002 in patients with Alzheimer’s disease. The data were presented at the AD/PD™ 2026 International Conference in Copenhagen by the company’s Chief Scientific Officer, Prof. Dr. Dieter Willbold.
The interim analysis included blinded safety data from the first 90 participants treated for 24 weeks. According to the company, rates of amyloid‑related imaging abnormalities (ARIA) were low and comparable to placebo‑arm rates reported in Phase 3 studies of amyloid‑targeting antibodies, suggesting a favorable safety and tolerability profile for PRI‑002.
PRI‑002 is a novel, orally available all‑D‑peptide developed using Priavoid’s proprietary detangler platform. The candidate targets toxic amyloid‑beta (Aβ) oligomers, which are believed to drive neurodegeneration in Alzheimer’s disease. Unlike antibody therapies that rely on immune‑mediated plaque clearance, PRI‑002 binds neurotoxic Aβ oligomers and promotes their disassembly into harmless monomers, aiming to intervene early in the disease pathway while avoiding immune‑mediated side effects such as ARIA.
“These initial PRImus‑AD data highlight the potential of PRI‑002 as a safer, more targeted therapeutic approach for people living with Alzheimer’s disease. The absence of treatment‑related ARIA events reinforces our confidence in this innovative, disease‑modifying approach capable of acting with fewer adverse events,” said Prof. Dr. Dieter Willbold, Chief Scientific Officer at Priavoid.
In the blinded PRImus‑AD population, ARIA‑E (edema) occurred in 2.2% of participants and ARIA‑H (hemorrhage) in 6.7%. These rates were broadly consistent with placebo‑arm ARIA rates reported in Phase 3 trials of donanemab and lecanemab and lower than ARIA rates typically observed in the treatment arms of those antibody studies.
Following an unblinded review of safety data, the trial’s independent Drug Safety and Monitoring Board (DSMB) recommended continuation of the PRImus‑AD trial without additional ARIA‑specific monitoring.
The PRImus‑AD (NCT06182085) study is a randomized, double‑blind, placebo‑controlled Phase 2 trial evaluating the safety and efficacy of PRI‑002 in 304 patients aged 55–80 years with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease across 38 sites in six European countries. The trial is funded by PRInnovation GmbH, an affiliate of the Federal Agency for Breakthrough Innovation (SPRIND GmbH).
Reference
Priavoid Presents Initial Phase 2 Data Suggesting Favorable Safety Profile for Alzheimer’s Candidate PRI-002 at AD/PD™ 2026, 17 March 2027, Priavoid Presents Initial Phase 2 Data Suggesting Favorable Safety Profile for Alzheimer’s Candidate PRI-002 at AD/PD™ 2026 – Priavoid
Study to Assess Safety and Efficacy of PRI-002 in Patients with MCI to Mild Dementia Due to Alzheimer’s Disease (AD) (PRImus-AD), ClinicalTrials.gov ID NCT06182085, https://clinicaltrials.gov/study/NCT06182085
About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.