Priavoid GmbH, a Dusseldorf-based biotech, presented blinded interim safety data from its ongoing Phase II trial of PRI-002 in Alzheimer's disease at the AD/PD 2026 conference in Copenhagen, according to a company announcement. The data, drawn from the first 90 participants over 24 weeks in the PRImus-AD trial, reported low rates of amyloid-related imaging abnormalities across the blinded study population, and an independent Drug Safety and Monitoring Board recommended the trial continue without further ARIA monitoring after reviewing unblinded data.
In the blinded population, which included both PRI-002 and placebo arms without distinguishing between them, ARIA-E (edema) was observed at a rate of 2.2% and ARIA-H (hemorrhage) at 6.7%. The company noted these rates are consistent with placebo-arm ARIA rates from Phase III trials of donanemab (placebo ARIA-E: 1.9%; placebo ARIA-H: 7.4%) and lecanemab (placebo ARIA-E: 1.7%; placebo ARIA-H: 9.0%). Because the data remain blinded, no treatment effect can be attributed to PRI-002, and no apparent imbalance between arms was identified by the DSMB, which led to its recommendation to continue the study. The company did not disclose dosing details, and no efficacy data were reported.
PRImus-AD is a randomized, double-blind, placebo-controlled Phase II study enrolling 304 patients aged 55 to 80 with mild cognitive impairment or mild dementia due to Alzheimer's disease, conducted across 38 sites in six European countries. The trial is funded by PRInnovation GmbH, an affiliate of Germany's Federal Agency for Breakthrough Innovation (SPRIND). The interim analysis covers fewer than one-third of enrolled participants, and the data remain blinded and limited to safety observations. Efficacy endpoints were not disclosed in this readout, and the company has not stated when unblinded or efficacy results are expected.
PRI-002 is an orally available all-d-peptide designed to bind and disassemble neurotoxic amyloid-beta oligomers. The ARIA rates reported in the blinded PRImus-AD population contrast with treatment-arm rates from Phase III trials of anti-amyloid antibodies: donanemab showed ARIA-E of 24.0% and ARIA-H of 19.7%, while lecanemab showed ARIA-E of 12.6% and ARIA-H of 17.3%. Cross-trial comparisons are limited by differences in study design, duration, and patient populations, and the blinded nature of the PRImus-AD data precludes direct comparison of treatment-arm rates.
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