contraloid (PRI-002) / Priavoid - LARVOL DELTA

Topline results from the Phase 2b PRImus-AD trial: Safety and efficacy of oral PRI-002 in early AD (CTAD 2026) - No abstract available

Clinical • P2b data

Pharmacokinetic properties of the clinical drug candidate PRI-002 with regard to genotype, sex, age, dose-dependence and food effects in mice. (PubMed, Eur J Pharm Sci) - "While at lower doses (200 mg/kg) the effect was substantial, plasma levels were 15 times higher in fasted than in non-fasted animals, the effect was only minor at higher RD2 doses (600 mg/kg). The results of this study indicate the important influence of prior food intake on the bioavailability of the compound, which may also apply to patients and is therefore of interest in further clinical development."

Journal • PK/PD data • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

PRImus-AD: Design, Recruitment and Baseline Data of the Phase 2 Study Treating Early AD Patients with the Novel Drug Candidate PRI-002 (CTAD 2026) - No abstract available

Clinical • P2 data

The unique mode of action of the orally applied PRI-002 and its confirmed target engagement in the phase 2b study PRImus-AD (CTAD 2026) - No abstract available

P2b data

PRImus-AD: Safety data of the Phase 2b study treating early AD patients with the novel drug candidate PRI-002 (CTAD 2026) - No abstract available

Clinical • P2b data

PRImus-AD: Biomarker Profile Data of the phase 2b study treating early AD patients with the novel drug candidate PRI-002 (CTAD 2026) - No abstract available

Biomarker • Clinical • P2b data

PRImus-AD: Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD) (clinicaltrials.gov) - P2 | N=304 | Completed | Sponsor: PRInnovation GmbH | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

A-beta Oligomer Lowering Treatment With PRI-002 Does Not Cause Aria In Ongoing Phase 2 Trial (AAIC 2026) - No abstract available

P2 data

The Amyloid β Targeting Compound Pri-002 Reduces Amyloid β Oligomers And Prevents Cognitive Decline In Various AD Animal Models (AAIC 2026) - No abstract available

Preclinical

A Placebo-controlled, Double-blind, Phase 1b Study To Evaluate Safety And Pharmacodynamics Of Orally Applied Pri-002 In Early Ad (AAIC 2026) - No abstract available

Clinical • P1 data • PK/PD data

PRIMUS-AD: DESIGN OF THE PHASE 2 STUDY TREATING EARLY AD PATIENTS WITH THE NOVEL DRUG CANDIDATE PRI-002 (ADPD 2026) - "The PRIMUS-AD phase 2 study enrolled 304 patients with MCI and mild dementia due to AD to assess safety and therapeutic benefit of PRI-002. Results are expected in Q3 2026."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • APOE

THE ABETA TARGETING COMPOUND PRI-002 REDUCES AΒETA OLIGOMERS AND PREVENTS COGNITIVE DECLINE IN VARIOUS AD ANIMAL MODELS (ADPD 2026) - "After decades of setbacks, the Anti-Aβ-Antibody Lecanemab received approval from the FDA and EMA for the treatment of AD, entering a new era of disease- modifying therapies. Preclinical results of PRI-002 reveal its potential as promising candidate for a disease-modifying treatment of AD. PRI-002 enters the brain and specifically disassembles toxic Aβ oligomers, resulting in improved cognitive and motor deficits, supporting its mode of action. The preclinical profile as well as the successfully conducted Phase I studies supports further clinical development of PRI-002."

Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

THE ABETA OLIGOMER DISASSEMBLING COMPOUND PRI-002 DOES NOT CAUSE ARIA IN AN ONGOING PHASE 2 TRIAL (ADPD 2026) - P2 | "In an ongoing phase 2 trial with oral PRI-002 that was designed to disassemble synaptotoxic Aβ aggregates into harmless Aβ monomers, the study drug is well tolerated and the safety profile favorable. Efficacy data are expected in 2026."

P2 data • Alzheimer's Disease • CNS Disorders • Dementia

Priavoid Presents Initial Phase 2 Data Suggesting Favorable Safety Profile for Alzheimer’s Candidate PRI-002 at AD/PD 2026 (GlobeNewswire) - "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%)."

P2 data • Alzheimer's Disease

Priavoid…announced it will present promising initial safety data from the ongoing Phase 2 trial (PRImus-AD, NCT06182085) evaluating its lead candidate PRI-002 in Alzheimer’s disease (AD)…at the upcoming AD/PD 2026 International Conference (GlobeNewswire) - "The results indicate a favorable safety and tolerability profile, particularly regarding Amyloid-Related Imaging Abnormalities (ARIA). Following review of relevant safety data, the Drug Safety and Monitoring Board (DSMB) recommended continuing the trial without further ARIA monitoring."

DSMB • P2 data • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - P2 | "The PRIMUS-AD phase 2 study will finally enroll about 300 patients with MCI and mild dementia due to AD to assess safety and therapeutic benefit of PRI-002. Results are expected mid-2026."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • APOE

Drug Development. (PubMed, Alzheimers Dement) - "PRI-002 was well tolerated. No biomarker changes have been found after 28 days of treatment. No ARIA were detected. Memory improved significantly in the verum group. The randomized, double-blind, placebo-controlled PRImus-AD phase 2 study has finished recruiting to assess safety and efficacy of PRI-002 in patients with MCI and mild dementia due to AD (EU CT# 2022-503148-41)."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • CSF P-tau

Developing Topics. (PubMed, Alzheimers Dement) - P2 | "In an ongoing phase 2 trial with oral PRI-002 that was designed to disassemble synaptotoxic Aβ aggregates into harmless Aβ monomers, the study drug is safe and in detail does not cause ARIA incidents Efficacy data are expected in 2026. Kutzsche J et al. Oral PRI-002 treatment in patients with MCI or mild AD. Nat. Commun. accepted, (2025)."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia

Anti-Abeta treatment without ARIA-E using the oligomer disassembling compound PRI-002 in an ongoing Phase 2 trial (CTAD 2025) - No abstract available

P2 data

The PRImus-AD study: design of the phase 2 study treating patients with MCI or mild dementia due to Alzheimer's disease (AD) with the orally available PRI-002 (CTAD 2025) - No abstract available

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Dementia

Oral PRI-002 treatment in patients with MCI or mild AD: a randomized, double-blind phase 1b trial. (PubMed, Nat Commun) - P1b | "Patients receiving PRI-002 performed significantly better than those receiving placebo in the CERAD word list at Day 56 (P ≤ 0.05). In conclusion, 28 days of treatment with 300 mg q.d. PRI-002 was well tolerated in patients with MCI or mild dementia due to AD."

Clinical • Journal • P1 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Hematological Disorders • CSF P-tau

PRImus-AD: Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD) (clinicaltrials.gov) - P2 | N=270 | Active, not recruiting | Sponsor: PRInnovation GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Developing Topics. (PubMed, Alzheimers Dement) - "PRI-002 was well tolerated. No biomarker changes have been found after 28 days of treatment. No ARIA were detected. Memory improved significantly in the verum group. A phase 2 study has started to assess the potential therapeutic benefit of PRI-002 in patients with mild neurocognitive impairment and mild dementia due to AD."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Hematological Disorders • CSF P-tau

Orally available PRI-002 for the treatment of Alzheimer´s disease: Phase 1a data and design of the phase 2a study (CTAD 2024) - No abstract available

P1 data • P2a data • Alzheimer's Disease • CNS Disorders

Design of a phase 2 study and results of a phase 1b study in MCI and mild AD patients with the orally available PRI-002 for the treatment of Alzheimer’s disease (AAIC 2024) - "PRI-002 was well tolerated. No biomarker changes have been found after 28 days of treatment. No ARIA were detected."

Clinical • P1 data • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Hematological Disorders • CSF P-tau