contraloid (PRI-002) / Priavoid - LARVOL DELTA

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

MODE OF ACTION, PHASE IB DATA IN PATIENTS, AND PHASE II DESIGN OF THE ORALLY AVAILABLE ANTI-PRIONIC COMPOUND PRI-002 FOR THE TREATMENT OF ALZHEIMER'S DISEASE (ADPD 2024) - "PRI-002 showed an excellent safety profile in MCI and mild AD patients. A significant improvement of short-term memory function was noted at follow up. Despite the small number of patients, we feel that this phase Ib study results deserve reporting to the scientific community."

Clinical • P1 data • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

An orally available N-type calcium channel inhibitor for the treatment of neuropathic pain. (PubMed, Br J Pharmacol) - "Taken together, these results demonstrate that RD2 has antiallodynic properties. RD2 is orally available, which is the most convenient application form for patients and caregivers. The surprising and novel result from standard receptor screens opens the room for further optimization into new promising drug candidates, which address an unmet medical need."

Journal • Neuralgia • Pain

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 | Recruiting | Sponsor: PRInnovation GmbH

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

In vitro, ex vivo and clinical data from patients demonstrate that the purely thermodynamic anti-prionic mode of action for the treatment of neurodegenerative diseases is promising (Neuroscience 2023) - "Patients received once daily oral doses of 300 mg PRI-002 or placebo for 28 days... The all-D-enantiomeric ligand for α-synuclein, SVD-1a, disassembled preformed α-synuclein fibrils (PFF) as shown by AFM, DLS and SEC analysis. SPR and NMR demonstrated picomolar affinity of SVD-1a to α-synuclein monomers, while keeping them in their physiological IDP conformation. The all-D-enantiomeric ligand for Aβ, RD2, demonstrated ex vivo target engagement and disassembled Aβ oligomers obtained from brain tissue of former AD patients."

Clinical data • Preclinical • Alzheimer's Disease • CNS Disorders • Parkinson's Disease • Proteinopathy

The purely thermodynamic anti-prionic mode of action for the treatment of neurodegenerative diseases (CTAD 2023) - "Patients received once daily oral doses of 300 mg PRI-002 or placebo for 28 days... The unique anti-prionic mode of action for the treatment of AD, PD and other protein misfolding diseases is promising."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease • Proteinopathy

Mode of action, clinical phase Ib data in patients, and the phase II design of the orally available anti-prionic compound PRI-002 that disassembles Aβ oligomers into Aβ monomers (CTAD 2023) - "PRI-002 showed an excellent safety profile in MCI and mild AD patients. While no significant biomarker changes were detected after 4 weeks of treatment, a significant improvement of shortterm memory function was noted at follow up. Despite the small number of patients, we feel that this phase Ib study results deserve reporting to the scientific community."

Clinical • P1 data • P2 data • CNS Disorders • Cognitive Disorders

Oral treatment with the all-d-peptide RD2 enhances cognition in aged beagle dogs - A model of sporadic Alzheimer's disease. (PubMed, Heliyon) - "RD2 has previously demonstrated pharmacodynamic efficacy in three different transgenic AD mouse models in three different laboratories. Here, we demonstrate that oral treatment with RD2 significantly reduced cognitive deficits in cognitively impaired aged Beagle dogs even beyond the treatment end, which suggests in combination with the treatment dependent CSF tau oligomer decrease a disease-modifying effect of RD2 treatment."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Evaluation of the F-Labeled Analog of the Therapeutic All-d-enantiomeric Peptide RD2 for Amyloid β Imaging. (PubMed, Eur J Pharm Sci) - "In vivo uptake and biodistribution of [F]RD2-cFPy were evaluated using PET analyses in wild-type and transgenic APP/PS1 mice. Although brain penetration and brain wash-out kinetics of the radioligand were low, this study provides proof of principle for a PET probe based on a d-enantiomeric peptide binding to soluble Aβ species."

Journal • Alzheimer's Disease • CNS Disorders

REALIZATION OF THE ANTI-PRIONIC MODE OF ACTION FOR PROTEIN-MISFOLDING DISEASES BY PURELY THERMODYNAMIC ACTING AND TARGET PROTEIN SPECIFIC ALL-D-PEPTIDES (ADPD 2023) - "I will also acknowledge the many contributors of both developments that are too many to be included here in the abstract. Conclusions The unique anti-prionic mode of action for the treatment of AD, PD and other protein misfolding diseases is promising."

Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease • Proteinopathy

A UNIQUE MODE OF ACTION FOR THE TREATMENT OF AD (ADPD 2023) - "We were able to prove in vitro , ex vivo and in vivo the new anti -prionic mode of action of RD2."

Alzheimer's Disease • CNS Disorders