Randomised, Double-blind, Placebo-controlled Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD) (PRImus-AD)

Alzheimer's disease (AD) is the most common form of dementia. In the brains of people with AD, certain small substances stick together. This leads to changes in thinking and behaviour. The company PRInnovation is developing a new treatment for Alzheimer's disease, called PRI-002. It is thought that PRI-002 can cut the sticked substances back into small pieces. That would reduce the effects of Alzheimer's disease. In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment (MCI) or mild dementia due to AD.

Start Date15 Feb 2024

Sponsor / Collaborator

Prinnovation GmbH

[+2]

NCT04711486

/ CompletedPhase 1IIT

A Single-centre, Randomized, Placebo-controlled, Double-blind, Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential to influence the chronic neurodegenerative process of AD. As Contraloid was so far only administered to healthy subjects, the rational of the proposed study is first to collect safety data in patients diagnosed with MCI due to AD, as the absorption, distribution, metabolism and excretion processes may be altered by disease, aging, comorbidities and concomitant drug therapies. Additionally, the design of a subsequent phase II study will be based on the data of this study. The results of the exploratory analyses will enable power calculations and the identification of the most useful and reliable biomarkers for the subsequent proof of concept phase II study.

Start Date08 Dec 2020

Sponsor / Collaborator

Charité - Universitätsmedizin Berlin

[+1]

NCT03955380

/ CompletedPhase 1IIT

Single-center, Randomized, Prospective, Double-blind, Placebo Controlled Phase Ib Study With an Adaptive Multiple Ascending Dose (MAD) Design to Investigate the Safety, Tolerability, Pharmacokinetics of Contraloid Acetate (Healthy Subjects)

This is a single-center multiple-ascending-dose clinical trial assessing the safety and tolerability of oral dosing of Contraloid acetate in healthy volunteers. The study drug Contraloid (alias RD2, alias PRI-002) is an orally available all-D-peptide, which was developed to directly destroy toxic and replicating A-beta oligomer prions, by disassembling them into A-beta monomers. The study drug is specifically designed for the curative or at least disease-modifying treatment of cognition, memory and behavior deficits in Alzheimer´s disease patients. The study drug is BBB penetrable [1] and has demonstrated target engagement in vitro and in vivo [2, 3]. Treatments in three different transgenic mouse models in three different laboratories yielded improved cognition and deceleration of neurodegeneration, even under truly non-preventive treatment conditions and even when applied orally [2-5]. The hereby obtained PRI-002 plasma levels have also been achieved in humans after single oral dosing.

Start Date12 Dec 2018

Sponsor / Collaborator

Forschungszentrum Julich

[+5]

100 Clinical Results associated with PRI-002

100 Translational Medicine associated with PRI-002

100 Patents (Medical) associated with PRI-002

Literatures (Medical) associated with PRI-002

01 Dec 2025·Alzheimers & Dementia

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

Article

Author: Brener, Alexander ; Tischler, Gerhard ; Kauselmann, Gunther ; Lindner, Katja ; Peters, Oliver ; Adermann, Knut ; Jürgens, Dagmar ; Gabelich, Julie‐Anne ; Willbold, Dieter ; Bartsch, Tina ; Zeiger, Kathrin

Abstract:

Background:

The drug candidate PRI‐002 is an all‐D‐enantiomeric peptide and was developed to disassemble toxic Aβ oligomers into harmless Aβ monomers. It is anticipated that PRI‐002 reduces neurotoxicity and restores synaptic plasticity in early stages of AD. In studies in healthy volunteers and in patients with mild cognitive impairment (MCI) and mild dementia due to AD (EudraCT 2020‐003416‐27) the orally administered PRI‐002 has demonstrated to be safe and well tolerable.

Method:

The PRImus‐AD study (EU clinical trial number 2022‐503148‐41) is a randomized, double‐blind, placebo‐controlled study to assess safety and efficacy of PRI‐002 in patients with MCI or mild dementia due to Alzheimer’s Disease (AD). The trial is conducted in six European counties at 40 study sites. The trial is registered at euclinicaltrials.eu/search‐for‐clinical‐trials/?lang=en&EUCT=2022‐503148‐41‐00 and clinicaltrials.gov/study/NCT06182085. CSF or Amyloid‐PET is used to confirm AD pathology. Stratification factors are disease state (MCI or mild dementia) and APOE e4 status. Eligible patients were randomly assigned (1:1:1) to receive 300 or 600 mg PRI‐002 per day or placebo following an adaptive design for 48 to 96 weeks of treatment duration. A follow‐up assessment is planned 12 weeks after the end of treatment. Besides to the endpoint of primary safety objectives the efficacy will be assessed by the change from baseline to week 48 in global outcome as measured by CDR‐SB.

Result:

540 patients in total were screened. Screening was accomplished three months ahead of the original schedule. A Screening Failure Rate of 42 % resulted in approx. 300 eligible patients (at the date of abstract submission) randomly assigned to 300 or 600 mg PRI‐002 per day or placebo. A blinded sample size recalculation confirmed the initial calculation of subjects to be enrolled. Although PRI‐002 is not expected to induce ARIAs, ARIA monitoring is closely performed for the first 90 patients until week 24.

Conclusion:

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.

01 Jul 2025·ANTICANCER RESEARCH

Resveratrol Derivatives Inhibit Pro-survival Akt Signaling Pathway in Lung Cancer

Article

Author: NICHARAT SRIRATANASAK ; BHURICHAYA INNETS ; ZIN ZIN EI ; PITHI CHANVORACHOTE ; SATAPAT RACHA

BACKGROUND/AIM:

Akt signaling promotes cancer survival and therapy resistance. This study aimed to modify and improve resveratrol's efficacy by enhancing apoptosis induction in non-small cell lung cancer.

MATERIALS AND METHODS:

Molecular docking analysis was used to investigate the binding between resveratrol derivatives and the Akt protein. Western blot analysis evaluated the levels of apoptosis markers and signaling proteins.

RESULTS:

Resveratrol derivative, RD4 (4-(3-hydroxy-4-methoxyphenethyl)-2,6-dimethoxyphenol), shows binding potential to the allosteric site of Akt. After treatment of H460 cells with RD4 for 24 h, increased apoptosis and decreased levels of phosphorylated-Akt (p-Akt) protein were observed. Moreover, the levels of pro-apoptotic protein Bax and cleaved PARP were elevated, while those of the anti-apoptotic protein Bcl-2 were decreased. However, RD2 exhibited moderate effects at high concentrations and RD3 elevated p-Akt expression while exhibiting no apoptotic activity.

CONCLUSION:

RD4 suppresses Akt pathways by binding at the allosteric site of Akt. These findings provide a rationale for the design and optimization of novel Akt targeting agents for non-small cell lung cancer treatment.

01 Jun 2024·British Journal of Pharmacology

An orally available Ca_v2.2 calcium channel inhibitor for the treatment of neuropathic pain

Article

Author: Jörg Breitkreutz ; Olaf Kletke ; Esther Wollert ; Janine Kutzsche ; Dieter Willbold ; Patricia Hidalgo ; Antje Willuweit ; Dagmar Jürgens ; Nikolaj Klöcker ; Holger Stark ; Ian Gering ; Annette G. Beck-Sickinger ; Gustavo A. Guzman

Abstract:

Background and Purpose:

Neuropathic pain affects up to 10% of the global population and is caused by an injury or a disease affecting the somatosensory, peripheral, or central nervous system. NP is characterized by chronic, severe and opioid‐resistant properties. Therefore, its clinical management remains very challenging. The N‐type voltage‐gated calcium channel, Cav2.2, is a validated target for therapeutic intervention in chronic and neuropathic pain. The conotoxin ziconotide (Prialt®) is an FDA‐approved drug that blocks Cav2.2 channel but needs to be administered intrathecally. Thus, although being principally efficient, the required application route is very much in disfavour.

Experimental Approach and Key Results:

Here, we describe an orally available drug candidate, RD2, which competes with ziconotide binding to Cav2.2 at nanomolar concentrations and inhibits Cav2.2 almost completely reversible. Other voltage‐gated calcium channel subtypes, like Cav1.2 and Cav3.2, were affected by RD2 only at concentrations higher than 10 μM. Data from sciatic inflammatory neuritis rat model demonstrated the in vivo proof of concept, as low‐dose RD2 (5 mg·kg‐1) administered orally alleviated neuropathic pain compared with vehicle controls. High‐dose RD2 (50 mg·kg‐1) was necessary to reduce pain sensation in acute thermal response assessed by the tail flick test.

Conclusions and Implications:

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.

News (Medical) associated with PRI-002

19 Mar 2026

·www.biospace.com

Priavoid Presents Preclinical Proof-of-Concept for PRI-101 Demonstrating α-synuclein Aggregate Disassembly at AD/PD™ 2026

PRI-101 inhibited aggregation of α-synuclein and actively disassembled fibrils across in vitro and in vivo models relevant to Parkinson’s disease Dusseldorf, Germany, March 19, 2026 - Priavoid GmbH (“Priavoid”) today announced preclinical proof-of-concept data for PRI-101, its orally available all-d-peptide candidate being developed for the treatment of Parkinson’s disease (PD) and related synucleinopathies. The data will be presented in a poster session by Dr. Marc Sevenich at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD TM 2026) in Copenhagen, Denmark. PRI-101 was developed using Priavoid’s proprietary detangler platform and is designed to target and disassemble α-synuclein (α-syn) aggregates, which play a key role in the disease pathology and in the induction of toxicity that leads to neurodegeneration in PD, multiple system atrophy (MSA), and other synucleinopathies. PRI-101 is binding to the α-syn subunit within toxic and self-replicating neurodegenerative aggregates and promoting their conversion back towards native, non-toxic forms, with the aim of counteracting disease-driving aggregation processes. “Parkinson’s disease affects more than 6 million people worldwide and remains an area of profound unmet medical need, with patients still lacking therapies that meaningfully alter the course of disease,” said Dr. Antje Willuweit, Director Preclinical Development at Priavoid GmbH . “Taken together, these preclinical data suggest that PRI-101 has the potential to be a first-in-class therapeutic candidate with disease-modifying potential for Parkinson’s disease and other related synucleinopathies. We look forward to advancing this candidate towards the clinic to address a substantial need for new disease-modifying therapeutic options.” Preclinical data presented at the conference demonstrated that PRI-101 can directly target and reduce pathological α-syn aggregates across multiple Parkinson’s disease models. In vitro studies showed that PRI-101 disassembled α-syn preformed fibrils (PFFs) and deactivated their seeding activity in a concentration- and time-dependent manner. It also demonstrated ex vivo target engagement, reducing α-syn aggregate levels in postmortem brain samples from patients with PD, MSA, and dementia with Lewy bodies. Pharmacokinetic studies following single and multiple doses confirmed that PRI-101 efficiently crosses the blood brain barrier and achieves meaningful penetration into the brain. In a human brain organoid model system for synucleinopathies and two distinct PD mouse models, PRI-101 reduced α-syn aggregates and levels of phosphorylated α-syn, a marker of α-syn aggregation. In vivo , PRI-101 was associated with prolonged median survival versus placebo. Short- and long-term treatment also led to a dose-dependent reduction of α-syn aggregates in the brain (including in the substantia nigra), accompanied by significant improvements in behavioral performance. This work is funded by a grant from The Michael J. Fox Foundation for Parkinson’s Research. About Priavoid Priavoid’s novel class of orally available all-d-peptide therapeutics detangle neurotoxic oligomer species to inhibit and reverse disease-specific protein aggregation in neurodegenerative disorders. We aim to establish clinical proof-of-concept through our lead program, PRI-002, which will complete a Phase 2 trial in Alzheimer’s disease in 2026. Priavoid has built a focused pipeline of detangler compounds that are non-immunogenic and reach their oligomer targets in the brain and inside the affected cells. Our goal is to develop disease-modifying therapies that address the underlying biology of neurodegeneration and drive meaningful clinical benefit for patients. Contacts: Priavoid GmbH Email: media@priavoid.com Media Requests Trophic Communications Anja Heuer and Marie Weickert, PhD Phone: +49 151 106 199 05 Email: priavoid@trophic.eu

Phase 2

17 Mar 2026

·firstwordpharma.com

Priavoid's oral Alzheimer's drug steers clear of ARIA in Phase II study

Brain swelling and microbleeds have been a thorn in the side of Alzheimer's drug developers. The complications are associated with amyloid plaque-busting antibodies such as Eisai and Biogen's Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab) to one degree or another, but one Düsseldorf-based biotech is reporting early data for an oral candidate that appears to be avoiding those safety pitfalls. Priavoid's all-D-peptide, called PRI-002, takes aim at one of the earlier and most destructive players in Alzheimer's disease pathology: amyloid-beta (Aβ) oligomers, toxic protein clusters that gum up communication between neurons and eventually clump together into larger Aβ plaques that drugs like Leqembi and Kisunla aim to clear. Taming toxic oligomers However, the neuroinflammatory cascade unleashed by that clean-up, including the tearing down of Aβ plaques from blood vessel walls, can trigger immune-mediated side effects better known as amyloid-related imaging abnormalities (ARIA). Priavoid said PRI-002's mechanism breaks up the oligomers into smaller, harmless fragments before the damage compounds and shows up as cognitive decline, and it's designed to do that without eliciting inflammatory responses that could lead to ARIA and its manifestations of oedema (ARIA-E) and haemorrhaging (ARIA-H). "If you are able with the compound to target the oligomers, you might catch them and break them up into the natural occurring monomers even before they can exhibit the synaptic dysfunction," Gerhard Tischler, the project lead for Priavoid's Phase II PRImus-AD study, told FirstWord. Placebo-like ARIA rates Interim data from the ongoing study were presented Tuesday at the Alzheimer's & Parkinson's Diseases (AD/PD) conference, with an emphasis on safety. According to the company, blinded assessments from the first 90 participants over 24 weeks showed ARIA-E and ARIA-H occurred at rates of 2.2% and 6.7% — rates that look "broadly consistent" to the placebo arms in the Phase III Clarity AD and TRAILBLAZER-ALZ 2 studies used to back the approvals of Leqembi and Kisunla, respectively. By the same token, the PRI-002 rates are also quite a bit lower than the treatment arms of those two antibody trials; the incidence of ARIA-E was 12.6% with Leqembi and 24% with Kisunla, while ARIA-H was 17.3% and 19.7%, respectively. Since Kisunla's approval in 2024, Lilly has introduced a more gradual titration schedule that cuts ARIA-E by 41% at 24 weeks with a 35% reduction at one year versus the original schedule (see – Physician Views Results: Kisunla widens its lead over Leqembi with new, safer dosing). Based on the interim PRImus-AD findings, an independent Drug Safety and Monitoring Board has recommended the trial continue without additional ARIA monitoring. The Phase II study has enrolled 304 patients ages 55-80 with mild cognitive impairment or mild dementia due to Alzheimer's across six European countries and is expected to wrap in April, according to ClinicalTrials.gov. "Everything comes down to efficacy, right?" said CEO Philipp Bürling. "If it's a good combination of efficacy and/or safety — that is, in whatever aspect superior to one of the approved antibodies or one of the antibodies in the pipelines — we just need to be better." As for where a drug like PRI-002 could eventually fit in the treatment algorithm for Alzheimer's, Bürling is taking a wait-and-see approach. "No one really knows what the landscape of approved [Alzheimer's] drugs is going to look like in the beginning of the 2030s," he said. "But, of course, we have expectations" that include use as monotherapy or as potential combination approaches, "so there's very different schemes where PRI-002 could fit in, but I think we should not speculate too much, but focus on…how it works for now."

Phase 2Clinical ResultPhase 3

17 Mar 2026

·www.biospace.com

Priavoid Presents Initial Phase 2 Data Suggesting Favorable Safety Profile for Alzheimer’s Candidate PRI-002 at AD/PD™ 2026

Blinded safety data from the ongoing Phase 2 trial suggest no treatment-related amyloid-related imaging abnormalities (ARIA) with PRI-002 Drug Safety and Monitoring Board recommended continued advancement of PRI-002 in Phase 2 clinical development without further ARIA monitoring after review of unblinded data Dusseldorf, Germany, March 17, 2026 - Priavoid GmbH (“Priavoid”) today announced promising initial safety data from its ongoing Phase 2 trial (PRImus-AD, NCT06182085 ) evaluating its lead candidate, PRI-002, for the treatment of Alzheimer’s disease (AD). The data were unveiled in an oral presentation by Prof. Dr. 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 pro 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,” said Prof. Dr. Dieter Willbold, Chief Science Officer at Priavoid GmbH . “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 (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%). 1 ,2 These 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. About the PRImus-AD Phase 2 trial PRImus-AD ( NCT06182085 ) is a randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety and efficacy of PRI-002 in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD). The study enrolled 304 participants, aged 55-80 years, across 38 study locations in six European countries. PRI-002 is a first-in-class orally available all-d-peptide candidate designed to disassemble neurotoxic amyloid-beta (Aβ) oligomers and is being investigated as a potential disease-modifying treatment for cognitive impairment due to AD. The PRImus-AD trial is funded by PRInnovation GmbH, affiliate of The Federal Agency for Breakthrough Innovation – SPRIND GmbH . About Priavoid Priavoid’s novel class of orally available all-d-peptide therapeutics detangle neurotoxic oligomer species to inhibit and reverse disease-specific protein aggregation in neurodegenerative disorders. We aim to establish clinical proof-of-concept through our lead program, PRI-002, which will complete a Phase 2 trial in Alzheimer’s disease in 2026. Priavoid has built a focused pipeline of detangler compounds that are non-immunogenic and reach their oligomer targets in the brain and inside the affected cells. Our goal is to develop disease-modifying therapies that address the underlying biology of neurodegeneration and drive meaningful clinical benefit for patients. Contacts: Priavoid GmbH Email: media@priavoid.com Media Requests Trophic Communications Anja Heuer and Marie Weickert, PhD Phone: +49 151 106 199 05 Email: priavoid@trophic.eu 1 Van Dyck CH, et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9–21. 2 Sims JR, et al. Donanemab in Early Symptomatic Alzheimer’s Disease. JAMA . 2023;330(6):512–527.

Phase 2Clinical Result

100 Deals associated with PRI-002

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 2	Czechia	Priavoid GmbH	15 Feb 2024
Alzheimer Disease	Phase 2	Germany	Priavoid GmbH	15 Feb 2024
Alzheimer Disease	Phase 2	Italy	Priavoid GmbH	15 Feb 2024
Alzheimer Disease	Phase 2	Netherlands	Priavoid GmbH	15 Feb 2024
Alzheimer Disease	Phase 2	Poland	Priavoid GmbH	15 Feb 2024
Alzheimer Disease	Phase 2	Spain	Priavoid GmbH	15 Feb 2024
Mild cognitive disorder	Phase 2	Czechia	Priavoid GmbH	15 Feb 2024
Mild cognitive disorder	Phase 2	Germany	Priavoid GmbH	15 Feb 2024
Mild cognitive disorder	Phase 2	Italy	Priavoid GmbH	15 Feb 2024
Mild cognitive disorder	Phase 2	Netherlands	Priavoid GmbH	15 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06182085 (PRImus‑AD, Pubmed \| Alzheimers Dement)	Phase 2	-	300	PRI-002 300 mg	qkbbkbnfgr(yvbxiamzni) = iauvwpdosc ctprzywllx (twgpcbgwer )	Positive	01 Dec 2025
				PRI-002 600 mg	faddkolqvu(pvcjnfdcsh) = possezxmfq tkrfjerknu (zesnimyowy ) View more
CTAD2022	Phase 1	Aβ1-42 \| Aβ oligomers	20	RD2	qljhniodac(uljonkhkqs) = 13 patients reported in total 27 adverse events while no serious adverse event was noted. There was no statistical difference regarding adverse events between treatment and placebo. In contrast to reported anti- Aβ-antibody-treatments, no ARIA events have been observed. ufukummuin (ypxwispzes ) View more	Positive	03 Dec 2022
				Placebo
NCT04711486 (AAIC 12022 \| AAIC 22022) Manual	Phase 1	Alzheimer Disease	19	PRI-002 300 mg	wzmztpisfd(fjmpnnvmzq) = kglcebgpqb fcvunubbkd (qdufomcshg ) View more	Positive	01 Aug 2022
				Placebo	-

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