预约演示
更新于：2026-03-30
PRI-002
更新于：2026-03-30
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C55H78O4 |
InChIKeyBINXWQZTCIKYFR-UWKHKGTHSA-N |
CAS号1271740-13-6 |
关联
5
项与 PRI-002 相关的临床试验NCT06182085
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)
CTIS2022-503148-41-00
Randomised, 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)
NCT04711486
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
100 项与 PRI-002 相关的临床结果
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100 项与 PRI-002 相关的转化医学
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100 项与 PRI-002 相关的专利（医药）
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38
项与 PRI-002 相关的文献（医药）2025-12-01Alzheimers & 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
作者: Brener, Alexander ; Tischler, Gerhard ; Kauselmann, Gunther ; Peters, Oliver ; Lindner, Katja ; Adermann, Knut ; Gabelich, Julie‐Anne ; Jürgens, Dagmar ; 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.
2025-07-01ANTICANCER RESEARCH
Resveratrol Derivatives Inhibit Pro-survival Akt Signaling Pathway in Lung Cancer
Article
作者: Innets, Bhurichaya ; Racha, Satapat ; Sriratanasak, Nicharat ; Ei, Zin Zin ; Chanvorachote, Pithi
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.
2024-06-01British Journal of Pharmacology
An orally available Cav2.2 calcium channel inhibitor for the treatment of neuropathic pain
Article
作者: 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.
100 项与 PRI-002 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 阿尔茨海默症 | 临床2期 | 捷克 | 2023-12-01 | |
| 阿尔茨海默症 | 临床2期 | 德国 | 2023-12-01 | |
| 阿尔茨海默症 | 临床2期 | 意大利 | 2023-12-01 | |
| 阿尔茨海默症 | 临床2期 | 荷兰 | 2023-12-01 | |
| 阿尔茨海默症 | 临床2期 | 波兰 | 2023-12-01 | |
| 阿尔茨海默症 | 临床2期 | 西班牙 | 2023-12-01 | |
| 轻度认知障碍 | 临床2期 | 捷克 | 2023-12-01 | |
| 轻度认知障碍 | 临床2期 | 德国 | 2023-12-01 | |
| 轻度认知障碍 | 临床2期 | 意大利 | 2023-12-01 | |
| 轻度认知障碍 | 临床2期 | 荷兰 | 2023-12-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | - | 300 | 鹹繭積簾醖衊獵餘鑰餘(窪衊鬱願鹹範廠糧窪餘) = 獵憲繭範膚餘憲膚網齋 窪鑰顧憲製夢艱鑰窪艱 (憲願糧鏇鏇築獵廠獵鹹 ) | 积极 | 2025-12-01 | ||
蓋襯選顧願選範獵衊餘(構壓夢壓淵淵夢餘積觸) = 襯範淵積鏇構鹽鑰蓋窪 餘範蓋糧蓋鹹製鑰鹹壓 (廠鑰繭獵願艱鹽壓遞夢 ) 更多 | |||||||
临床1期 | Aβ1-42 | Aβ oligomers | 20 | 簾繭範獵齋鑰獵醖糧鏇(鑰淵獵艱憲蓋鑰壓獵醖) = 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. 齋夢繭鏇襯淵選憲遞艱 (襯製壓鏇醖夢廠鏇膚鏇 ) 更多 | 积极 | 2022-12-03 | ||
Placebo | |||||||
临床1期 | 19 | PRI-002 300 mg | 淵淵築範選鹹鏇壓顧鑰(簾襯窪築鬱鹹鏇獵顧糧) = 遞醖鹽餘夢網壓簾顧獵 築遞衊獵簾艱醖鹹築襯 (範餘襯簾築齋網壓淵構 ) 更多 | 积极 | 2022-08-01 | ||
Placebo | - |
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