Vivoryon Therapeutics N.V. 提供有關Varoglutamstat臨床計劃進展的全面進度報告,隨著R&D活動和VIVA-MIND DSMB劑量決定

Vivoryon Therapeutics N.V. Provides Comprehensive Progress Report for Ongoing Varoglutamstat Clinical Program Following R&D Event and VIVA-MIND DSMB Dose Decision

  • Both VIVIAD and VIVA-MIND progressing at 600mg twice daily with oral administration following two independent positive DSMB decisions
  • Varoglutamstat demonstrates very encouraging safety data with no evidence of drug-related ARIAs at therapeutic dose of 600mg twice daily, a dose demonstrated to result in nearly 90% target occupancy
  • On track to report final VIVIAD Phase 2b readout in Q1/2024
  • Commenced preparations for open label extension study to provide long-term treatment option to patients after completion of treatment under VIVIAD or VIVA-MIND
  • Company to participate at upcoming Jefferies London Healthcare Conference taking place November 14-16, 2023

Halle (Saale) / Munich, Germany, October 26, 2023 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today provided a comprehensive overview of the progress of the ongoing clinical development of varoglutamstat, an orally administered novel small molecule. Varoglutamstat’s mid to late-stage clinical studies, VIVIAD and VIVA-MIND, evaluating its potential to treat early Alzheimer’s disease (AD), are comprised of a broad range of key primary and secondary endpoints covering cognition, function and neuronal connectivity.

“The breadth and significance of data collected thus far from varoglutamstat’s clinical development program further expands our understanding of early AD pathology and treatment. With independent DSMB dose decisions for both of our ongoing Phase 2 studies across multiple geographies and different titration regimens, varoglutamstat, has been cleared from a safety and tolerability standpoint to proceed with the highest investigated dose of 600mg twice daily. By evaluating varoglutamstat in two parallel clinical studies with varying efficacy endpoints, we can meaningfully support our regulatory strategies and provide a clear picture of the cognitive changes potentially resulting from treatment on study. Utilizing a stepwise methodology for clinical development, we have been able to create a statistically robust trial setting in VIVIAD with the intent of VIVA-MIND designed to confirm the findings of VIVIAD,” said Frank Weber, M.D., CEO of Vivoryon. “Building upon the positive findings from the SAPHIR Phase 2a study, we have meticulously designed VIVIAD and VIVA-MIND, grounded in the understanding that N3pE-Abeta presence has been identified in and beyond plaques, in the synaptic space of neurons and within their cell walls. Varoglutamstat has shown convincing results of neuronal recovery after only 12 weeks of treatment, which supports our belief in the advantages of this mechanism of action to substantially reduce the production of N3pE-Abeta, rather than increase the clearance once synthesized and deposited in the plaque. Together, SAPHIR, VIVIAD and VIVA-MIND culminate in an immensely comprehensive Phase 2 clinical development program in early AD conducted so far with a planned total of nearly 800 patients. The program is further supported by varoglutamstat’s Fast Track designation granted by the FDA. Vivoryon is committed to improving the daily lives of patients with early AD and their families and we look forward to our imminent, final study readout from VIVIAD in the first quarter of 2024 at which point we intend to share final topline data, with the full dataset to be presented at a subsequent medical meeting.”


  • 經過吡咯基修飾的Abeta(N3pE-Abeta)是阿茲海默症病理與毒性的誘發因子,以目標N3pE-Abeta可以創造一個定制的阿茲海默症治療。
  • 實驗數據顯示,N3pE-Abeta與其他Abeta變體在物理化學性質上有很大不同,包括其形成高度毒性的聚集體與纖維,與非修飾Abeta變體一起。
  • 強大的前臨床證據支持通過抑制酵素QPCT來減少N3pE-Abeta形成,可能改變阿茲海默症進程的假設。


VIVIAD (NCT04498650)是一項在歐洲進行的IIb期研究,旨在評估259例輕度認知障礙(MCI)和輕度阿茲海默症患者使用Varoglutamstat後的安全性、耐受性和療效。主要療效端點是Cogstate神經心理測試組合(NTB)的「Cogstate 3項指標」,包括辨識、檢測和一次回憶測試,評估48-96周內的注意力和工作記憶領域。關鍵次要療效端點依次包括:Cogstate簡短測試組合(CBB,4項指標)、完整的Cogstate NTB(8項指標)、阿姆斯特丹日常活動能力量表(A-IADL-Q)以及腦電圖(EEG)。

  • Cogstate 3項指標(辨識、檢測、一次回憶)作為主要端點的目的是確認SAPHIR研究中觀察到的工作記憶和注意力方面的正面發現。
  • CBB(3項指標加一次卡片學習)已被稱為Cognigram,並獲得美國食品藥品監督管理局(FDA)及多個監管機構批准用於評估早期阿茲海默症患者的認知能力。
  • 完整的Cogstate NTB(8項指標)能夠評估各種認知領域的結果。
  • A-IADL-Q是一個完全驗證並對早期阿茲海默症患者日常功能減退敏感的量表。
  • 腦電圖可以捕捉大規模神經元和突觸活動的變化。θ波功率已被選為關鍵次要療效端點,因為它與工作記憶密切相關。