A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912) in Patients With Early Alzheimer's Disease With a Stage-Gate to Phase 2B (VIVA-MIND)

This is a Phase 2A multi-center, randomized, double blind, placebo-controlled, parallel group study of varoglutamstat, with a stage gate to Phase 2B.
In Phase 2A there will be adaptive dosing evaluation of three dose levels with exposure to varoglutamstat or placebo for a minimum of 24 weeks, with preliminary evaluation of both cognitive function and pharmacodynamic changes on EEG spectral analysis in approximately 180 participants.
In the event that the stage gate for Phase 2B is reached, then Phase 2B will assesses efficacy and longer-term safety in a larger study group, i.e., 414.

Start Date15 Nov 2021

Sponsor / Collaborator

Vivoryon Therapeutics NV

[+1]

NCT02389413

/ CompletedPhase 2

A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease

The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.

Start Date01 Mar 2015

Sponsor / Collaborator

Vivoryon Therapeutics NV

[+1]

NCT02190708

/ CompletedPhase 1

A Phase I, Open Label Study to Assess the Effects of PQ912 on the Pharmacokinetics of Midazolam and Omeprazole in Healthy Male Subjects

Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours) and is primarily metabolised by CYP3A.
Omeprazole is a selective proton pump inhibitor substrate used to reduce gastric acid secretion. Omeprazole is primarily metabolised by CYP2C19.
Midazolam and omeprazole are both used as probe drugs in clinical pharmacology studies to evaluate clinical CYP3A and CYP2C19 drug interactions, respectively. Furthermore the EMA and the FDA guidance on drug interactions recommend the use of these drugs for such evaluations.
The aim of this study is to assess the effect of PQ912 on the PK of midazolam and omeprazole. In vitro studies have demonstrated that PQ912 inhibits several CYP enzymes, including CYP3A4 and CYP2C19 and at the expected exposure levels in patients, has the potential to inhibit these enzymes in-vivo. This study is therefore planned to investigate the potential changes in the PK of midazolam and omeprazole due to the effect of PQ912 at steady-state. In clinical practice it is likely that co-administration of PQ912 with other drugs that are metabolised via the CYP3A and/or CYP2C19 enzymes will occur. This study will provide important information for the requirement of dose adjustments or contraindications in these circumstances.

Start Date01 Jun 2014

Sponsor / Collaborator

Vivoryon Therapeutics NV

[+1]

100 Clinical Results associated with Varoglutamstat

100 Translational Medicine associated with Varoglutamstat

100 Patents (Medical) associated with Varoglutamstat

Literatures (Medical) associated with Varoglutamstat

01 Dec 2025·Alzheimers & Dementia

Generalizability of digital speech and language assessments in MCI/mild AD across four non‐English languages

Article

Author: Schaeffer, Michael ; Xu, Mengdan ; Cormack, Francesca K ; Wenzkowski, Christine ; Lillo, Martina De ; Fuchs, Katharina ; Spilka, Michael J. ; Robin, Jessica

Abstract:

Background:

Neurodegenerative diseases affect speech production. Previous studies show various acoustic and linguistic changes in Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD) speech patterns, such as more pauses and lower usage of nouns. However, most research has focused on English speakers. This analysis examines speech features in MCI and AD patients across four languages to determine if digital speech assessments yield comparable results across different languages.

Method:

This study included 244 patients with MCI or mild AD enrolled in the Phase 2b VIVIAD trial of varoglutamstat, in four language groups: Danish ( n =84), German ( n =59), Dutch ( n =40), and Spanish ( n =61). A picture description task was administered to all patients at baseline using instructions in their respective languages. Five speech features including number of picture objects described, number of nouns, speech rate, pronoun‐to‐noun ratio and average of word length were chosen based on previous analyses of speech patterns in MCI/AD, and a composite score was calculated combining the five measures. We tested the interrelationships among the features in each language and examined whether the speech features were related to another measure of cognitive function, the Mini‐Mental State Exam (MMSE). Associations were examined using a correlational approach.

Result:

There was variation in the magnitudes of the correlations between speech features in the different languages, but the directions of the associations were generally consistent across the four languages in the study. In all four languages, significant correlations with the MMSE were found with both the composite score (‐0.46 ≤ r ≤ ‐0.26) and the object content score (0.27 ≤ r ≤ 0.42).

Conclusion:

Together, these results indicate that there are consistent interrelationships among different speech features across languages. In addition, in the four languages examined, the speech composite score and the number of objects correctly described related to a standard measure of cognition, the MMSE. These results suggest that digital measures of speech and language in MCI/AD are generalizable across languages and relate to cognitive ability more generally. In addition, a composite score of multiple speech features may be more sensitive to cognitive impairment than individual speech metrics.

01 Dec 2025·Alzheimers & Dementia

The VIVA‐MIND study: Topline Results from Phase 2 RCT of Varoglutamstat in Early AD

Article

Author: Messer, Karen ; Lama, Nicola ; Revta, Carolyn ; Weber, Frank ; Balasubramanian, Archana ; Edland, Steven D ; Wenzkowski, Christine ; Pol, Alessandra ; Jacobs, Diane M. ; Meyer, Antje ; Wassmann, Tanja ; Duehring, Jasmin ; Schell‐Mader, Sylvia ; Leger, Gabriel C ; Lupo, Jody‐Lynn ; Zhang, Jing ; Schaeffer, Michael ; Feldman, Howard H. ; MacKelfresh, Andrew ; Quach, Natalie E

Abstract:

Background:

Varoglutamstat (PQ912) is an oral small molecule inhibitor of glutaminyl cyclases which reduces the pyroglutamate formation of Aβ and CCL2. Preclinical and Ph1 trials support this Ph2 evaluation in early AD. Our objectives included selecting the highest safe and well‐tolerated dose of varoglutamstat with futility analysis at 24 weeks (Ph2A) followed by seamless evaluation of longer‐term safety and efficacy at 72 weeks at this dose (Ph2B).

Method:

Participants with biomarker confirmed early AD were randomized to varoglutamstat or placebo. A sequential design tested 3 descending doses (600mg, 300mg, 150mg BID) using a continuous Pocock safety boundary. A Stage Gate futility analysis of the first 180 subjects at 24 weeks was designed to guide the decision from Ph2A‐B (Figure 1). The Ph2B primary endpoint was CDR‐sum‐of‐boxes (CDR‐SB), with secondary endpoints CFC2, ABC score, spectral EEG, FAQ, ADAS‐Cog‐13, and NPI.

Result:

Table 1 presents baseline characteristics of the 109 randomized and dosed participants. The first dose cohort of varoglutamstat 600mg or placebo did not cross the safety boundary in Ph2A, supporting this dose selection for all participants thereafter. An abbreviated futility analysis was conducted after the trial was terminated prematurely for administrative reasons, with the provisional result of ‘halt enrollment’(yellow) (Figure 1). There were 74% of participants who completed week 24 and 31% week 72 (Figure 2). There were no significant differences between varoglutamstat and placebo in LS mean squares from baseline to week 72 in CDR‐SB (‐0.05 [95% CI ‐1.03, 0.92]), CFC2 (0.97 [95% CI ‐3.34, 5.28]), ABC score (0.10 [95% CI ‐0.10, 0.30]), FAQ (‐0.60 [95% CI ‐4.22, 3.01]), ADAS‐Cog‐13 (2.03 [95% CI ‐2.29, 6.36]); or NPI (‐3.09 [95% CI ‐7.81, 1.62]). At least one TEAE during treatment was reported in 84.9% varoglutamstat and 76.8% placebo with treatment discontinuations due to AE 11.3% varoglutamstat and 3.4% placebo. Severe TEAEs occurred with similar frequencies across arms. Frequency of SAEs/AESIs was 18.9/1.9% varoglutamstat versus 8.9%/5.4% placebo.

Conclusion:

Varoglutamstat was safe and well‐tolerated in this VIVA‐MIND early AD RCT. Efficacy assessment did not demonstrate any significant treatment benefits however, the available sample was limited. Biomarker results and PK/PD are pending.

18 Sep 2025·JOURNAL OF PHYSICAL CHEMISTRY B

Varoglutamstat Inhibits the Dimerization of the Aβ_25–35 Fragment in Aqueous Solution

Article

Author: Van V. Vu ; Son Tung Ngo ; Trung Hai Nguyen ; Philippe Derreumaux ; Hoang Anh Nguyen

The self-aggregation of amyloid-beta (Aβ) peptides is strongly associated with Alzheimer's disease. In this study, the influence of the small varoglutamstat compound on the conformations of the FAβ_25-35 dimer was extensively characterized by using MD simulations. The influence of the ligand on the conformation of the FAβ_25-35 dimer was studied during the first 10.0 μs. However, its real influence was clarified when the trajectory was extended to 20.0 μs. This indicates that the investigation of a ligand inhibiting Aβ requires a longer MD simulation than previously thought. The ligand changes ensemble properties by reducing the formation of nonbonded intermolecular contacts and β-content. Although varoglutamstat has weak binding to the FAβ_25-35 dimer, the free energy landscape is impacted in shape, free energy barrier, and number of minima. Notably, it is found that the population of the amyloid-competent dimer structure is substantially reduced upon ligand addition. Furthermore, the change from β-hairpin conformation to antiparallel structure may occur through a transition state forming a random coil conformation.

News (Medical) associated with Varoglutamstat

30 Oct 2026

·www.biospace.com

Vivoryon Therapeutics N.V. to Report Q3 2026 Financial Results on November 5, 2026

Vivoryon Therapeutics N.V. to Report Q3 2026 Financial Results on November 5, 2026 Halle (Saale) / Munich, Germany, October 30, 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that it will publish its third quarter financial results for the period ended September 30, 2026 on Thursday, November 5, 2026. As part of its third quarter financial results, Vivoryon will provide a business update, including updated cash runway guidance. The Company’s key strategic priority remains securing the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced diabetic kidney disease, with the aim of confirming the compelling data observed in the VIVIAD and VIVA-MIND studies. Vivoryon has made further progress in its strategic partnering efforts and is engaged in advanced negotiations with different parties towards securing a partnership for varoglutamstat in kidney disease. In parallel, Vivoryon has implemented additional cost-saving measures aimed at preserving its financial resources while pursuing its strategic partnering activities. All ongoing negotiations and potential investments remain subject to the customary risks and uncertainties associated with such processes, and there can be no assurance that any transaction or investment will materialize. ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 20261030_NoR_Q3 2026

Financial StatementPhase 2

29 Sep 2026

·www.biospace.com

Vivoryon Therapeutics N.V. Reports Outcome of 2026 Annual General Meeting

Vivoryon Therapeutics N.V. Reports Outcome of 2026 Annual General Meeting Halle (Saale) / Munich, Germany, September 29 , 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, held its Annual General Meeting (AGM) today at 11:00 a.m. (CEST). The shareholders approved all items on the agenda of the meeting, including the appointment of Marcus Irsfeld, CFO of Vivoryon since December 2025, as well as the re-appointment of Dr. Frank Weber and Dr. Michael Schaeffer as executive directors to the Company’s Board. All documents relating to the AGM, including presentation and voting results, are available on the Company’s website: ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 2026-09-29_AGM 2026

Executive Change

18 Aug 2026

·www.biospace.com

Vivoryon Therapeutics N.V. to Hold its 2026 Annual General Meeting on September 29, 2026

Vivoryon Therapeutics N.V. to Hold its 2026 Annual General Meeting on September 29, 2026 Halle (Saale) / Munich, Germany, August 18, 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that its 2026 Annual General Meeting will be held on Tuesday, September 29, 2026, at 11:00 a.m. (CEST) at the Amsterdam offices of NautaDutilh N.V. The full agenda and all relevant documents are available on the Company's website: . ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 2026-08-17_AGM invitation PR

100 Deals associated with Varoglutamstat

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild dementia	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	26 Apr 2022
Mild dementia	Phase 2	China	Haupt Pharma Wülfing GmbH	26 Apr 2022
Mild dementia	Phase 2	China	Vivoryon Therapeutics NV	26 Apr 2022
Mild cognitive disorder	Phase 2	Denmark	Vivoryon Therapeutics NV	06 Jul 2020
Mild cognitive disorder	Phase 2	Denmark	Nordic Bioscience A/S	06 Jul 2020
Mild cognitive disorder	Phase 2	Germany	Nordic Bioscience A/S	06 Jul 2020
Mild cognitive disorder	Phase 2	Germany	Vivoryon Therapeutics NV	06 Jul 2020
Mild cognitive disorder	Phase 2	Netherlands	Vivoryon Therapeutics NV	06 Jul 2020
Mild cognitive disorder	Phase 2	Netherlands	Nordic Bioscience A/S	06 Jul 2020
Mild cognitive disorder	Phase 2	Poland	Nordic Bioscience A/S	06 Jul 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03919162 (VIVA-MIND, CTgov)	Phase 2	Alzheimer Disease	112	PQ912 (PQ912)	migdzxxkfc = ffhavdmhvk ryrnwdsyjv (lqhpeqmmve, savhhpeqwe - gxgwesoeta) View more	-	12 Dec 2025
				Placebo (Placebo)	migdzxxkfc = mznbgrqipn ryrnwdsyjv (lqhpeqmmve, hpftyayavf - zrxqgzanww) View more
NCT03919162 (VIVA-MIND, GlobeNewswire) Manual	Phase 2	Alzheimer Disease	-	Varoglutamstat	ruffintfuq(prpuuvxxym) = no clinically meaningful and no statistically significant differences between varoglutamstat 600mg BID and placebo qcuffzjzqo (osgugxztse ) View more	Positive	09 Dec 2024
				placebo
NCT04498650 (VIVIAD, ASN2024)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	259	Varoglutamstat 300 mg	bttrukjpqg(xmuwrtdhaf) = azgnisfmoj rztebmefnc (ikkgatsrlj )	Positive	25 Oct 2024
				Varoglutamstat 600 mg	wdtnzqbqga(nxwlxxcwot) = mueszgcrzu ywxourjuoa (kkqypqeisp ) View more
NCT04498650 (VIVIAD, GlobeNewswire \| ASN2024)	Phase 2	Alzheimer Disease \| Diabetic Nephropathies	32	Varoglutamstat	lganpgqfcv(pbaoudnmgy) = ibipmsvwno nxvzprnixf (tqcnnffoed )	Positive	25 Oct 2024
				placebo	lganpgqfcv(pbaoudnmgy) = lrpvrkhcfz nxvzprnixf (tqcnnffoed )
NCT04498650 (VIVIAD, GlobeNewswire) Manual	Phase 2	Kidney Diseases CCL2 Expression	-	Varoglutamstat 600mg BID	qmxbminpuq(avhcjojcsn) = udeuerkspg jcxlzxwljw (bjigzfxkxp ) View more	Positive	12 Sep 2024
NCT04498650 (VIVIAD, Corporate Publications) Manual	Phase 2	Alzheimer Disease	250	Varoglutamstat	maeekbnndz(itnmdovfsh) = qevpuogdpx xchqvpxqrc (hxwazmgxya ) View more	Positive	31 Jul 2022
NCT02389413 (Pubmed \| Alzheimers Res Ther) Manual	Phase 2	Alzheimer Disease	120	PQ912	jubwnqvslj(kybkynzpep) = There was no significant difference between treatments in the number of subjects with (serious) adverse events, although there were slightly more patients with a serious adverse event in the PQ912 group compared to placebo. mfdkobaxiv (bgijhxirbv ) View more	Positive	12 Oct 2018
				Placebo

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