Vivoryon Therapeutics N.V. Provides Update on VIVIAD Phase 2b Study of
Varoglutamstat in Early Alzheimer's Disease
* VIVIAD Phase 2b study did not meet its primary and key secondary endpoints
* Varoglutamstat was generally well tolerated with low discontinuation rates
due to adverse events and no evidence of symptomatic ARIAs in the clinical
setting
* VIVIAD is a comprehensive, diligently designed and high-quality study;
baseline demographics in the study were highly representative of early AD
patient population
* Company is conducting an in-depth analysis of the results, including
analyses of additional pre-specified and exploratory endpoints
* Further update expected to be provided no later than with publication of
Company's full year 2023 financial results
Halle (Saale) / Munich, Germany, March 4, 2024 - 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 announced
topline results from its Phase 2b European VIVIAD study of varoglutamstat
(PQ912), an investigational oral glutaminyl cyclase (QPCT) inhibitor in
development for the treatment of early Alzheimer's disease (AD). The VIVIAD
study did not meet its primary endpoint and did not show a statistically
significant difference in change over time on cognition, as measured by a
combined score (Z-score) of the Detection test, the Identification test and the
'One Back' test (attention and working memory domains) of the Cogstate
neuropsychological test battery (NTB), called "Cogstate 3-item scale".
Additionally, the study did not meet key secondary endpoints measuring cognition
(Cogstate Brief Battery, CBB, and complete Cogstate NTB), Instrumental
Activities of Daily Living Questionnaire (A-IADL-Q) and electroencephalogram
(EEG) global theta power. Varoglutamstat was generally well tolerated and showed
rates similar to placebo of serious and severe treatment emergent adverse events
(TEAEs), low discontinuation rates due to adverse events and no evidence of
symptomatic ARIAs (amyloid-related imaging abnormalities) in the clinical
setting.
The Company is conducting an in-depth analysis of the results, including
analyses of additional pre-specified exploratory endpoints (e.g. WAIS-IV coding
test, executive function and episodic memory domains, Winterlight Labs speech
assessment, cerebrospinal fluid (CSF) biomarkers and additional EEG analysis)
and distinct patient cohorts as defined in the statistical analysis plan,
including ApoE4 status, tau level, dose level and pre-treatment.
"We are profoundly disappointed by the outcome of the VIVIAD Phase 2b study of
varoglutamstat in the early AD patient population given the huge unmet need for
new safe and effective oral therapies," said Frank Weber, M.D., CEO of Vivoryon.
"I would like to express our gratitude to the patients, their families and
caregivers, as well as the investigators for participating in the VIVIAD study,
and to our incredible team at Vivoryon for their tireless efforts. While these
results are not what we had hoped for, VIVIAD is a comprehensive, diligently
designed and high-quality study and we are doing all we can to fully analyze the
dataset as quickly as possible to gain insights into key findings that might
influence varoglutamstat clinical development and help advance the science and
understanding of this devastating disease."
A further update is expected to be provided no later than with the publication
of the Company's full year 2023 financial results which are expected in mid to
late April 2024.
###
About Varoglutamstat
Varoglutamstat (PQ912) is a differentiated oral small-molecule targeting the
toxic Abeta species N3pE which is being developed as disease-modifying therapy
and is designed to target AD pathology upstream of Abeta-antibody focused
approaches. Varoglutamstat blocks the enzyme glutaminyl cyclase (QPCT) and its
isoenzyme QPCTL. QPCT catalyzes the formation of N3pE amyloid, a particularly
neurotoxic variant of Abeta peptides, which is only found in patients with AD
and not present in the brains of healthy individuals. N3pE amyloid in the brain
acts as a seeding element for Abeta aggregation, thus providing a starting point
for plaque formation. It has been described to correlate with the cognitive
ability of patients with AD. Beyond Abeta pathology, varoglutamstat has also
been shown to impact synaptic impairment. Through a second mode of action, the
inhibition of full CCL2 maturation via QPCTL, varoglutamstat modulates pro-
inflammatory signaling and tau pathology, thereby simultaneously addressing
multiple hallmarks of AD. Vivoryon has received Fast Track designation for
varoglutamstat in early AD by the U.S. Food and Drug Administration (FDA). It is
being investigated in two Phase 2 clinical studies, one in Europe (VIVIAD,
NCT04498650) and one in the U.S. (VIVA-MIND, NCT03919162). Varoglutamstat has
not yet been approved by any regulatory authority and the safety and efficacy
have not yet been established.
About VIVIAD
VIVIAD is a state-of-the-art Phase 2b study conducted in Europe and designed to
evaluate the safety, tolerability, and efficacy of varoglutamstat in 259
participants with mild cognitive impairment (MCI) and mild AD (collectively
referred to as "early AD"). The primary endpoint is the change over time on
working memory and attention as measured by a combined score (Z-score) of the
Detection test, the Identification test and the 'One Back' test (attention and
working memory domains) of the Cogstate neuropsychological test battery (NTB),
called "Cogstate 3-item scale". Key secondary efficacy endpoints include in
hierarchical order: Cogstate Brief Battery (CBB, 4-item scale), the complete
Cogstate NTB (8-item scale), the Amsterdam Instrumental Activities of Daily
Living Questionnaire (A-IADL-Q), and electroencephalogram (EEG) global theta
power.
About Vivoryon Therapeutics N.V.
Vivoryon is a clinical stage biotechnology company focused on developing
innovative small molecule-based medicines. Driven by our passion for ground-
breaking science and innovation, we strive to change the lives of patients in
need suffering from severe diseases. We leverage our in-depth expertise in
understanding post-translational modifications to develop medicines that
modulate the activity and stability of proteins which are altered in disease
settings. Beyond our lead program, varoglutamstat, which is in Phase 2 clinical
development to treat Alzheimer's disease, we have established a solid pipeline
of orally available small molecule inhibitors for various indications including
cancer, inflammatory diseases and fibrosis. www.vivoryon.com
(http://www.vivoryon.com)
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 the Vivoryon Therapeutics N.V. (the
"Company"), estimates and projections with respect to the market for the
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"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 as well as on evaluations made by the Company of
estimates, projections and other statistical data made by independent third
parties. 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. Actual results, performance 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:
Investor Contact
Stern IR
Penelope Belnap
Tel: +1 212-362-1200
Email: penelope.belnap@sternir.com (mailto:penelope.belnap@sternir.com)
Media Contact
Trophic Communications
Stephanie May
Tel: +49 171 1855682
Email: vivoryon@trophic.eu (mailto:vivoryon@trophic.eu)
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