Alzheon CEO Dr. Martin Tolar Awarded Eliška and Zdeněk Strmiska Award from Alzheimer’s Foundation for Significant Contribution Towards Research and Treatment of Alzheimer’s Disease, and Donated Cash Prize to INDRC Institute

• Alzheimer’s Foundation Recognized Impact of Dr. Tolar’s Scientific Discoveries in Advancing Understanding of Alzheimer’s that Led to Development of Oral Disease Modifying Treatment ALZ-801/Valiltramiprosate
• Dr. Tolar Donated Cash Portion of Award to International Neurodegenerative Disorders Research Center (INDRC) to Accelerate Identification of Treatments for Neurodegenerative Disorders by Applying Data Driven Solutions
• INDRC Pioneers Combination of Biological Sciences and Medicine with Big Data and Artificial Intelligence Approaches to Identify Therapeutic Interventions for Alzheimer’s Disease and Other Neurodegenerative Disorders

FRAMINGHAM, Mass.--(BUSINESS WIRE)-- Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that its Founder, President & CEO Dr. Martin Tolar has been awarded the Eliška and Zdeněk Strmiska Award from the Alzheimer’s Foundation for significant contribution towards the research and treatment of Alzheimer’s disease.

“Dr. Martin Tolar’s lifetime contributions towards the understanding of Alzheimer’s disease and neurodegeneration, including how we define and treat Alzheimer’s disease, and how each therapeutic candidate in development fits into the future landscape of treatment options, has had a remarkable impact on leading us to where we are today: finally bringing to patients and their families therapies that can slow the course of this devastating disease,” said Šárka Kovandová, Director of Alzheimer’s Foundation. “With the latest advancements of the ALZ-801 oral treatment program that Dr. Tolar has led as well as the founding of the INDRC institute that leverages artificial intelligence and machine learning solutions to identify therapeutic interventions for Alzheimer’s disease, Dr. Tolar was the clear choice for this award.”

The Alzheimer’s Foundation was founded in 2011 to support the research of Alzheimer’s disease and other neurodegenerative and vascular brain disorders, which lead to deficit in cognitive function and dementia. In addition to supporting research both in the Czech Republic and abroad, the Foundation aims to improve the quality and conditions of local patient care and broaden the scope of care provided.

Since 2017, thanks to the generous gift from the Eliška Strmiska, the Alzheimer’s Foundation has given the Eliška and Zdeněk Strmiska Award to someone who has made an outstanding and significant contribution to the research and treatment of Alzheimer’s disease and related neurodegenerative diseases. The winner receives 100,000 Czech crowns as an award for their work to date and as motivation for the coming years.

Dr. Tolar donated the cash portion of his award to the INDRC, International Neurodegenerative Disorders Research Center, an institute focused on establishing a framework around the current theories of Alzheimer’s disease, building a complete brain architecture with a common ontology, creating a knowledge management platform to streamline data analyses, constructing a repository of artificial intelligence (AI) models that enable new discoveries, and developing new methods and models to enable exploration of complex data.

The INDRC institute is a private, non-profit, global research institute based in Prague, Czech Republic, that for the first time combines biological sciences and medicine with big data and AI approaches to study and treat Alzheimer’s disease and other neurodegenerative disorders. The INDRC goal is to merge and advance the globally dispersed knowledge in brain systems and neurodegeneration through research training, fellowship programs of excellence, delivering outstanding independent research programs, building a world-class Scientific Advisory Board and research community, and enabling technological and therapeutic innovations with genuine impact on society and humanity. INDRC is interdisciplinary by design, addressing research bottlenecks and developing new analytical approaches to discover and model the non-linear dynamics between biology, disease, man, and environment. The Institute uses a transparent governance model that includes committed international partners from the European Union, North America and around the world, including universities, research institutes, clinical centers, and for-profit/non-profit companies. INDRC projects apply artificial intelligence and machine learning to address the challenges facing the identification and validation of new therapeutic interventions in Alzheimer’s and other neurodegenerative disorders to advance therapies with the greatest impact for patients.

“We are thankful for Dr. Tolar’s leadership in not only founding the INDRC institute, but also the tremendous insights he has generated during his work in academia and life science companies that have advanced our understanding of Alzheimer’s disease. His vision enabled INDRC to develop AI methodologies that can leverage the vast information available to researchers today, who need help in contextualizing and interpreting these data,” said Lenka Uldrijanová, Executive Director of INDRC. “The INDRC institute is grateful to apply the funds from Dr. Tolar’s award towards advancing its mission of fostering breakthroughs in the treatment and prevention of Alzheimer’s disease and other neurodegenerative disorders.”

Dr. Martin Tolar founded Alzheon in 2013 to improve the understanding of the biology driving neurodegeneration and to develop new interventions to prevent and treat neurodegenerative disorders and serves as its President & CEO. In 2021, Dr. Tolar founded the INDRC institute with the mission to address the lack of understanding of the complex interrelationship between brain structure and brain function, as well as limited knowledge of the precise pathogenic pathways that impair or destroy neurons and their connections, using big data and AI approaches, and serves as Chairman of its Executive Board. Dr. Tolar also serves on the Alzheimer’s Disease Discovery Foundation’s Scientific Review Board and has received the Czech Laurels Award from the Czech Chamber of Commerce in recognition of his leadership in Alzheimer’s disease therapeutics. Prior to Alzheon, Dr. Tolar held leadership positions in multiple life sciences companies, and served as an Assistant Professor of Neurology at the Yale University School of Medicine. Dr. Tolar trained in Neurology at the Boston Medical Center, received a Ph.D. in Neuroscience for his work on the role of apolipoprotein E in pathogenesis of Alzheimer’s disease and his M.D. from Charles University in Prague.

“I am honored to be recognized for this prestigious award and pleased to accept the prize on behalf of the Alzheon team. Seminal Alzheon discoveries over the past decade and progress in developing the ALZ-801 tablet, which acts upstream on the same pathway as the currently approved anti-amyloid antibodies, mean that a positive readout next summer may enable us to bring the first oral agent that can alleviate Alzheimer’s pathology to patients and healthy individuals at risk for the disease,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon. “The pioneering work we are doing at the INDRC institute, applying the latest AI and machine learning solutions, provides a robust platform for new discoveries and enables us to learn from and build upon the progress we have made in Alzheimer’s drug development.”

About ALZ-801

ALZ-801/valiltramiprosate is an investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD.^1,3 ALZ‑801 is designed to block the formation of neurotoxic soluble beta amyloid oligomers causing cognitive decline in Alzheimer’s patients. In mechanism of action studies, ALZ-801 has fully inhibited the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose.^5,6 ALZ‑801 acts through a novel enveloping molecular mechanism of action to fully block formation of neurotoxic soluble amyloid oligomers in the human brain⁷ associated with the onset and progression of cognitive decline in AD patients.^1–4 ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017 for Alzheimer’s disease. In clinical trials, ALZ-801 has shown favorable safety results.^5–7,9 The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with the APOE4/4 genotype, with potential future program expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.^1–4

ALZ-801 Phase 2 Biomarker Trial

Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer’s Disease (NCT04693520): This ongoing trial was designed to evaluate the effects of 265 mg twice daily oral dose of ALZ-801 on biomarkers of AD pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotype and constitute 65-70% of Alzheimer’s patients. The trial also included evaluation of clinical efficacy, safety, tolerability, and pharmacokinetic profile of ALZ-801 over 104 weeks of treatment. An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 52 weeks of treatment for a total of 156 weeks.

ALZ-801 APOLLOE4 Phase 3 Trial

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer’s Disease Subjects (NCT04770220): This ongoing trial is designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of ALZ-801 in Early AD subjects with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who constitute approximately 15% of Alzheimer’s patients. This is a double-blind, randomized trial comparing oral ALZ-801 to placebo treatment over 78 weeks. The APOLLOE4 trial is supported by a $51 million grant from the National Institute on Aging.

About Alzheon

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of neurodegeneration. Our lead Alzheimer’s clinical candidate, ALZ-801/valiltramiprosate, is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that has been observed to fully block the formation of neurotoxic soluble amyloid oligomers in preclinical tests. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.

Alzheon Scientific Publications
¹ Tolar M, et al: Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression, International Journal of Molecular Sciences, 2021; 22, 6355.
² Abushakra S, et al: APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease Show Accelerated Hippocampal Atrophy and Cortical Thinning that Correlates with Cognitive Decline, Alzheimer’s & Dementia, 2020; 6: e12117.
³ Tolar M, et al: Aducanumab, Gantenerumab, BAN2401, and ALZ-801—the First Wave of Amyloid-Targeting Drugs for Alzheimer’s Disease with Potential for Near Term Approval, Alzheimer’s Research & Therapy, 2020; 12: 95.
⁴ Tolar M, et al: The Path Forward in Alzheimer’s Disease Therapeutics: Reevaluating the Amyloid Cascade Hypothesis, Alzheimer’s & Dementia, 2019; 1-8.
⁵ Hey JA, et al: Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain, CNS Drugs, 2018; 32(9): 849-861.
⁶ Hey JA, et al: Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease, Clinical Pharmacokinetics, 2018; 57(3): 315–333.
⁷ Abushakra S, et al: Clinical Effects of Tramiprosate in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease Suggest Disease Modification Potential, Journal of Prevention of Alzheimer’s Disease, 2017; 4(3): 149-156.
⁸ Kocis P, et al: Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data, CNS Drugs, 2017; 31(6): 495-509.
⁹ Abushakra S, et al: Clinical Benefits of Tramiprosate in Alzheimer’s Disease Are Associated with Higher Number of APOE4 Alleles: The “APOE4 Gene-Dose Effect,” Journal of Prevention of Alzheimer’s Disease, 2016; 3(4): 219-228.

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