New Executives Will Support Completion of APOLLOE4 Phase 3 Trial Evaluating Oral Tablet ALZ-801 (Valiltramiprosate) and Expansion of Product Portfolio
Strong Financial Position to Build World-Class Development and Commercial Organizations and Expand New Platform and Indication Opportunities
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 the appointments of Susan Flint as Vice President of Clinical Operations, Patrick Kesslak, PhD, as Vice President of Clinical Development & Medical Affairs, and Erwan de Naurois as Vice President of Finance.
“Our goal at Alzheon is to build the strongest data package to evaluate the therapeutic profile of oral tablet ALZ-801, deliver regulatory submissions, and support approval. In the first indication alone, we have an opportunity to provide a safe and effective treatment to millions of Alzheimer’s patients and open a path to treatment for the remaining Alzheimer’s populations, as well as healthy people at high risk for the disease,” said Martin Tolar, MD, PhD, Alzheon Founder, President, and Chief Executive Officer. “Our strong financial position following the completion of the Series D round and excitement from the announcement of industry-leading disease modifying effects in our Phase 2 biomarker trial of oral ALZ-801, attracted top talent to Alzheon to build world-class development and business organizations. With these new executives, we will accelerate development and commercialization of ALZ-801 and continue expansion into new platform and indication opportunities.”
Ms. Flint brings to Alzheon over 30 years of experience across the pharmaceutical industry, with a focus on drug development, clinical operations, and regulatory affairs. Ms. Flint has managed more than 75 clinical studies, including over 20 Phase 3 clinical trials, several of which led to product approval by the FDA. Previously, she led clinical operations at Wilson Therapeutics AB. Her expertise ranges from pre-IND to commercial stages of drug development, with a focus in neurological, rare, and orphan diseases. Ms. Flint received her Bachelor of Science in Biology at Bridgewater State College and her Master of Sciences in Pharmacology at Northeastern University, graduating summa cum laude from both programs.
“There is an unparalleled medical need for an Alzheimer’s treatment capable of slowing the course of disease progression. Particularly, one characterized by both efficacy and favorable safety,” said Susan Flint. “I am excited to be working on Alzheon’s National Institute on Aging-sponsored pivotal Phase 3 trial, with the goal of completing enrollment this year.”
Dr. Kesslak brings to Alzheon 20 years of experience in the biopharmaceutical industry with a focus on central nervous system disorders. His industry experience ranges from Phase 1 to Phase 3 studies, and commercial development in neurology and psychiatry. As a program lead, Dr. Kesslak advanced programs for the treatment of behavioral disorders in Alzheimer’s and Parkinson’s diseases. During his career, he has held positions with increasing levels of responsibility at Amgen, Allergan, Elan, Acadia, and most recently at Revance Therapeutics. Before joining industry, Dr. Kesslak practiced as a licensed clinical psychologist specializing in Alzheimer’s disease, dementia, and aging, and pursued basic research as associate professor at the University of California, Irvine (UCI). As a clinician and original member of the Institute for Brain Aging and Dementia at UCI, he was responsible for early studies on olfaction in Alzheimer’s, brain imaging, and clinical trials. Dr. Kesslak received his PhD in Psychology from Texas Christian University with a background in neuroscience, experimental, and clinical neuropsychology.
“Alzheon provides an innovative alternative to anti-amyloid antibodies and the recent biomarker and clinical results demonstrate the advantages of this approach,” said Patrick Kesslak, PhD. “With Phase 3 development in full swing and the Phase 2 biomarker trial running in parallel, I am incredibly excited to be a part of the team working to bring novel disease-modifying treatments to patients suffering from Alzheimer’s disease and other neurodegenerative disorders.”
Mr. de Naurois brings to Alzheon more than 15 years of experience in corporate strategy, financial planning, commercial development and partnering. He has delivered strategic initiatives, such as new product developments and launches, global commercialization, business acquisitions, divestitures, and operational turnarounds to a number of organizations. Mr. de Naurois has worked in leadership roles in companies across the life sciences and pharmaceutical sector, most recently at Flagship Pioneering. At Flagship, he led the implementation of systems to scale up operations of early-stage biotechnology companies and established and migrated financial functions of 7 spinouts. Mr. de Naurois holds degrees from Paris Nanterre University and Cranfield University, is a member of the Chartered Institute of Management Accountants, and a member of the Institute of Directors in the United Kingdom.
“The Alzheimer’s space is poised to have its most eventful year and Alzheon is leading the charge with oral tablet ALZ-801,” said Erwan de Naurois. “Our lead product, which inhibits the toxic oligomerization of beta amyloid protein and keeps them in their healthy monomeric form, has been shown to slow the downstream pathology and cognitive decline of AD patients. I am thrilled to join this team as we work to provide relief to patients with Alzheimer’s disease and hope to their families and loved ones.”
ALZ-801 is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD.1,3 In mechanism of action studies, ALZ-801 has been shown to fully inhibit the formation of neurotoxic soluble 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 of cognitive symptoms and progression of AD.1–4 ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017. The clinical data for ALZ-801 and Alzheon’s safety database indicate a favorable safety profile.5–7,9 The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with the APOE4/4 genotype, with future expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.1–4
ALZ-801 APOLLOE4 Phase 3 Study
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220): This ongoing study 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 the APOE4/4 genotype, 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 $47 million grant from the National Institute on Aging.
ALZ-801 Phase 2 Biomarker Study
Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease (NCT04693520): This ongoing study is designed to evaluate the effects of 265 mg twice daily oral dose of ALZ-801 on biomarkers of Alzheimer's pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotypes, who together constitute 65-70% of Alzheimer's patients. The study also includes evaluation of clinical efficacy, safety, and tolerability of ALZ-801 over 104 weeks of treatment and will evaluate the extended pharmacokinetic profile of ALZ-801 over 8 hours in 24 subjects after 65 weeks of treatment.
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 devastating neurodegenerative disorders. Our lead Alzheimer’s clinical candidate, ALZ-801, is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. 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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