Alzheon
Founder, President & CEO
Dr. Tolar serves as Founder President & CEO of Alzheon. Prior to founding Alzheon in June 2013, Dr. Tolar held executive positions in several life sciences companies, where he has successfully established and grew new companies, business areas and product opportunities. Dr. Tolar served as President & CEO of Knome, Inc., where he led the development of human genome interpretation systems and services for academic, pharmaceutical and clinical clients, as President & CEO at NormOxys, Inc., where he built the business for novel cancer therapeutics, and as Chief Scientific Officer and Chief Business Officer at CoMentis, Inc., where he developed the first clinical-stage beta secretase inhibitor platform for Alzheimer’s disease and negotiated a collaboration with a potential value of $1.1 billion with Astellas Pharma in 2008. Dr. Tolar held a variety of clinical development and business leadership positions at Pfizer, where he was instrumental in a wide range of business transactions, including acquisition of Rinat Neuroscience for $500 million in 2006, and directed programs through all stages of clinical development and FDA approval including NDA filings.
During his academic career, Dr. Tolar served as an Assistant Professor in the Department of Neurology at Yale University School of Medicine, where he focused on movement disorders. 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 Alzheimer’s disease, and published many scientific publications in the area of neuroscience and neurodegenerative disorders. Dr. Tolar received his M.D. from Charles University in Prague, where, as a medical student, he helped organize and lead the Velvet Revolution that toppled the communist regime in the former Czechoslovakia in November 1989.
Dr. Tolar serves on business and scientific boards including the Alzheimer’s Drug Discovery Foundation, the Alzheimer Foundation and Advance Healthcare Management Institute.
Dr. Tolar was recognized as one of the Top 100 Most Influential People in the world of drug development and manufacture by The Medicine Maker Magazine’s Power Lists for 2016, 2017, 2018 and 2019. In 2021, Dr. Tolar received the Czech Laurels Award from the Czech Chamber of Commerce in recognition of his leadership in Alzheimer disease therapeutics, as well as clinical, scientific, and business projects in the Czech Republic built by Alzheon. The Czech Chamber of Commerce is the largest and the most representative business association in the Czech Republic.
Presenter of 1 Presentation
INTERIM RESULTS FROM PHASE 2 BIOMARKER STUDY WITH ORAL ANTI-AMYLOID AGENT ALZ-801: PLASMA BIOMARKERS IN APOE4 CARRIERS WITH EARLY ALZHEIMER’S DISEASE
Session Type
SYMPOSIUM
Date
Thu, 17.03.2022
Session Time
05:15 PM - 07:15 PM
Room
ONSITE: 114
Lecture Time
06:30 PM - 06:45 PM
Presenter
Abstract
Abstract Body
BackgroundThe core Alzheimer’s disease (AD) biomarkers, beta-amyloid and hyperphosphorylated tau (Aβ, p-tau), are useful in evaluating disease-modifying agents. ALZ-801, an oral, brain-penetrant, amyloid oligomer inhibitor, is evaluated as a disease-modifying treatment in two ongoing Early AD trials: Phase 2 study in APOE4 carriers and APOLLOE4 Phase 3 study in APOE4/4 homozygotes.
Objectives
Report preliminary 26-week results of plasma biomarkers and cognitive tests of the Phase 2 trial.
Methods
The ongoing Phase 2 biomarker study enrolled APOE4 carrier Early AD subjects (N=84) with A+/T+ CSF biomarkers, who receive ALZ-801 at 265mg BID for 2 years. The pre-specified primary analysis at 13 and 26 weeks is plasma p-tau181, with secondary cognitive outcomes. Biomarker analyses were performed, blinded to clinical information, at the Clinical Neurochemistry Laboratory, Gothenburg University, Sweden.
Results
In 80 patients (69 years, 51% female), who completed 26 weeks of treatment, significant mean reductions from baseline were seen at Week 13 and Week 26 timepoints: p-tau181 18% (p=0.038) and 29% (p=0.028); and p-tau181/Aβ42 21% (p=0.018) and 30% (p=0.022). The Rey Auditory Verbal Learning Test total memory scores (immediate + delayed) improved significantly at Week 26 (p=0.002). In 84 subjects, the most common adverse event was mild nausea, with no drug-related serious events and no evidence of vasogenic edema.
Conclusions
Preliminary analyses from Phase 2 trial show robust reductions in plasma p-tau181 and p-tau181/Aβ42 with memory improvement at 26 weeks. These results confirm target engagement of ALZ-801 in AD brain, and support disease modifying effects of ALZ-801 on core AD pathologies.