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Cortexyme Assembles World Class Clinical Advisory Board to Support Its Alzheimer’s Disease Clinical Development Program

September 27, 2018

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep 27, 2018--Cortexyme, Inc., a clinical-stage pharmaceutical company developing therapeutics to alter the course of Alzheimer’s disease (AD) and other degenerative diseases, announced the formation of a new Clinical Advisory Board (CAB) in preparation for starting phase 2 clinical development in AD next year. The new CAB includes eight members with diverse backgrounds and expertise in Alzheimer’s, neurodegenerative disorders and drug development targeting the central nervous system (CNS): Mark Brody, M.D.; Martin Farlow, M.D.; Louis Kirby, M.D.; David Munoz, M.D.; Mark Ryder, D.M.D.; Marwan Sabbagh, M.D.; Eric Siemers, M.D.; and Stephen Thein, Ph.D. The group held its first meeting in Chicago ahead of the Alzheimer’s Association International Conference in July.

“We are thrilled to have attracted some of the world’s leading experts in Alzheimer’s disease to support Cortexyme as we develop our lead compound, COR388, which represents a completely new paradigm for potential disease modification in AD,” commented Samer Kaba, M.D., chief medical officer of Cortexyme. “The new Clinical Advisory Board complements our existing Scientific Advisory Board and comes as Cortexyme prepares for phase 2 efficacy trials of COR388 in AD to start next year.”

“COR388 has a novel mechanism of action with the potential to slow or stop progression of Alzheimer’s disease,” said Dr. Marwan Sabbagh, M.D., a member of the CAB and the director of the Cleveland Clinic Lou Ruvo Center for Brain Health. “I look forward to working with my colleagues on the Clinical Advisory Board to advise Cortexyme on the development and execution of phase 2 clinical development activities to comprehensively evaluate this new and promising small molecule.”

“The membership of our Clinical Advisory Board speaks to the scientific and clinical enthusiasm for Cortexyme’s unique therapeutic approach to Alzheimer’s disease, and to the potential of COR388 in particular,” said Casey Lynch, co-founder and chief executive officer of Cortexyme. “We are grateful for the Board’s contributions as we work to quickly advance new therapies for patients suffering from Alzheimer’s disease and related conditions.”

Cortexyme’s Clinical Advisory Board Members:

Mark Brody, M.D. is president and founder of Brain Matters Research, one of the largest private clinical research facilities in the United States specializing in AD diagnosis, treatment and research. He is a nationally recognized expert in both AD and stroke, as well as the principal investigator (PI) in numerous clinical trials seeking to prevent and treat Alzheimer’s disease. Martin R. Farlow,   M.D. is professor emeritus in the Department of Neurology and co-director of the Alzheimer’s Disease Center at Indiana University. Dr. Farlow’s research focuses on clinical trials of investigational drugs for the treatment of AD and related dementias, and he has been the lead investigator for several major studies for approved Alzheimer’s treatments including tacrine, donepezil and rivastigmine. Dr. Farlow has authored numerous peer-reviewed scientific publications and lectured on the topics of aging, dementia and AD at more than 300 meetings, conferences, and hospitals and medical schools throughout the world. Louis Kirby, M.D. is a board-certified neurologist and consultant in CNS drug development, medical devices, and laboratory-developed diagnostics. Having served as a PI on nearly 400 clinical trials, he currently consults with the pharmaceutical industry as a medical monitor, acting CMO, DSMB chair, and expert on strategic issues and protocol writing and review. Dr. Kirby founded and ran Pivotal Research Centers, which grew to become one of the largest private clinical research centers in the country; following its sale, he served as chief medical officer at Provista Life Sciences (diagnostics) and as a medical director at Neuraltus Pharmaceuticals. David Munoz, M.D. is a professor of neurology and neuropathology at the University of Toronto, and an expert on AD pathology. He is trained in neurology and neuropathology and is the author of 194 peer-reviewed papers and 20 book chapters, as well as the co-author of one book. His research interest is focused on neuropathology, particularly the mechanisms of development and progression of degenerative diseases of the brain, including AD. Mark Ryder, D.M.D., a bacterial infection and inflammation specialist , is a professor at the University of California, San Francisco (UCSF), where he has been a faculty member for 39 years. He has served as the PI, Co-PI, Co-Investigator, and/or examiner for many government- and industry-sponsored clinical studies related to infection and disease. Marwan Sabbagh, M.D., director of the Cleveland Clinic Lou Ruvo Center, is a board-certified neurologist and dementia expert. He has dedicated most of his career to finding a cure for Alzheimer’s and other age-related neurodegenerative diseases. He is a leading investigator for many prominent national Alzheimer’s prevention and treatment trials, including Alzheimer’s immunotherapy studies. He has authored and co-authored more than 300 medical and scientific articles on Alzheimer’s research. Eric Siemers, M.D. is the founder and president of Siemers Integration LLC, and consults for a variety of projects related to neurodegenerative diseases. Previously he served as a Distinguished Medical Fellow for Eli Lilly and Company’s Alzheimer’s Disease Global Development Team, where his responsibilities included the design and implementation of five large, Lilly-sponsored phase 3 clinical studies in AD. Dr. Siemers’ experience in both early and late phase clinical trials of neurodegenerative diseases spans over 25 years, with both academic and industry appointments. Dr. Siemers’ focus is on the use of biomarkers and the development of trial designs that fully characterize the effects of investigational drugs on chronic diseases. Stephen Thein, Ph.D., is the director and founder of Pacific Research Network, an ERG Portfolio Company. He is one of the nation’s leading researchers in memory and Alzheimer’s disease and has conducted over 250 clinical trials. Dr. Thein has participated in the testing of several new medications to treat Alzheimer’s disease, memory loss, anxiety, migraine, sleep disorders, sexual dysfunction, smoking, social anxiety, and weight loss.

About COR388

COR388 is a first-in-class, orally administered bacterial protease inhibitor that targets a specific pathogen discovered in the brains of patients with Alzheimer’s by Cortexyme’s co-founder and chief scientific officer, Stephen Dominy, M.D. Cortexyme designed COR388 to inhibit this pathogen in a way that broad spectrum antibiotics cannot, giving it the potential to rescue neurons from bacterial toxicity and prevent further cognitive decline and dysfunction. If borne out in clinical testing, COR388 could represent a wholly new approach to addressing a disease estimated to affect more than 5.4 million people in the United States. 1

About Cortexyme

Cortexyme is a privately held, clinical-stage pharmaceutical company developing therapeutics to alter the course of Alzheimer’s and other degenerative disorders. Cortexyme is targeting a specific, undisclosed infectious pathogen tied to neurodegeneration and chronic inflammation in humans and animal models. The company’s lead compound, COR388, is the subject of an ongoing phase 1b clinical development program; additional proprietary small molecules are moving forward in preclinical development. Cortexyme’s investors include Sequoia Capital, Vulcan Capital, Verily Life Sciences, EPIQ Capital Group, RSL Investments, Lamond Family, Pfizer, Takeda Ventures, Breakout Ventures, Dolby Family Ventures, and Breakout Labs among others. For more information on Cortexyme, visit www.cortexyme.com.

1https://www.cdc.gov/chronicdisease/resources/publications/aag/alzheimers.htm

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CONTACT: For Cortexyme

Hal Mackins, 415-994-0040

hal@torchcomllc.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL

SOURCE: Cortexyme, Inc.

Copyright Business Wire 2018.

PUB: 09/27/2018 08:00 AM/DISC: 09/27/2018 08:01 AM

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