Michael Detke (United States of America)
Cortexyme
Chief Medical Officer
Dr. Detke is clinical drug development scientist/executive with over 20 years of research and leadership in biotech/pharma. He has experience with clinical trials across many CNS diseases and all phases of development, including many INDs and NDAs. He is Chief Medical Officer at Cortexyme, a clinical-phase biotech developing therapeutics for a specific pathogen, for the treatment of Alzheimer's and other degenerative disorders. Previously, as CMO at Embera NeuroTherapeutics, led clinical development of a novel combination drug for addictions. As CoMentis CMO, led clinical development of alpha7 ligands for Alzheimer's Disease and other disorders of cognition. As MedAvante CMO, led a team improving signal detection in CNS clinical trials. As Executive Director for Neuroscience at Lilly, responsible for all CNS assets in early phase development (Psychiatry, Neurology, Pain and Addiction). Previously at Lilly, Senior Medical Director responsible for global Phase 3 development for Cymbalta ($5B peak sales) and Phase 4 for Prozac. Undergraduate at Yale, MD/PhD at U. Penn. and Psychiatry Residency at Harvard/MGH/McLean. Over 70 manuscripts published in peer-reviewed journals, and an active member of scientific organizations such as ACNP, ASCP and SOBP. Board-certified Psychiatrist and adjunct Clinical Professor of Psychiatry at Indiana University School of Medicine since 2000.

Presenter of 1 Presentation

 Conference Calendar

ADDITIONAL DATA FROM THE PHASE 2/3 GAIN TRIAL OF COR388 (ATUZAGINSTAT) FOR THE TREATMENT OF MILD-MODERATE ALZHEIMER’S DISEASE

Session Name
1940 - ABETA AND OTHER TARGETING THERAPIES IN AD (ID 95)
Session Type
SYMPOSIUM
Date
Sun, 20.03.2022
Session Time
09:05 AM - 11:05 AM
Room
ONSITE: 113
Lecture Time
10:20 AM - 10:35 AM
Presenter

Abstract

Aims

Additional analysis of data from the GAIN trial, a large Phase 2/3 randomized, double-blind, placebo-controlled clinical trial in mild-moderate AD testing the efficacy and safety of the oral small-molecule atuzaginstat, a novel P. gingivalis virulence factor inhibitor.

Methods

The Phase 2/3 GAIN trial (NCT03823404) completed enrollment in November 2020. 643 subjects (aged 55-80; mild-moderate AD with MMSE 12-24) were randomized 1:1:1 to one of two doses of atuzaginstat (40mg or 80mg BID) or placebo for 48 weeks.

Results

Baseline data show that the 643 randomized subjects are typical of a mild-moderate AD population: 57% female, 64% ApoE4 carriers, 50% mild (MMSE = 19-24) and 50% moderate (MMSE 12-18). 70% were from the United States and 30% from Europe. 74% of subjects received symptomatic AD co-medications. Topline data indicated efficacy of both doses of atuzaginstat in prespecified P. gingivalis infected populations. Changes in P. gingivalis DNA in saliva correlated significantly with outcomes on multiples scales, including ADAS-Cog, CDR-SB, and MMSE. New analyses will be shared.

Conclusions

Enrollment of the GAIN trial was completed in November 2020, and topline data announced in October 2021. The GAIN trial provided further support that P. gingivalis is a novel driver of disease in an easily identified population comprising approximately 50% of the mild to moderate patients. Atuzaginstat slowed cognitive decline in Alzheimer’s disease with P. gingivalis by approximately 50% on ADAS-cog. Additional analyses are pending and will be shared.

Hide