Benzinga | Jul 20, 2021 08:41AM EDT

Annovis Bio Reports Safety Data From Its Phase 2 Alzheimer's Study; Says Data Safety Monitoring Board Has Reviewed Safety And Tolerability Data For Cohort 2 Of Trial And Has Approved Study To Proceed With Cohort 3

Safety and tolerability data for Cohort 2 of the Discover Study reviewed by Data Safety Monitoring Board, allowing the study to proceed with the final cohort

Berwyn, Pennsylvania--(Newsfile Corp. - July 20, 2021) - Annovis Bio, Inc. (NYSE:ANVS), ("Annovis" or the "Company"), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, with data from two phase 2 studies showing its lead compound improves cognition in AD patients and motor function in PD patients, today announced that the Data Safety Monitoring Board (DSMB) has reviewed the safety and tolerability data for Cohort 2 of the Company's Phase 2 AD trial and has approved the study to proceed with Cohort 3, the final cohort of the study. Funding for this clinical research was provided by a grant from the National Institutes on Aging and the study is run by the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego School of Medicine.

Previously, Annovis Bio announced the DSMB approval to continue from Cohort 1 of the study, after it reviewed data from the first eight patients in the Phase 2 AD trial treated with ANVS401, the Company's lead compound, at a dosage of 60 milligrams (mg) per day. The safety evaluation of Cohort 2, conducted by the DSMB, reviewed data from an additional eight patients treated with ANVS401 at a dosage of 120 mg per day (2x60 mg) or placebo.

Douglas Galasko, Professor, Department of Neurosciences at UC San Diego School of Medicine and Martin Farlow, MD, Professor and Vice Chairman of Research, Indiana University School of Medicine, are serving as Project Directors for the study.

"We are extremely pleased to have the DSMB's approval to move to our third and final cohort of our DISCOVER Phase 1/2 AD trial," stated Howard Feldman, MD, Director of the ADCS and Professor of Neurosciences at UC San Diego School of Medicine. "With Cohort 3 now open, without modification, our trial sites are now able to screen patients and are expected to reach full enrollment for this trial. We are encouraged by this trial's progress in evaluating multiple doses and effects on amyloid beta peptide production and clearance and are hopeful, looking forward to the final trial results."

The Phase 2 AD trial, taking place at six sites, including UC San Diego, Johns Hopkins, Indiana University, Washington University, the Cleveland Clinic, and Columbia University, is a 24-patient study. Final data readout from the study is expected next year.