Annovis Bio's Buntanetap Safe, Effective for High-Risk Alzheimer's Patients
June 11, 2024 – Annovis Bio Inc. (NYSE: ANVS), a company at the forefront of developing treatments for neurodegenerative diseases, has revealed promising outcomes from its latest Phase II/III clinical trial. The trial involved Buntanetap, their leading drug candidate, aimed at treating Alzheimer’s disease (AD) and Parkinson’s disease (PD). Remarkably, Buntanetap displayed significant efficacy and safety across both carriers and non-carriers of the Apolipoprotein E4 (APOE4) gene, known to be a genetic marker for AD.
The study’s findings will be elaborated upon in an investor call scheduled for today at 4:30 PM ET, where interested parties are urged to join for a comprehensive discussion.
Primary Results
Buntanetap demonstrated a considerable dose-response effect in patients with early Alzheimer’s (MMSE 21-24), showing a -3.3 point improvement from baseline and a -2.3 point improvement compared to placebo on the ADAS-Cog11 cognitive assessment scale. Specifically, APOE4 carriers treated with a 15mg dose of Buntanetap showed a -3.15 improvement in their ADAS-Cog11 scores.
Safety Profile
Safety was comparable between APOE4 carriers and non-carriers, with no occurrences of Amyloid-Related Imaging Abnormalities (ARIA). The detailed study included 159 APOE4 carriers (33 homozygotes and 126 heterozygotes) and an equal number of non-carriers, showcasing a balanced participant pool.
Contextual Importance
Recent studies published in Nature Medicine have identified APOE4 homozygosity as a distinct genetic subtype of Alzheimer’s, necessitating personalized prevention strategies and treatments. Dr. Samuel Gandy, an Alzheimer’s researcher at Mount Sinai, cited the elevated safety risks linked to anti-amyloid drugs for APOE4 homozygotes, including serious side effects like brain swelling and bleeding. The FDA had earlier mandated a black-box warning for the anti-amyloid drug Leqembi due to these risks. However, Buntanetap did not show increased safety concerns for APOE4 carriers, marking a significant achievement in the field.
Forward Strategy
Buoyed by the positive results of this trial, Annovis Bio plans to initiate an 18-month Phase III trial targeting biomarker-positive early AD patients. This forthcoming study aims to further establish the efficacy and safety profile of Buntanetap and will be conducted under FDA guidelines.
Buntanetap Overview
Buntanetap (formerly known as Posiphen or ANVS401) is designed to combat neurodegeneration by inhibiting the formation of multiple harmful proteins, including amyloid beta, tau, alpha-synuclein, and TDP43. Its mechanisms are aimed at improving synaptic transmission, enhancing axonal transport, and reducing neuroinflammation, thereby reversing neurodegenerative processes in diseases like AD and PD.
About Annovis Bio Inc.
Based in Malvern, Pennsylvania, Annovis Bio Inc. is dedicated to addressing the challenges of neurodegenerative diseases such as Alzheimer’s and Parkinson’s. The company focuses on innovative approaches to treatment that target multiple neurotoxic proteins, aiming to restore brain function and enhance patient quality of life.
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