Annovis Begins Phase 3 Study of Buntanetap for Early Alzheimer's Disease

On February 5, 2025, Annovis Bio Inc., a company specializing in advanced clinical drug development for neurodegenerative diseases like Alzheimer’s and Parkinson’s, announced a pivotal step in its research. The company has initiated a Phase 3 clinical trial to study the effects of buntanetap in early-stage Alzheimer’s Disease (AD). This marks a major advancement towards seeking approval for buntanetap, a drug that aims to address a significant unmet need for millions of AD patients.

Maria Maccecchini, Ph.D., who is the Founder, President, and CEO of Annovis, expressed optimism about this milestone. She emphasized that previous studies on buntanetap have provided promising results. The new Phase 3 trial has been meticulously planned to thoroughly assess the drug's effects on both the symptoms and potential progression of the disease.

The design of the Phase 3 trial is both randomized and placebo-controlled, maintaining a double-blind format to ensure robust and unbiased results. The participants will receive a daily dose of buntanetap over an 18-month period. The initial six months will focus on observing changes in symptoms, followed by a year-long investigation into the drug’s potential to alter the progression of the disease. This trial protocol was approved by the FDA, thanks to encouraging findings from a previous Phase 2/3 study which highlighted cognitive improvements without raising safety concerns.

To finance the initial phase of this comprehensive study, Annovis recently concluded a public offering, successfully raising $21 million. This capital will cover the first six months of the study, and further funding is anticipated from the exercise of additional financing options for the subsequent 12-month phase.

Melissa Gaines, Senior Vice President of Clinical Operations at Annovis, highlighted the transformative potential of buntanetap for those affected by Alzheimer’s. She expressed gratitude to the community and all who have supported the initiative, emphasizing the company's commitment to enhancing the quality of life for patients and their families. Gaines is hopeful that the outcomes of this trial will contribute significantly to redefining Alzheimer’s treatment.

The primary objectives of the trial include evaluating cognitive functions with the Alzheimer’s Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) and assessing patients' functional abilities using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale.

The study plans to recruit over 750 participants at approximately 100 locations across the United States. Initial recruitment has commenced at Conquest Research in Winter Park, Florida, and the Advanced Memory Research Institute of New Jersey, located in Tom’s River. These sites are managed by Dr. Malisa Agard and Dr. Arun Singh, respectively.

Buntanetap, an orally administered compound, works by targeting the root causes of neurodegeneration. It inhibits the production of neurotoxic proteins, thus preventing the harmful cascade of events that lead to neuronal damage. By enhancing axonal transport and synaptic communication while reducing inflammation, buntanetap aims to restore neuronal health and improve brain function.

Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. remains committed to advancing treatments for neurodegenerative diseases like Alzheimer’s and Parkinson’s. The company continues to pioneer innovative therapies that hold the promise of better health outcomes for patients worldwide.