The US Food and Drug Administration (FDA) has accepted an updated protocol for Annovis Bio’s late-stage Alzheimer’s disease (AD) study, which is scheduled to begin this month.
The announcement comes three months after the regulator gave Annovis clearance to proceed with a phase 3 AD programme consisting of a six-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month trial designed to demonstrate the candidate’s disease-modifying potential.
The studies will now be combined into a single six/18-month trial, which will include a six-month data readout focused on symptomatic effects, followed by an additional 12-month disease-modifying assessment.
Annovis’ founder, president and chief executive officer, Maria Maccecchini, said the consolidated protocol will “accelerate the development timeline while maintaining the scientific rigour necessary to advance buntanetap as a treatment for AD”.
Maccecchini added that the six-month symptomatic data from the study could be used to support a new drug application filing while the study continues to assess long-term disease-modifying outcomes.
AD is the most common form of dementia, affecting approximately seven million people in the US. The neurodegenerative disease slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Buntanetap is an oral molecule that attacks neurodegeneration by inhibiting the formation of multiple neurotoxic proteins. According to Annovis, this gives the candidate the ability to reverse neurodegeneration in AD, Parkinson’s disease and other neurodegenerative disorders.
The company announced positive results from a phase 2/3 AD trial of buntanetap in April. The study demonstrated a significantly higher rate of improvement in AD Assessment Scale-Cognitive Subscale 11, a performance-based assessment of cognitive function, scores at all three buntanetap dose levels compared to placebo in patients with biomarker-positive early AD.
Melissa Gaines, senior vice president of clinical operations, and Cheng Fang, senior vice president of research and development at Annovis, said at the time: “Based on buntanetap’s unique mechanism of action, we believe it can give patients both symptomatic and disease-modifying benefits.
“It’s really exciting to see that this study confirmed what we have observed in the previous phase 2 studies in both the improvement of patients’ cognition and the improvement of biomarkers.”