The U.S. Federal Drug Administration (FDA) has accepted an updated protocol for Malvern-based Annovis Bio’s Phase 3 Alzheimer’s disease (AD) study that begins this month.
The FDA granted Annovis clearance to proceed in October with the study based on data demonstrating cognitive improvement in early-stage AD patients. Under the original protocol, the company proposed two separate trials. One would last six months and be a symptomatic study while the other would last 18 months and be a disease-modifying study.
The revised protocol integrated the studies into a single 6/18-month trial that includes a six-month data readout focused on symptomatic effects followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap, Annovis’ oral therapy candidate.
“This consolidated protocol will accelerate the development timeline while maintaining the scientific rigor necessary to advance buntanetap as a treatment for AD,” Dr. Maria Maccecchini, Annovis founder, president and CEO, said. “With this design, we can leverage the 6-month symptomatic data to potentially support a new drug application filing, all while continuing the same study seamlessly to assess long-term disease-modifying outcomes. We are excited to move forward with this approach, which brings us closer to delivering a novel treatment to patients in need.”