Annovis Bio has commenced the treatment of first two subjects in a randomised Phase III clinical trial to assess the efficacy and safety of buntanetap in treating early Alzheimer's disease (AD).

The treatment period in the placebo-controlled, double-blind trial is said to span 18 months.

The trial will comprise two segments: a six-month evaluation focused on assessing symptomatic effects followed by a 12-month evaluation period to assess the therapy’s disease-modifying effects.

More than 750 subjects are expected to be enrolled across approximately 100 US sites.

Conquest Research in Winter Park, Florida, as well as Advanced Memory Research Institute of New Jersey in Tom’s River are the first two sites to begin recruitment.

The primary outcomes of the trial include assessing cognition using the Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) subscale and functional ability using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale.

The Phase III trial was launched after the company reported positive findings from a Phase II/III study.

In the Phase II/III trial, the treatment offered significant cognitive improvement in a subgroup of early AD patients without any safety concerns reported.

Annovis Bio CEO, founder, and president Maria Maccecchini said: "The launch of our highly anticipated AD study is a significant milestone in advancing buntanetap toward market approval and addressing the unmet medical need of millions of patients.

“Our previous trials have delivered compelling results, and we have meticulously designed a comprehensive protocol to evaluate both the symptomatic and potential disease-modifying effects of our drug candidate.”

Annovis secured $21m through a public offering to fund the initial six-month stage of the study, with the subsequent 12-month phase expected to be financed through additional funds from warrant exercises.

An oral small molecule, buntanetap is designed to target neurodegeneration by inhibiting the translation of neurotoxic, aggregating proteins, thus preventing the toxic cascade.

In August 2022, the company dosed the first subject in a Phase III trial of buntanetap for early PD.