Treatment with buntanetap (Annovis Bio, Malvern, PA), an oral molecule with potential therapeutic applications in neurodegenerative conditions such as Parkinson disease (PD) and Alzheimer disease (AD), was associated with improvements in motor and non-motor activities and cognitive functions in people with early PD, according to researchers. Additionally, buntanetap was found to be safe and well-tolerated in this study.

The findings were from a phase 3 prospective, double-bind, placebo-controlled clinical trial (NCT05357989) assessing the safety, tolerability, and efficacy of 10 mg or 20 mg buntanetap as a treatment for 450 individuals aged 40 to 85 years with a diagnosis of idiopathic PD. Only individuals with Mini-Mental State Exam (MMSE) scores between 20 and 30 were included. For a period of 6 months, participants were assigned to receive either placebo, buntanetap at 10 mg, or buntanetap at 20 mg as an oral capsule administered daily. The primary outcomes were change from baseline in Movement Disorder Society—Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II score, and safety and tolerability. Secondary endpoints included MDS-UPDRS Parts III, II+III, and Total scores.

In terms of cognitive function:

• All participants treated with placebo showed cognitive deterioration.
• All participants treated with buntanetap maintained baseline cognition levels, suggesting that treatment with buntanetap may stop cognitive decline.
• Participants with mild dementia (MMSE 2026) who were treated with buntanetap at 20 mg showed significant improvements in cognition.

In terms of motor and non-motor PD-related functions:

• Participants with a diagnosis of <3 years showed no deficits or minimal deficits in MDSUPDRS Part II, meaning that it was difficult to measure treatment efficacy in this population.
• Participants who had a diagnosis of >3 years who were treated with buntanetap showed significant improvements in MDSUPDRS Part II, as well as in MDS-UPDRS Parts III, II+III, and Total scores compared with those assigned to placebo and with baseline scores.
• Participants with postural instability and gait difficulty (PIGD) who were treated with buntanetap showed significant improvements in MDSUPDRS Parts II, III, II+III, and Total scores and were shown to respond better to treatment than other participants with PD.

Maria Maccecchini, PhD, Founder, President, and CEO of Annovis Bio stated, “These compelling data reinforce our commitment to advancing buntanetap into a longer study, which will allow us not only to verify observed symptomatic improvements but also to explore buntanetap’s disease-modifying properties.”