Annovis secures US patent for buntanetap

Annovis Bio Inc. has secured a U.S. patent for methods of treating acute traumatic brain injuries with its lead drug candidate, an oral, small molecule neurotoxic protein inhibitor.

According to a press release from Annovis, buntanetap (previously known as Posiphen or ANVS401) targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43, which are telltale biomarkers of Alzheimer’s disease pathology.

With the ability to target these pathways, buntanetap may reverse neurodegeneration in AD and Parkinson’s disease as well as other neurodegenerative conditions.

“We are thrilled to achieve this significant milestone for buntanetap,” Annovis founder, President and CEO Maria Maccecchini, PhD, told Healio in an email. “Nerve cell death is a common underlying factor in many brain conditions, beyond just Alzheimer’s and Parkinson’s. It is our duty to explore its potential benefits for victims of brain trauma, a prevalent issue in the United States.”

Annovis said that it initially filed a wide-ranging patent in 2016 for buntanetap to address conditions such as TBI, stroke and spinal cord injuries, which involve nerve injury or damage. The U.S. Patent and Trademark Office, however, required Annovis’ petitions to be split into individual patents for each potential application. The patent that was granted allows for buntanetap to be applied to TBI and nerve cell death prevention.

Buntanetap’s safety, efficacy and tolerability were investigated in a randomized, double-blind, placebo-controlled phase 2/3 clinical trial that was conducted in the U.S. and included 353 individuals with mild to moderate AD. Participants received 7.5 mg, 15 mg, or 30 mg of buntanetap, or placebo as an adjunct to standard care for 12 weeks.

The study, initiated in March 2023, came under review from the Data and Safety Monitoring Board months later, but was allowed to continue as planned.

Data showed cognitive gains and reduction of tau compared with placebo at the end of the treatment course.

“Going forward we will proceed with two full patent portfolios, one for use with the old buntanetap and one for composition of matter for the new (crystal form of) buntanetap,” Maccecchini added.