Annovis Bio, Inc. (NYSE: ANVS) has announced that it has received FDA clearance to proceed with Phase 3 clinical trials for its lead drug candidate, buntanetap, in patients with early Alzheimer's disease (AD). The pivotal trials will include a 6-month study focused on symptomatic effects, scheduled to begin in Q1 2025, and an 18-month study assessing disease-modifying potential. This announcement follows a successful End-of-Phase 2 meeting with the FDA, marking a significant step forward in the development of a new treatment for this debilitating neurodegenerative disease.
The FDA's decision was based on a review of Annovis Bio's Phase 2/3 study data, with no concerns raised regarding the safety profile of buntanetap, including liver enzyme levels, potential drug interactions, dose selection, pharmacokinetics, and population pharmacokinetics. The trials will utilize a new crystal form of buntanetap, streamlining the development process.
Financial Position
Alongside the clinical update, Annovis Bio reported its financial results for the third quarter of 2024. As of November 8, 2024, the company held $13.6 million in cash and cash equivalents, deemed sufficient to cover preparatory studies and the initiation of the Phase 3 AD trial. The company reported a net loss of $0.97 per share for the quarter, an improvement compared to the $1.63 loss per share in Q3 2023. Operating expenses for the quarter totaled $4.4 million, including $2.7 million in research and development and $1.7 million in general and administrative costs. This represents a significant decrease from the $14.9 million in operating expenses reported for the same period in 2023.
Intellectual Property and Combination Therapies
Annovis Bio has also strengthened its intellectual property portfolio with the filing of three new patents covering innovative combination therapies involving buntanetap. These patents include combinations of buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, representing a multifaceted approach to treating neurodegenerative diseases and improving cognition.
Management Commentary
"The third quarter was marked by important milestones outlining the next steps for buntanetap," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "The FDA gave us the green light to initiate confirmatory Phase 3 studies for early AD, and our team has been working hard to begin them in the coming year. We also strengthened our intellectual property portfolio by filing unique patents protecting new combinations of buntanetap with other medications for improving cognition."
About Buntanetap
Buntanetap is an oral translational inhibitor of multiple neurotoxic proteins (TIMPs). The drug selectively inhibits the synthesis of amyloid-beta (Aβ), tau, α-synuclein, and TDP-43. By lowering the levels of these proteins, Buntanetap has the potential to improve synaptic transmission, reduce inflammation, and restore axonal transport, ultimately slowing down or reversing the progression of neurodegenerative diseases.
