Annovis Bio has initiated its pivotal Phase 3 trial for buntanetap, an oral drug candidate for early-stage Alzheimer’s disease. The trial will assess both the symptomatic and disease-modifying potential of the drug over 18 months in over 750 participants. This follows promising results from a Phase 2/3 study showing cognitive improvement in early AD patients without safety concerns.
This Phase 3 trial represents a crucial step towards a potential treatment option for Alzheimer’s, a devastating disease with significant unmet medical needs. The dual focus on both symptom management and disease modification is particularly important, offering the possibility of not only improving patients’ quality of life but also slowing or halting disease progression. Positive results could significantly reshape the Alzheimer’s treatment landscape.
The 18-month trial is structured in two parts: a 6-month symptomatic assessment and a subsequent 12-month evaluation of disease-modifying effects. Annovis recently secured $21 million through a public offering to fund the initial 6-month phase, with anticipated warrant exercises covering the remaining 12 months. The primary outcomes will measure cognitive changes using the ADAS-Cog13 subscale and functional abilities using the ADCS-iADL scale. Recruitment has begun at two sites in Florida and New Jersey.
The commencement of this Phase 3 trial signifies a critical juncture for Annovis and the potential future of Alzheimer’s treatment. Successful trial results could lead to market approval for buntanetap, providing a much-needed new therapy and potentially validating Annovis’s neurodegenerative disease platform. The coming months will be crucial as data emerges from this pivotal study.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
