Annovis Bio ANVS is a clinical-stage drug platform company addressing neurodegenerative diseases, such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD).

The company’s lead product candidate is buntanetap (formerly ANVS402 or posiphen), an investigational, oral translational inhibitor of neurotoxic aggregating proteins. This mode of action is expected to lead to a lower level of neurotoxic proteins and, consequently, less toxicity in the brain.

Currently, buntanetap is being evaluated in a late-stage study in early PD patients. The drug is also being evaluated in a phase II/III study in mild-to-moderate AD patients.

Since last month, shares of Annovis Bio have soared 37.8% compared to the industry’s 0.2% rise.

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This upside came after management reported that it exceeded complete enrolment in the phase II/III study evaluating the efficacy, safety, and tolerability of buntanetap in AD indication over a 12-week treatment period. This study, designed by Annovis to enroll 320 patients, has screened more than 700 patients and enrolled a total of 353 patients.

The study is designed to assess cognition and activities of daily living in AD patients receiving either three doses of buntanetap (7.5mg, 15mg or 30mg) or a placebo on top of their standard of care for 12 weeks. This will be measured by changesfrom baseline to the end of treatment in AD Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) and AD Cooperative Study Clinician’s Global Impression of Change (ADCS-CGIC), the co-primary endpoints of the study.

Annovis expects to report data from this study by the end of March 2024.

Per management, unlike other AD drugs — which target only one neurotoxin protein and only have a minor effect — buntanetap is designed to reduce levels of multiple neurotoxic proteins, namely amyloid beta, tau, alpha-synuclein and TDP43. By attacking multiple neurotoxic proteins, the Annovis Bio drug is likely to demonstrate the ability to reverse the destructive effects that a neurodegenerative disease like AD has on thinking and memory.

Apart from AD, management also intends to report data from the phase III study in PD patients by next month. Annovis intends to submit regulatory filings to the FDA for buntanetap in AD and PD indications by 2026-end.

The AD target market is highly competitive as several other pharma companies like Biogen BIIB and Eli Lilly LLY have their drugs targeting the AD indication. The AD drugs of these companies have either recently been approved for use or are under regulatory review development.