MALVERN, Pa. - Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company, announced today the results from its Phase II/III Alzheimer study of buntanetap, showing significant cognitive improvements in patients with mild Alzheimer's disease (AD). The company is now preparing for a Phase III trial focused on early AD patients with positive biomarkers.
In the study, patients with mild AD who were treated with buntanetap experienced a 3.3-point improvement in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) scores over three months, compared to a 0.3-point improvement in the placebo group. This outcome supports previous findings from Phase II trials. Additionally, a reduction in plasma Tau protein levels was observed, consistent with earlier biomarker data.
The Phase II/III trial was a randomized, double-blind, placebo-controlled study that enrolled 353 patients across 54 sites in the United States. It assessed the efficacy, safety, and tolerability of three doses of buntanetap (7.5mg, 15mg, or 30mg) over a 12-week period. The trial's co-primary endpoints were ADAS-Cog 11 and the Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change (ADCS-CGIC).
While the ADCS-CGIC endpoint did not show a statistically significant difference, the study found a dose-dependent relationship between the treatment and baseline Mini Mental State Examination (MMSE) scores in patients positive for AD biomarkers. The higher the dose, the more pronounced the response in patients with milder AD.
The treatment was well tolerated, with a safety profile in line with previous studies. No serious adverse events related to buntanetap were reported. The majority of adverse events were mild to moderate in severity.
Annovis Bio plans to present the study data at the Alzheimer's Association International Conference (AAIC) 2024 and publish it in a peer-reviewed journal. The company aims to discuss the data with the FDA and proceed to a disease-modifying Phase III trial.
This announcement is based on a press release statement.
InvestingPro Insights
Annovis Bio, Inc. (NYSE: ANVS) has recently shared promising results from its Phase II/III Alzheimer study, which may have caught the attention of investors and analysts alike. With the clinical-stage company preparing for a pivotal Phase III trial, here are some key insights from InvestingPro that could provide additional context to the company's financial health and stock performance:
InvestingPro Data:
- Market Cap (Adjusted): 162.86M USD
- P/E Ratio (Adjusted) last twelve months as of Q4 2023: -3.3
- 1 Month Price Total Return as of the 120th day of 2024: 51.34 %
InvestingPro Tips:
1. Annovis Bio's net income is expected to grow this year, which may reflect optimism about the company's future profitability following the recent clinical trial results.
2. The stock has experienced significant returns over the last month, with a 51.34% increase, which could indicate strong investor confidence in the wake of the study's positive outcome.
Investors and market watchers may find these metrics particularly relevant as they assess the potential of Annovis Bio's drug platform and its implications for Alzheimer's treatment. The company's stock price movements are quite volatile, which is typical for clinical-stage biotech firms, especially those on the verge of transitioning to late-stage trials. The expected growth in net income and the recent price uptick could signal a positive shift in the company's trajectory.
While the RSI suggests the stock is in overbought territory, the strong return over the last month underscores the market's reaction to the company's promising trial results. For those interested in a deeper dive into the company's performance and future prospects, there are 11 additional InvestingPro Tips available at https://www.investing.com/pro/ANVS. Don't forget to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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