Annovis Bio’s Buntanetap Found Safe and Effective in High-Risk Alzheimer's Patients
Annovis Bio announced positive results from its Phase II/III Alzheimer's study of Buntanetap, showing effective and safe outcomes in high-risk Alzheimer's patients, including APOE4 carriers.
The study revealed a significant dose-response in early AD patients with improvements in ADAS-Cog11 scores, showing a -3.3 points improvement over baseline and -2.3 points over placebo.
APOE4 carriers treated with 15mg Buntanetap showed a -3.15 improvement in ADAS-Cog11 scores. The drug was also deemed safe, with no reported instances of ARIA.
The trial included 318 participants, with equal numbers of APOE4 carriers and non-carriers.
Annovis is planning an 18-month Phase III trial focusing on biomarker-positive early AD patients, further validating the drug's efficacy and safety.
An investor call discussing these findings is scheduled for June 11, 2024, at 4:30 PM ET.
- Buntanetap showed statistically significant efficacy in early AD patients with a -3.3 points improvement over baseline.
- APOE4 carriers treated with 15mg Buntanetap had a -3.15 improvement in ADAS-Cog11 scores.
- Buntanetap demonstrated comparable safety in both APOE4 carriers and non-carriers, with no ARIA instances.
- The study included an equal number of APOE4 carriers and non-carriers, totaling 318 participants.
- Annovis Bio plans an 18-month Phase III trial focusing on biomarker-positive early AD patients.
- The announcement did not include specific financial data or revenue projections.
- No immediate plans for commercial release were mentioned, focusing instead on future trials.
- Potential risks of the long-term efficacy and safety of Buntanetap remain unaddressed until the Phase III trial results are available.
Insights
Buntanetap's recent Phase II/III trial results present a significant development in the fight against Alzheimer's, particularly for patients at high genetic risk. The study's finding of a statistically significant improvement in ADAS-Cog11 scores, particularly among APOE4 carriers, is highly promising. APOE4 is a well-known genetic marker that significantly increases Alzheimer's risk and the ability to demonstrate efficacy in this group is an encouraging sign for a broader application of Buntanetap.
Moreover, the lack of serious side effects, such as Amyloid-Related Imaging Abnormalities (ARIA), differentiates Buntanetap from other treatments like Leqembi. This could make it a more attractive option for both patients and healthcare providers, especially given the serious safety concerns associated with other anti-amyloid treatments.
Moving into a Phase III trial will be important to confirm these results over a longer period and with a broader patient population. If these results hold, Buntanetap could become a cornerstone treatment for Alzheimer's, especially for genetically predisposed individuals.
The positive Phase II/III trial results for Buntanetap could have a significant impact on Annovis Bio's stock performance. Demonstrating both safety and efficacy in Alzheimer's patients, particularly in those with the APOE4 genetic marker, positions Buntanetap as a potentially groundbreaking therapy. Given the size of the Alzheimer's market, successful commercialization could drive substantial revenue growth for Annovis Bio.
Investors should note the upcoming Phase III trial, which will be important for securing FDA approval and subsequent market entry. The trial's outcomes will likely be a major catalyst for the stock, with positive results potentially leading to a substantial increase in valuation. Additionally, the lack of severe side effects positions Buntanetap favorably against current market competitors, potentially increasing its adoption rate upon approval.
However, it's important to remain cautious. The biotech sector is speculative and future trial outcomes are uncertain. Investors should weigh these risks against the potential high rewards that successful drug approval could bring.
Buntanetap's trial results suggest a major advancement in Alzheimer's treatment, particularly given the drug's efficacy in both APOE4 carriers and non-carriers. The Alzheimer's market is substantial and growing, driven by an aging global population and the current lack of highly effective treatments. If Buntanetap continues to show efficacy and safety in future trials, it could capture a significant share of this market.
The safety profile of Buntanetap, especially its lack of ARIA, is a key differentiator. Competing treatments like Leqembi have faced significant safety issues, which could limit their widespread adoption. By contrast, Buntanetap's favorable safety data could make it the preferred choice among healthcare providers and patients, particularly those with the APOE4 genotype.
Looking ahead, the planned Phase III trial will be critical in determining Buntanetap's long-term viability. Success in this trial could lead to FDA approval and rapid market adoption, creating substantial growth opportunities for Annovis Bio. However, the competitive landscape remains intense and regulatory hurdles are high. Investors should monitor the trial's progress closely.
Join Our Investor Call for In-Depth Findings Discussion
MALVERN, Pa., June 11, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage drug platform company developing novel therapies for neurodegenerative diseases such as Alzheimer’s (AD) and Parkinson’s disease (PD), today announces that its recent Phase II/III Alzheimer’s study of its lead drug candidate, Buntanetap, showed statistically significant efficacy and safety in both carriers and non-carriers of Apolipoprotein E4 (APOE4), a genetic cause of AD.
Interested parties are encouraged to register for the upcoming investor call today at 4:30 PM ET, where detailed findings will be discussed. https://zoom.us/webinar/register/3117176913600/WN_Ev_1s7l2RUKmIQJNdko5iA
Key Findings:
- Efficacy in Early AD Patients: In patients with early AD (MMSE 21-24), Buntanetap showed a statistically significant dose-response in ADAS-Cog11 scores, with a -3.3 points improvement over baseline and -2.3 points improvement from placebo.
- APOE4 Carriers: In APOE4 carriers treated with 15mg Buntanetap, there was a -3.15 improvement in ADAS-Cog11 scores.
- Comparable Safety: Buntanetap was found to be equally safe in both APOE4 carriers and non-carriers, with no instances of ARIA (Amyloid-Related Imaging Abnormalities).
- Patient Breakdown: The study included 159 APOE4 carriers (33 homozygotes and 126 heterozygotes) and 159 APOE4 non-carriers.
Scientific Context: Recent findings published in Nature Medicine have redefined APOE4 homozygosity as a distinct genetic form of Alzheimer’s disease, requiring individualized prevention strategies, clinical trials, and treatments. This study emphasized the near-full penetrance of AD biology in APOE4 homozygotes, suggesting that these patients represent a significant target group for therapeutic interventions.
Safety Insights: Dr. Samuel Gandy, an Alzheimer’s researcher at Mount Sinai, highlighted the heightened safety risks for APOE4 homozygotes from anti-amyloid drugs, such as Leqembi, which have been associated with serious side effects like brain swelling and bleeding. When the Food and Drug Administration approved the anti-amyloid drug Leqembi last year, it required a black-box warning — the agency’s strongest caution — because of safety concerns for people with two copies of APOE4. However, Buntanetap demonstrated no increased safety issues compared to placebo, even in APOE4 carriers.
During our upcoming investor call, we will discuss the recent New York Times article that underscores the serious implications for APOE4 carriers.
Future Plans: Encouraged by these results, Annovis Bio is planning an 18-month Phase III trial focusing on biomarker-positive early AD patients. This trial aims to further validate Buntanetap’s efficacy and safety profile and will be conducted under the guidance of the FDA.
Investor Call: Annovis Bio will host an investor call to discuss these findings in detail and outline the future development plans for Buntanetap.
- Date and Time: June 11, 2024, 4:30 pm ET.
- Register Now: https://zoom.us/webinar/register/3117176913600/WN_Ev_1s7l2RUKmIQJNdko5iA
About Buntanetap: Buntanetap (formerly known as Posiphen or ANVS401) targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43. By improving synaptic transmission, axonal transport, and reducing neuroinflammation, Buntanetap aims to reverse neurodegeneration in AD, PD, and other neurodegenerative diseases.
About Annovis Bio Inc.: Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn and X.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Contacts
Annovis Bio, Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
IR@annovisbio.com
Investor Website
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FAQ
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