Full Press Release Details
Annovis Bio's Buntanetap Found Safe and
Effective in High-Risk Alzheimer's Patients
Join Our Investor Call for In-Depth Findings
Pa., June,11 2024 (GLOBE NEWSWIRE) -- 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.
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
| Placebo | 7.5mg Buntanetap | 15mg Buntanetap | 30mg Buntanetap | All Doses | ||||||
| APOE Carriers (N=159) | 38 | 45 | 38 | 38 | 121 | |||||
| # TEAEs | 13(34.2%) | 22(48.9%) | 17(44.7%) | 12(31.6%) | 51(42%) | |||||
| # TEAEs Related to Study Drug | 1(2.6%) | 8(17.8%) | 6(15.8%) | 3(7.9%) | 17(14%) | |||||
| # Serious TEAEs | 3(7.9%) | 0 | 0 | 1(2.6%) | 1(2.5%) | |||||
| # Serious TEAEs Related to Study Drug | 0 | 0 | 0 | 0 | 0 | |||||
| APOE Non-Carriers (N=159) | 41 | 34 | 43 | 41 | 118 | |||||
| # TEAEs | 9(22.0%) | 4(11.8%) | 11(25.6%) | 17(41.5%) | 32(27.1%) | |||||
| # TEAEs Related to Study Drug | 1(2.9%) | 1(2.9%) | 2(4.7%) | 3(7.3%) | 6(5.1%) | |||||
| # Serious TEAEs | 0 | 0 | 0 | 2(4.9%) | 2(1.7%) | |||||
| # Serious TEAEs Related to Study Drug | 0 | 0 | 0 | 0 | 0 |
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.
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.
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
Call: Annovis Bio will host an investor call to discuss these findings in detail and outline the future development plans for
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.
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
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.
101 Lindenwood Drive
InvestorBrandNetwork (IBN)