Annovis Bio Inc. (NYSE: ANVS) Announces Results From Phase II/III Buntanetap Study for the Treatment of Alzheimer’s Disease

  • Buntanetap is designed to target neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43
  • The study demonstrated significant efficacy and safety for buntanetap in a subgroup of early Alzheimer’s patients in both carriers and non-carriers of Apolipoprotein E4 (APOE4), a recognized genetic factor linked to Alzheimer’s
  • Annovis Bio has been selected to present detailed data from its Alzheimer’s study at the Alzheimer’s Association International Conference(R) 2024

June is Alzheimer’s & Brain Awareness Month, a time dedicated to raising awareness about Alzheimer’s disease and other forms of dementia, as well as the importance of brain health. Even though the month is almost over, Annovis Bio’s commitment to the Alzheimer’s community goes on.

Annovis Bio (NYSE: ANVS), a late-stage drug platform company, recently announced promising results from its Phase II/III study on buntanetap, a drug candidate aimed at treating neurodegenerative diseases like Alzheimer’s (“AD”) and Parkinson’s diseases (“PD”). The study demonstrated significant efficacy and safety in a subgroup of early Alzheimer’s patients for buntanetap in both carriers and non-carriers of Apolipoprotein E4 (APOE4), a recognized risk factor for AD (https://ibn.fm/mn4tM).

The study’s findings are highly encouraging, showing substantial improvements in patients with early-stage Alzheimer’s:

  • Efficacy in Early AD Patients: Among patients with early AD (MMSE 21-24), buntanetap showed a statistically significant dose-response in ADAS-Cog11 scores. Patients exhibited a 3.3 points improvement over baseline and 2.3 points improvement compared to placebo.
  • APOE4 Carriers: APOE4 carriers also experienced a statistically significant 3.15 improvement in ADAS-Cog11 scores.
  • Comparable Safety: The safety profile of buntanetap was consistent across both APOE4 carriers and non-carriers, with no reported instances of Amyloid-Related Imaging Abnormalities (“ARIA”) and no severe adverse events.
  • Patient Demographics: The study included a balanced cohort of 318 participants, equally divided between 159 APOE4 carriers (33 homozygotes and 126 heterozygotes) and 159 non-carriers.

These findings are significant, especially in the context of recent research published in Nature Medicine. This research redefined APOE4 homozygosity as a unique genetic form of Alzheimer’s, necessitating specialized prevention strategies, clinical trials, and treatments. It emphasized the near-complete penetrance of AD biology in APOE4 homozygotes, identifying them as a crucial target group for therapeutic interventions.

Dr. Samuel Gandy, an Alzheimer’s researcher at Mount Sinai, highlighted the heightened safety risks associated with anti-amyloid drugs like Leqembi for APOE4 homozygotes, noting severe side effects such as brain swelling and bleeding. Buntanetap demonstrated no increased safety issues compared to placebo, even among APOE4 carriers (https://ibn.fm/6mvro).

Buntanetap, formerly known as Posiphen or ANVS401, is designed to target 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. This multi-targeted approach positions buntanetap as a potential breakthrough in treating these debilitating conditions.

In recognition of these significant findings, Annovis Bio has been selected to present detailed data from its Alzheimer’s study at the Alzheimer’s Association International Conference(R) 2024 (“AAIC”). This prestigious conference will take place from July 28 to August 1 in Philadelphia, USA, and online (https://ibn.fm/0p9Nz). Dr. Cheng Fang, Senior VP of Research & Development at Annovis Bio, Kathleen A. Welsh-Bohmer, Ph.D., Professor in Psychiatry and Neurology at Duke University, and Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio Inc., will deliver a comprehensive 45-minute presentation during the conference.

“We look forward to sharing the details of our Phase II/III results with the scientific community at this prominent conference,” said Dr. Cheng Fang. “We are also grateful for the 45-minute format, which allows us to present our data comprehensively.”

  • Talk: Wednesday, July 31, 2024, at 8 a.m.
  • Session: Developing Topics in Alzheimer’s Research
  • Location: Philadelphia, USA, and online

The abstract of the presentation will be published in the online version of Alzheimer’s & Dementia(R): The Journal of the Alzheimer’s Association following the conference.

Annovis Bio’s ongoing research and the promising results of buntanetap underscore its commitment to pioneering effective treatments for neurodegenerative diseases, bringing hope to patients and the scientific community alike.

For more information, visit the company’s website at www.AnnovisBio.com, and social channels
LinkedInX and YouTube.

NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://ibn.fm/ANVS

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