Annovis Bio’s Buntanetap Proven Safe, Effective in High-Risk Alzheimer's Patients; Investor Call for Findings Discussion

June 11, 2024 -- Annovis Bio Inc. (NYSE: ANVS), a late-stage drug platform company dedicated to developing innovative therapies for neurodegenerative diseases such as Alzheimer's (AD) and Parkinson's disease (PD), has announced positive results from its recent Phase II/III study of its leading drug candidate, Buntanetap. The study demonstrated statistically significant efficacy and safety in both carriers and non-carriers of Apolipoprotein E4 (APOE4), a genetic factor in Alzheimer's disease.

Key Findings:
In patients with early AD, specifically those with a Mini-Mental State Examination (MMSE) score between 21-24, Buntanetap showed substantial improvement. The study results highlighted a statistically significant dose-response in ADAS-Cog11 scores. Patients experienced a -3.3 point improvement over baseline and a -2.3 point improvement when compared to placebo. 

For APOE4 carriers treated with a 15mg dose of Buntanetap, the results were equally promising. These patients showed a -3.15 point improvement in ADAS-Cog11 scores. Importantly, Buntanetap’s safety profile was comparable across both APOE4 carriers and non-carriers, with no reported instances of Amyloid-Related Imaging Abnormalities (ARIA).

The study comprised 159 APOE4 carriers, including 33 homozygotes and 126 heterozygotes, alongside 159 non-carriers. Recent research published in Nature Medicine has redefined APOE4 homozygosity as a distinct genetic variant of Alzheimer's, necessitating tailored prevention strategies and therapeutic approaches. This reclassification underscores the importance of targeting this specific demographic for treatment development.

Dr. Samuel Gandy, an Alzheimer’s researcher from Mount Sinai, has highlighted the elevated safety risks associated with anti-amyloid drugs, such as Leqembi, for APOE4 homozygotes. These drugs have been linked to severe side effects, including brain swelling and bleeding, prompting the Food and Drug Administration (FDA) to issue a black-box warning last year for individuals with two copies of the APOE4 gene. However, Buntanetap did not present increased safety risks compared to placebo, even among APOE4 carriers.

Given these promising results, Annovis Bio plans to initiate an 18-month Phase III trial focused on biomarker-positive early AD patients. This trial aims to further substantiate the efficacy and safety of Buntanetap and will be conducted under the FDA’s guidance.

Annovis Bio will host an investor call to discuss these findings and outline future development plans for Buntanetap. The call is scheduled for June 11, 2024, at 4:30 PM ET.

About Buntanetap:
Buntanetap, formerly known as Posiphen or ANVS401, aims to combat neurodegeneration by inhibiting the formation of several neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43. By enhancing synaptic transmission and axonal transport while reducing neuroinflammation, Buntanetap seeks to reverse neurodegeneration in AD, PD, and other related diseases.

About Annovis Bio Inc.:
Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. is committed to addressing neurodegeneration linked to diseases such as AD and PD. The company’s innovative strategy targets multiple neurotoxic proteins with the goal of restoring brain function and improving patients' quality of life.

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