Annovis Bio’s Alzheimer’s Drug Shows Promise in Phase II/III Trial

Annovis Bio

MALVERN, PAAnnovis Bio Inc. (NYSE: ANVS) has announced promising results from its recent Phase II/III clinical trial for its lead drug candidate, Buntanetap, targeting Alzheimer’s disease (AD). The study demonstrated statistically significant efficacy and safety in both carriers and non-carriers of the genetic marker Apolipoprotein E4 (APOE4), a known risk factor for Alzheimer’s.

The company will discuss these findings in detail during an investor call today at 4:30 PM ET.

Key Findings

In patients with early-stage Alzheimer’s disease, Buntanetap showed a notable dose-response improvement in cognitive function as measured by ADAS-Cog11 scores. Specifically, patients exhibited a -3.3 points improvement over baseline and a -2.3 points improvement compared to the placebo group.

For APOE4 carriers—a genetic group particularly vulnerable to AD—those treated with 15 mg of Buntanetap showed a -3.15 improvement in their ADAS-Cog11 scores. Importantly, the drug demonstrated consistent safety across both APOE4 carriers and non-carriers, with no reported instances of Amyloid-Related Imaging Abnormalities (ARIA), a common side effect associated with other anti-amyloid drugs.

The study included an equal number of APOE4 carriers and non-carriers, with 159 participants in each group. The carrier group comprised 33 homozygotes and 126 heterozygotes.

Scientific Context

Recent research published in Nature Medicine has highlighted the critical need for individualized treatment strategies for APOE4 homozygotes, who are almost certain to develop Alzheimer’s if they live long enough. This study underlines the necessity for specific therapeutic interventions for this high-risk group.

Dr. Samuel Gandy, an Alzheimer’s researcher at Mount Sinai, noted the increased safety risks for APOE4 homozygotes treated with existing anti-amyloid drugs like Leqembi, which have been linked to serious side effects such as brain swelling and bleeding. The FDA even required a black-box warning for Leqembi due to these concerns. However, Buntanetap has shown no such increased safety risks compared to placebo, making it a potentially safer option for this vulnerable population.

READ:  Vishay Precision Group to Present at Virtual Equity Conference
Buntanetap’s Promising Results for APOE4 Carriers

The success of Buntanetap holds significant implications for the future of Alzheimer’s treatment. Current therapies often come with severe side effects, particularly for patients with the APOE4 gene. Buntanetap’s ability to improve cognitive function without these adverse effects could represent a major breakthrough.

Moreover, the study’s focus on APOE4 carriers addresses a critical gap in Alzheimer’s research and treatment. Given the near certainty of AD development in APOE4 homozygotes, finding effective and safe treatments for this group is crucial. Buntanetap’s promising results could pave the way for more personalized and effective Alzheimer’s therapies.

Annovis Bio’s Buntanetap Revolutionizing Alzheimer’s Treatment Landscape

Encouraged by these results, Annovis Bio plans to initiate an 18-month Phase III trial focusing on biomarker-positive early AD patients. This upcoming study aims to further validate Buntanetap’s efficacy and safety profile under FDA guidance.

The investor call today will also touch upon a recent New York Times article that discusses the serious implications for APOE4 carriers, emphasizing the urgency and importance of developing safe and effective treatments for this high-risk group.

In summary, Annovis Bio’s recent findings suggest that Buntanetap could become a vital tool in the fight against Alzheimer’s, offering hope to patients and families grappling with this debilitating disease. The company’s continued research and forthcoming trials will be closely watched as they hold the potential to reshape the landscape of Alzheimer’s treatment.

For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and Microsoft Start.