MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) has made a breakthrough in an ongoing study of Alzheimer’s disease. Their novel Alzheimer’s drug, buntanetap, which specifically targets neurotoxic proteins, has undergone a successful Phase II/III clinical trial. The study results make a compelling case for the drug’s efficacy in early-stage Alzheimer’s patients, setting the stage for a pivotal Phase III trial.
Buntanetap is an orally administered molecule that binds selectively to a specific genetic sequence within the mRNA of amyloid precursor protein (APP) and other neurotoxic proteins. This bond inhibits the production of these toxic proteins, including amyloid beta, tau, alpha-Synuclein, and TDP43. The impacts? Fewer neurotoxic proteins, and potentially, a slowed progression of Alzheimer’s disease.
In a Phase II/III trial, buntanetap was administered to over 325 patients across the United States who were diagnosed with mild to moderate Alzheimer’s disease. During the 12-week study, patients received one of three doses of buntanetap in addition to their regular care.
The results were promising. On a key mental measurement scale — the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11), which assesses cognition and everyday activities — patients with mild Alzheimer’s showed a significant improvement. Across all three dosage levels when compared to the control group, patient scores increased significantly. Even more compelling, the highest results were observed in early-stage Alzheimer’s patients, hinting at the drug’s potential effectiveness in the early stages of the disease.
Interestingly, the study revealed that the level of improvement directly correlated with the patient’s disease severity at the start of the trial. Mild Alzheimer’s patients had a more pronounced response to buntanetap treatment than those with more advanced stages of the disease
Despite the success with the ADAS-Cog 11, not all measurements saw significant improvements. There were minor improvements in patient’s daily life activities, assessed using the Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change (ADCS-CGIC). However, these were not statistically significant. This may be due to the subjective nature of these assessments and the hopeful expectations of patients and caregivers, potentially resulting in a stronger placebo effect.
Despite these nuances, Buntanetap’s safety credentials are impressive. The drug was found to be well tolerated across the board, with any adverse events being minor and not directly attributable to the drug. This consistent safety record aligns with previous clinical trials.
In short, as a safe, orally administered once-daily drug, Buntanetap improves cognition in early-stage Alzheimer’s patients. Its therapeutic efficacy correlates strongly with the severity of the disease at the start of treatment. Also, ADAS-Cog 11 scores in patients improved, on average, by 3.3 points, a substantial and statistically significant result.
The implications? A drug like buntanetap could revolutionize Alzheimer’s care. Not only does it have the potential to improve cognitive function in the short term, but it might also slow disease progression over time, a significant finding given the chronic nature of Alzheimer’s disease.
Based on these encouraging results, Annovis Bio is planning for a longer and larger Phase III trial to further validate symptomatic improvement and disease-modification. The company will also be reporting its findings to the FDA and holding discussions on future study plans.
The science may be complex, yet the bottom line is clear: Annovis Bio’s Buntanetap brings hope for those living with Alzheimer’s and those tasked with their care. As we peel back the layers of this devastating disease, innovations like buntanetap could be a significant weapon in our arsenal against Alzheimer’s.
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