By Adam L. Cataldo
Annovis Bio, a clinical-stage drug platform company based in Berwyn, Pa., recently announced positive findings from an independent statistical group regarding its Phase 2/3 study on Alzheimer’s disease. The company revealed that there is no need to include additional patients, allowing the study to continue as planned.
Market Reaction and Future Outlook
Following this news, Annovis Bio’s shares experienced a significant boost, rising by 16% to $8.96 during midday trading on Thursday. However, despite this positive development, the stock still remains down by 33% this year.
Annovis Bio’s study aims to enroll 320 patients with mild to moderate Alzheimer’s disease. Participants will be randomly assigned to receive varying doses of buntanetap or a placebo once per day. The company is focusing on evaluating the impact of buntanetap on cognition and activities of daily living—the two co-primary endpoints of the trial.
Pre-Planned Interim Analysis
The company has received the results of the pre-planned interim analysis, which included data from 107 patients across all cohorts after six weeks. This analysis confirmed that the trial should continue as planned and maintain its current size to maintain statistical power for both co-primary endpoints.
Key Endpoints of the Trial
The trial will assess the change from baseline to the end of treatment in two key factors: Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) and Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change (ADCS-CGIC). These measures are vital in understanding the impact of the treatment on cognition and overall daily functioning.
In conclusion, Annovis Bio’s Phase 2/3 study has received promising news, allowing it to proceed as scheduled without the need for additional patients. These developments bring hope for advancements in the treatment of Alzheimer’s disease.