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Data from a phase 2/3 trial from Annovis Bio (NYSE:ANVS) for its Alzheimer’s disease candidate buntanetap has triggered six trading halts so far Monday morning trading due to volatility.
Prior to the end to the last halt at 1111a ET, shares were down ~53%.
While Annovis (ANVS) portrayed the data as statistically significant, the Street’s reactions indicate that the results could be a bit disappointing.
Results showed significantly higher improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo. For example, in a treatment group given three doses of buntanetap over three months, the 7.5 mg, 15 mg, and 30 mg cohorts showed responses of, respectively, 73.7%, 72%, and 87.5%. The placebo group saw a response of 27.3%.
The change in ADAS score was dose dependent with the 30 mg dose showing the best results. Improvements in the score of the 7.5 mg, 15 mg, and 30 mg groups, were, respectively, 2.19, 2.79, and 3.32.
However, the study found no statistically significant differences in two other endpoints, ADCS-CGIC and ADCS-AGL. Annovis said that because of the relatively small number of patients enrolled in each cohort, there were “minor expectations for a statistically significant outcome” in either of these endpoints.
The study was designed as randomized, double-blind, and placebo-controlled in patients with mild to moderate Alzheimer’s. Patients received one of three doses of buntanetap or placebo. A total of 353 patients were enrolled, and 325 patients completed the study.
Annovis (ANVS) said it will next ask the U.S. FDA for an end of phase 2 meeting. “We expect to discuss the data with the FDA in the next two to three months and then move on to the next Phase III study to confirm and expand these findings in an 18-month disease-modifying trial focusing on biomarker-positive early AD patients.”
It is important to note that the phase 2/3 study was in mild to moderate AD patients, while the planned phase 3 trial will be in early AD patients.
