Annovis Bio Inc (NASDAQ:ANVS) shares plunged after the company released data from its Phase 2/3 Alzheimer study of buntanetap in mild to moderate Alzheimer’s patients.
Investors are reacting as during the trial, ADCS-CGIC in all groups of patients barely changed, with no statistically significant difference observed.
The 15mg and 30mg buntanetap groups slightly improved in mild Alzheimer’s patients.
The ADCS-CGIC is a clinician-rated measure of global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
The company also observed a large placebo effect in ADCS-ADL, with 15mg and 30mg buntanetap groups showing similar improvements with no statistical difference between the groups.
The ADCS-ADL is an informant-rated measure of functional impairment scored from 0 to 78, where a higher score indicates less impairment.
Annovis Bio observed improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo.
ADAS-Cog is an objective measure of cognitive impairment, scored from 0 to 70, with a higher score indicating more impairment.
The analysis focused on biomarker-positive early AD patients (MMSE 21-24, pTau217/tTau≥4.2%) and found that ADAS-Cog 11 was highly statistically significant at all three dose levels and in the combined dose levels compared to placebo as well as to baseline.
At the end of 3 months of treatment, the placebo group demonstrated slight improvement but was not significantly different from the baseline.
All three buntanetap treatment groups showed statistically significant improvement from their corresponding baseline (7.5mg improved 2.19 (0.87), p=0.013; 15mg improved 2.79 (0.81), p=0.001; 30mg improved 3.32 (0.82), P<0.001).
The 15mg and 30mg treatment groups also showed statistically significant improvement relative to the placebo group (p=0.042 and 0.015, respectively).
Buntanetap was very well tolerated. The safety profile observed in this study was consistent with prior clinical trials.
The company says the short study shows a symptomatic effect with a possible disease-modification trend according to the tau data. The next study will have a longer duration, improved design and be statistically powered to validate symptomatic improvement and disease-modification.
The company plans to measure additional biomarkers for inflammation and axonal and synaptic functions.
Annovis Bio expects to discuss the data with the FDA in the next two to three months and then move on to the next Phase 3 study to confirm and expand these findings in an 18-month disease-modifying trial focusing on biomarker-positive early patients.
Price Action: ANVS shares are down 50.6% at $8.90 at the last check Monday.
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