Summary:
SAVA Ph2 Open label study topline data was reported today, 1/24/23
While the data was reported as positive, the market did not respond well to the data
We have compared this data with previous open label study data from 2021 to determine if the data does seem to be positive
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Cassava Phase 2 open label 12 month topline data was reported today. While the company stated this data was “positive”, the market did not respond accordingly and stock is down ~20% today.
Some have reacted on social media today that the data shows it is no better than control. Others have criticized the way biomarker data was analyzed/presented. To better understand the significance of today’s data we compared this data to previous SAVA open label study data, and carefully analyzed today’s data/press release.
In Figures 1 and 2 from the data reported today, “placebo decline” was mentioned for the Simufilam data, however as far as we can tell this open label study did not include a placebo. A placebo could not be compared then, and we believe this is the mean or medium for the Simufilam-treated patients.
Fig 1.
Fig 2.
Compared to the data in July 2021 (9 month data), the 12 month data today showed a lower number of patients with an improvement in their ADAS-Cog score (66% improvement at 9 months and 47% improvement at 12 months), and a lower score improvement (only 0.5 point improvement vs >3 point improvement in 2021). There also was a higher percentage of patients that had an ADAS-Cog score decline.
There also hasn’t been any new CSF biomarker data since the 6 month data in July 2021 from 25 patients. This data was analyzed blindly by an outside lab, and no further sampling was completed.
See Table 1 for a comparison of the 2021 data to today's data.
Table 1.
While data from 2021 was just from 50 patients in the study, this data now includes all 200 patients, so there is a thought that the first 50 patients could have been cherry picked, leading to the better data.
While this data still looks promising, it is hard to say if the data is positive because there is no control and the current data is open label. Again, the placebo decline mentioned in Figures 1 and 2 is the Simulifam mean or median with confidence intervals from the active arm (the only arm) of the current open label trial. It will be interesting to see topline data from the Cognition Maintenance Study later in 2023 (a randomized, controlled trial) as well as data from the Phase 3 RETHINK-ALZ and REFOCUS-ALZ trials. See Table 2 for other upcoming Alzheimer's readouts.
Table 2.
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