Biotech
The patient numbers are small; only 24 patients remained in the study at 20 months. This makes it hard to draw any good conclusions on Alzhemed's efficacy. The use of historical control data -- especially 12-year-old data -- also is dubious because Alzheimer's care has certainly improved since then.
But the biggest red flag, in my mind, is that these data are potentially biased because it excludes patients who were performing poorly on Alzhemed. Of the 42 patients who started the extension study, 18 -- or 43% -- had dropped out by 20 months. But the dropped patients weren't included in the efficacy analysis. At least six of these dropped patients stopped taking Alzhemed because of "perceived lack of efficacy," according to the published report. Excluding these patients from the analysis likely makes Alzhemed appear more efficacious than it really is. If it's hard to extract any confidence in Alzhemed from the phase II study, what about the ongoing phase III studies? Is there preliminary data there that might be used as a proxy to predict the study's final outcome? Neurochem says such data do exist. The company has compiled blinded efficacy data combining patients on Alzhemed and placebo that it says point to an "encouraging trend" in favor of the drug, The chart below is the data that Neurochem's Bellini showed investors at the JPMorgan conference. Like the chart above, smaller changes in the mean ADAS-cog score represent a slower loss of cognition and a better outcome for patients.| Blinded results from Phase III Alzhemed study 520 patients followed for 18 months Mean change in ADAS-cog score from baseline |
||||||
| Blinded mild patients | Blinded moderate patients | |||||
| n=404 | n=116 | |||||
| improved/stable | 41% | -1.6 | 17% | -1.3 | ||
| slow progression | 23% | 4.5 | 16% | 4.4 | ||
| progression | 36% | 13.8 | 66% | 15.8 | ||
| Source: Neurochem presentation Jan. 2007 | ||||||
| Mild patients | 5.3 point progression |
| Moderate patients | 10.91 point progression |
| Weighted average for total | 6.6 point progression |
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