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Incremental Data Inhibits Progress on Alzheimer’s Drugs
The Alzheimer’s Association International Conference (AAIC) was held from the 24th to the 28th of July this year, and offered some fascinating insights and information regarding treatment of this cruel disease. According to this article in Forbes, the results revealed in the presentations on new drugs also emphasised the need for rich, plentiful data at all stages of the drug discovery pipeline.
The main problem is what Forbes reporter Matthew Herper terms “incremental data”. Biogen actually presented data from their drug, aducanumab, back in March. Three doses were trialled at the clinical stage in a 166-patient study. Initially the data suggested that, in terms of helping patients to function in day-to-day life, the drug was more effective as the dose grew higher; this appeared to be the case even though there are dose-dependent brain-swelling side effects.
In March, there was missing information on one dose. As of the AAIC it has been revealed that the results for that dose were not statistically significant, even though the results for a higher dose were. As consultant for Biogen Ronald Petersen put it, “[the data are] partially supportive but not convincing” and “the overall story does not change.”
The problem with situations like the one faced by Biogen is that investors are seeing no reason to allocate resources when, based on the available data, there is little obvious progress. Richer data from the earlier trial stages could have given a fuller perspective on dose dependency, side effects, and the likely performance of the drug when tested on humans.
There was slightly better news from Eli Lilly, which has been developing solanezumab. The drug has been in development for years, with two failed studies in 2012. However, the data presented at the AAIC demonstrated that a positive outcome has resulted from a delayed-start study conducted after one of the studies. A total of 1,322 patients who had participated in the original trial were all given the drug, whether or not they had previously been on the placebo. Once solanezumab had been given to the original placebo group, disease progression slowed to the point where they were on the same “level” as those who had been given the drug initially and were continuing to take it. This suggests that the drug does work, and investment will hopefully continue. It will just take time for more definitive evidence to emerge: the current study doesn’t end until late 2016.
The main problem with incremental data, as Herper points out, is that investors either lose faith or begin to “see things that are not there”. Definitive data has to be available from the pre-clinical stage onward; this facilitates both further development and the early ruling out of unsuccessful drugs.
For information on ActualHCA and how it offers richer data at early stages of the drug discovery pipeline, click here. For a fuller analysis of the way ActualHCA offers the opportunity for better analysis, read our white paper here. To read Matthew Herper’s piece in Forbes, click here.