Wyeth & Elan: More Questions in Alzheimer’s Study Results (WYE, ELN)
Today was the long awaited Alzheimer’s drug data presented from Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE). The companies presented detailed results from their 18-month Phase II study of bapineuzumab in patients with mild to moderate Alzheimer’s disease.
The study was on 234 randomized with findings reported on 229 patients, and efficacy was measured from a baseline of 78 weeks. The data looked very positive on the surface with safety and efficacy results supporting the design of an ongoing global Phase III program.
Some data is mixed and shares were hit as a result. It showed statistically significant and clinically meaningful effects were observed in multiple endpoints in ApoE4 non-carriers. The company also noted that pre-specified efficacy analysis did not reach significance in the total population.
Favorable directional changes were seen in some endpoints in ApoE4 carriers, warranting further study. The post-hoc anlysis showed statistically significant and clinically meaningful benefits in important subgroups.
You can read about the full results here. There were measurements of less or slower brain shrinkage combined with better memory test results observed in the study, and if our data is correct that would be superior to any existing treatments and is probably above other study reports to date.
The problem is the pre-specified efficacy analysis as well as a few deaths in the trial (which were noted as “unbelieved to be from the drug” despite no deaths in teh placebo group.
This data was shown at the Alzheimer’s Association’s International Conference on Alzheimer’s Disease 2008 in Chicago, Illinois.
Shares are getting slapped down in after-hours. Wyeth stock is down 8.5% at $41.25 and Elan stock is down 15% at $28.49 in after-hours trading. Both stocks had been higher initially ahead of the data. This looks more and more like mixed data, and unfortunately it looks like Alzheimer’s patients have a long way to go before even any meaningful help will arrive.
Jon C. Ogg
July 29, 2008 (5:45 PM EST)