Solanezumab is another failed Alzheimer's drug
Eli Lilly and Co ($LLY) announced today in a press release that two phase 3 Alzheimer's trials with their monoclonal antibody, solanezumab, failed to reach primary endpoints but that pooled data appeared to show a slowing of cognitive decline. Some analysts think this is a trial failure...
- Eli Lilly and Company Announces Top-Line Results on Solanezumab Phase 3 Clinical Trials in Patients with Alzheimer's Disease (NYSE:LLY)INDIANAPOLIS, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the primary endpoints, both cognitive and functional...
- Lilly shares rose in trading despite the news. However, hope that there was a silver lining to the data started to turn into hype by some media outlets and analysts:
On @MarkSchoenebaum call, he reminds that FDA guidance calls for functional AND cognitive improvement for approval. #solanezumab $LLY
Lilly & its Big Alzheimer's Bet Missed Primary Endpts.. But here's why some see a silver lining bit.ly/P7G5w7 #pharma $LLY #alzheimer
A bit surprised that some people are seeing positive news when $LLY solanezumab did NOT slow the progression of Alzheimer's #failedtrial- However, Alzheimer's patients and their caregivers should not have raised hopes from a hyped subset data that may be meaningless. None of the primary endpoints were met and some analysts and commentators considered this a failed trial:
@John_LaMattina @scotthensley Every time I see a 2ndary analysis like this the only hope being kept alive is the CEO's - to keep his job- @JohnCFierce @John_LaMattina @scotthensley let's be honest, taking comfort in subsets of secondary endpoints is a bit of a Hail Mary at best
- @JohnCFierce agree completely but seriously, pooling data from 2 trials in unspecified analysis is a small biotech trick.
- Absolutely. And it worked! RT @MaverickNY: agree completely but seriously, pooling data in unspecified analysis is a small biotech trick.
- @JohnCFierce can you imagine an oncology co announcing a failed trial and saying oh but we have a subset that sorta works, let's go w/ that!
@JohnCFierce @MaverickNY <pooling data in unspecified analysis is small biotech trick.>Trick occasionally used by Big Pharma: eg $ABT Xinlay- @DewDiligence @JohnCFierce it's always best to nail the subsets in ph 2 and then run your ph3 trials in the mostly likely group.
- Experts believe that if is a meaningful effect in a small sub-set of patients then Lilly should run another trial.
@scotthensley @JohnCFierce I hope that this isn't the case. It's going to cost a lot of $ for Lilly to show that this trend is real.- @sciencescanner @scotthensley @JohnCFierce If LLY really believes the data, they'll run another p-3 trial. Their actions will be revealing.
- @John_LaMattina @JohnCFierce @scotthensley in theory, that may well be needed by FDA if overall trial missed primary endpoints $$$$
- @MaverickNY @JohnCFierce @scotthensley Agree. But will LLY run another phase 3 program to demonstrate their faith?
- @MaverickNY They'd have to run another Phase III. I'd really like to see the data on this.
- Lilly may appear desperate for positive results in an indication such as Alzheimer's where there is a real unmet need for effective treatments and their late pipeline is thin:
@MaverickNY @natesadeghi LLY is in desperate pipeline shape, and has to grab at what they can. Combine that with desperate patients. . .
@scotthensley Patients and investors should demand better. Time for a CEO change. $LLY
Adam WrcakjoshAnother one??? Thts baaad.2012-10-31T17:45:56.505Z
