The Alzheimer's drug bapineuzumab failed miserably in one of the biggest Phase III studies of the year. But the drug--once a megablockbuster hopeful at Johnson & Johnson ($JNJ) and Pfizer ($PFE)--had an impact on key biomarkers for the disease, leading investigators to urge a major new effort to see if the drug could work to delay the onset of the memory-wasting affliction.
The Phase III "bapi" study was designed as the ultimate test of the beta amyloid theory; the idea that if you cut the levels of the toxic protein in patients' brains you could ameliorate symptoms of the disease. But over the past two years researchers in the field have come to believe that anyone who suffers from a moderate case has already been subjected to years of brain damage. So the scientific field has shifted its sights away from fully developed cases to high-risk populations or patients with a very early-stage case, before the damage has been done. And some experts were excited to see proof of concept data in the bapi data now being released, with some advocating that Eli Lilly's ($LLY) solanezumab should also be repurposed following its failed Phase III.
"The disease begins 10 to 20 years before there are any symptoms, and now we are better at detecting some of those changes," Brown University Professor Steve Salloway tells Bloomberg. "We want to intervene as soon as possible to keep the brain healthy. Drugs like this that lower amyloid will probably have their greatest impact earlier on. We have to test that."
Exhibit A in the case to test bapineuzumab earlier is the high dose's impact on amyloid beta seen in brain scans and phospho-tau levels in the spinal fluid of patients, indicating a lower rate of brain cell death. But MRIs also demonstrated an equal amount of brain shrinkage in both the placebo group and the drug arm.
There's a major hurdle. Patients taking bapineuzumab experienced a higher risk of fluid buildup, bleeding in the brain and seizures, reports Bloomberg. That raises the prospect that a high-risk population of otherwise healthy people could be exposed to serious safety risks--not an alluring prospect for anyone in drug development. Advocates now, though, are hoping that the government will pay to see if these drugs work to delay the onset of disease.
- here's the Bloomberg report
- and the Reuters story
- here's FierceMedicalDevices' take on beta amyloid imaging
Special Report: The Alzheimer's pipeline: What's next?
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"Hard to justify": Experts don't see moving forward with "bapi" and solanezumab given risks.
Started by @JohnCFierce