Failure continues to haunt the Alzheimer’s field.
The latest blow came late on Tuesday at the hands of Merck, with news that its Phase 2/3 trial of verubecestat had been stopped due to a lack of efficacy.
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The Data Monitoring Committee for its EPOCH study in mild-to-moderate Alzheimer’s disease concluded that there was “virtually no chance of finding a positive clinical effect.”
Merck shares fell 1.5 percent as after-hours trading began.
According to ClinicalTrials.gov the EPOCH study was slated to run from Nov. 2012 to July 2019.
The silver lining is that the drug’s safety profile remains sound, justifying the continuation of Merck’s other late-stage trial of verubecestat in patients with a subtype of Alzheimer’s known as prodromal AD.
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The question of efficacy is far more deeply-rooted.
Verubecestat targets BACE1, an enzyme associated with the production of amyloid beta. Many in the scientific community believe amyloid plays a causal role in the pathogenesis of Alzheimer’s disease. By Inhibiting BACE1, verubecestat should theoretically have reduced the formation of amyloid plaques in patients’ brains and slowed symptom progression.
This clearly hasn’t eventuated, said Andrew Budson, an Alzheimer’s clinician, professor of neurology at Boston University and author of an upcoming book about the disease. In an email, Budson said many different approaches are needed to increase the odds of success.
BACE inhibitors stop the formation of beta amyloid. If the drug worked as was intended and yet did not stop disease progression, it might suggest that treatment needs to be initiated prior to the mild-to-moderate stage. Although I remain hopeful that anti-amyloid pharmacological approaches to treating Alzheimer’s disease will be beneficial, I cannot deny the fact that each negative trial result reduces my hope that the next one will be successful. This negative result for an amyloid-based approach also makes the current efforts to find additional symptomatic therapies and those that can reduce downstream neurodegeneration more important.
Today’s results will likely reverberate throughout the field, negatively impacting companies invested in the amyloid hypothesis.
It follows other high-profile failures, such as Eli Lilly’s solanezumab. In December, solanezumab flopped in its second major Phase 3 trial. The drug attempted to bind beta-amyloid in the bloodstream to prevent it from accumulating in the brain.
Lilly has also invested in BACE inhibitors, signing a partnership with AstraZeneca in 2014 and proceeding into a pivotal Phase 2/3 trial. Data from that study is expected in May 2019.
Biogen and Eisai are also pursuing an oral BACE inhibitor, E2609. In 2016, the companies moved the drug into a Phase 3 trial using the highest of three doses evaluated in the Phase 2 study.
Once again, no major safety issues have arisen. But the pressure is on to prove efficacy.
Photo: flytosky11, Getty Images
