Undeterred by its past failures in the Alzheimer's field, Eli Lilly ($LLY) has invested more in research on drugs that target tangles of tau in the brains of patients with the memory-robbing disease. And the company is open to exploring combo treatments that home in on multiple culprits in the dementia, a company official tells The Wall Street Journal.
Indianapolis-based Lilly has stayed the course in seeking blockbuster drugs for the complex disease after suffering defeats in two Phase III trials last year of an amyloid-targeting therapy called solanezumab. Up in smoke went the near-term prospects of the antibody becoming the blockbuster that Lilly badly need, but the company said more trials for sola in patients with early-stage disease are in the offing based on evidence of efficacy in that subgroup in the failed Phase III trials. And now the company has added preclinical work to test the tau theory after dedicating years and millions to amyloid.
"Today, we don't have any disease-modifying drugs that are approved. Hopefully, in the future we'll have multiple disease-modifying drugs and we'll be exploring their use individually as well as together," Dan Skovronsky, Lilly's vice president of tailored therapeutics and CEO of its Avid Radiopharmaceuticals unit, told FierceBiotech in an interview. "Maybe this will turn out in the same way that HIV and cancer treatment have turned out where we try drugs in sequence and also try combinations of drugs against different pathways to help patients."
Lilly has grabbed imaging tracers from Siemens, providing tools to potentially gauge the impact of treatment with therapies that target both the amyloid and tau pathways, Skovronsky said. Clinical trials of tau-targeting drugs from the company could begin in a couple of years.
In addition to Lilly, Pfizer ($PFE) and Johnson & Johnson's ($JNJ) amyloid-targeting therapy from Elan called bapineuzumab also crashed and burned in Phase III studies, giving investigators more reason to seek alternative strategies to attacking the disease, for which there are no approved drugs that reverse progression of symptoms. Roche ($RHHBY), Lilly and others have recently pushed ahead with early research of therapies home in on targets in the tau pathway, which centers on the tau protein found in knotty tangles in neurons and marks the severity of disease in Alzheimer's patients.
By no means is Lilly the first outfit to weigh the possibility of a combo approach against the disease. Like Lilly, Roche is pursuing both the amyloid and tau pathways to treat the disease. Roche grabbed rights to an anti-tau contender from AC Immune at the same time the company's Genentech unit embarks on a major study of an anti-amyloid therapy for use before Alzheimer's advances. And venture backers have also poured money into TauRx to lead the way in the tau-targeting approach to treatment of Alzheimer's.
Yet some pockets of the industry believe all these efforts are doomed. Lilly, Merck ($MRK) and J&J/Pfizer have been criticized for betting large chunks of their R&D budgets on development projects with very slim chances of success. And Sanofi ($SNY) CEO Chris Viehbacher made waves in the industry this week with his comments about staying out of the field.
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Editor's note: Updated with comments from Dan Skovronsky, Lilly's vice president of tailored therapeutics and CEO of its Avid Radiopharmaceuticals unit.