Lilly Alzheimer’s drug fails in latest study
“Lilly remains committed to Alzheimer’s research as we have been for almost 30 years, and our portfolio includes many other promising approaches”.
“After positive news last summer, we had high hopes for this drug to become the first to slow down Alzheimer’s disease”. Based on these results, the company not surprisingly will not file for approval. An analysis of the Phase III Alzheimer’s drug pipeline, conducted by ResearchersAgainstAlzheimer’s (RA2), shows that there are now 22 Alzheimer’s drugs in Phase III clinical trials, 18 of which may be on track to launch in the next five years. But the trial found no statistically significant affect on cognitive decline in patients taking the drug, as opposed to those who took a placebo.
“As far back as”. The yield on that note is at its highest in more than six years.
The University of Southern California director of the California Alzheimer’s Disease Center, Dr. Lon Schneider shared, “We’re much more really appreciative of how complex this disease is”.
Lilly’s setback raised questions in the strategy of targeting the beta amyloid protein, believed to cause brain plaques, which Biogen’s aducanumab also targets.
The drug was created to fight the formation of amyloid plaques-buildups of certain proteins in the brain that scientists have posited may be behind the symptoms of Alzheimer’s. As these plaques accumulate, they diminish cell-to-cell signaling, which may cause Alzheimer’s disease symptoms. Lilly and AstraZeneca have partnered on one BACE inhibitor; others are being developed by Merck & Co. and by Eisai Inc. with Biogen. And other drugs testing this hypothesis have failed.
Anderson suggested dosing decisions by Lilly could have contributed to solanezumab’s failure. Executives said the results reflected cost cuts. “(Lilly) never seemed to have a great answer for why they picked the solanezumab dose they did”. Although the results from the study favored solanezumab, the magnitude of the treatment differences were small. “We can’t disregard these ongoing trials and their findings will now be more important than ever in shaping the search for disease-modifying treatments for Alzheimer’s”.
The full results are expected to be presented in December at the Clinical Trials on Alzheimer’s Meeting in San Diego, but clinicians have already labelled the news as “disappointing” and a setback for patients and their families.
It is too soon to know whether targeting tau or other approaches will work. In response, shares fell 11% in morning trading. Other drugmakers also slumped.
Ricks said Lilly stands by July projections, calling for revenues to grow an average of 5 percent between by the end of the decade, and calling for margins to improve without solanezumab. “We have a lot going on beyond Alzheimer’s, launches in diabetes and oncology and immunology”.
“To be successful in clinical trials, new Alzheimer’s drugs need to show benefits for memory and thinking that outweigh any effect of a placebo or “dummy” treatment”, he added. The U.S. currency hasn’t been this strong since March 2003.
In his own investor note, Evercore ISI analyst John Scotti pointed out that Lilly drug reduced plaque “minimally” in an analysis of patients, after adjusting for the region of the brain that was measured. “By increasing the rate of clearance of amyloid with solanezumab, we are making the brain younger in a sense”, Siemers told TIME earlier while describing the compound.
“We’re saddened and disappointed”, said Maria Carrillo, chief science officer at the Alzheimer’s Association in Chicago, which funds research programs and lobbies for more federal money to finance studies.