Shares Eli Lilly And Co. (NYSE: LLY) jumps around 6% to $428 in pre trading session on Wednesday after In a highly monitored late-stage trial, an experimental Alzheimer’s medicine produced by Eli Lilly and Co delayed cognitive decline by 35%, the company said on Wednesday, increasing hopes for a second viable therapy for the brain-wasting illness.
Donanemab accomplished all of the trial’s primary and secondary objectives. According to Lilly, it reduced the progression of Alzheimer’s disease by 35% to 36% compared to a placebo in 1,182 persons diagnosed with early-stage illness based on brain deposits of a protein called amyloid and intermediate levels of a second protein called tau. The remaining 552 individuals in the experiment had high tau levels, indicating that they would be less likely to react to therapy.
Donanemab was proven to decrease Alzheimer’s progression by 22% using a Lilly-developed scale to evaluate cognition and activities of daily living, and by 29% using a more generally used dementia progression scale.
Using that dementia scale, study data released last year revealed that Eisai Co Ltd and Biogen Inc’s Leqembi lowered the rate of cognitive loss in individuals with early Alzheimer’s by 27% compared to a placebo.
Lilly reported that in the donanemab treatment group, brain swelling, a documented adverse effect of this class of medicine, occurred in 24% of patients, with 6.1% having symptoms. There was brain hemorrhage in 31.4% of the donanemab group and 13.6% of the placebo group.
The medicine was linked to brain enlargement in roughly 13% of participants in the Leqembi Phase 3 study.
According to Lilly, the incidence of significant brain swelling was 1.6% in the donanemab research, which included two patients whose deaths were linked to the disease and a third who died following an occurrence of serious brain swelling.
Dr. Eric Reiman, executive director of the Banner Alzheimer’s Institute, which is conducting a donanemab Alzheimer’s prevention research in presymptomatic patients, said he was “very excited” by the findings. “Clearly, one saw benefits here, but there is some risk that needs to be considered,” he added.
The company stated that it intends to submit for customary US clearance by the end of June and with other nations’ authorities shortly thereafter.
“There are risks in medicine, but when you look at these results in the context of a fatal life-threatening disease, I think these results are quite meaningful,” Lilly Neuroscience CEO Anne White told Reuters.
The business also stated that at 12 months, 47% of donanemab patients in the 18-month trial showed no illness progression, compared to 29% of the placebo group.
Following the failure of two similar medicines developed by partners Eisai and Biogen – Leqembi and Aduhelm – to gain traction with doctors or insurers after showing little evidence that it slowed cognitive decline, Lilly’s drug is likely to become the third in its class on the market.
Leqembi is presently going through the FDA’s regular review procedure, which will consider its influence on cognitive function, with a decision expected by July 6. According to the Alzheimer’s Association, more than 6 million Americans have Alzheimer’s disease, with the number expected to climb to over 13 million by 2050.
