Eisai, Biogen Alzheimer’s drug slows cognitive decline, security for some turns into focus By Reuters

By Deena Beasley

SAN FRANCISCO (Reuters) – An experimental Alzheimer’s illness drug from Eisai and Biogen (NASDAQ:) slowed cognitive decline in a closely-watched trial however might carry a threat of harmful negative effects for sure sufferers, in response to new information introduced on Tuesday.

The drug, lecanemab, was related to a sort of mind swelling in 12.6% of trial sufferers, a aspect impact beforehand seen with related medicine. Fourteen % of sufferers had microhemorrhages within the mind – a symptom linked to 2 latest deaths of individuals receiving lecanemab in a follow-on research – and 5 sufferers suffered macrohemorrhages.

The businesses mentioned in September that the 18-month trial, which enrolled almost 1,800 members with early-stage Alzheimer’s, discovered that therapy with lecanemab decreased the speed of decline on a scientific dementia scale (CDR-SB) by 27% in comparison with a placebo.

“All of those amyloid-lowering medicine carry a threat for elevated mind hemorrhage,” mentioned Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota. “I believe the first outcomes, the secondary outcomes, the amyloid-lowering is fairly spectacular.”

The trial confirmed no profit on the CDR-SB measure for some sufferers with a genetic threat of growing the mind-wasting illness.

About 16% of trial members had two copies (homozygous) of the APOE4 gene variant identified to boost the danger of growing Alzheimer’s, 53% had one copy of the gene (heterozygous), and 31% have been noncarriers.

“For that small group of homozygous sufferers, in the case of CDR-SB we do not see a sign favoring lecanemab,” Ivan Cheung, Eisai’s U.S. chairman, mentioned in an interview. He advised that could possibly be as a result of homozygous research sufferers who got a placebo fared higher than anticipated.

The APOE4 carriers did present enchancment on the trial’s secondary objectives, together with different measures of cognition and every day perform. Total, lecanemab sufferers benefited by 23% to 26% in contrast with a placebo on these secondary trial objectives.

“I imagine it is an essential profit that can justify full approval. However in fact, we would like a much bigger profit,” mentioned Dr. Paul Aisen, director of the College of Southern California Alzheimer’s Therapeutic Analysis Institute and a co-author of the research. He mentioned lecanemab is probably going to supply larger profit if given earlier within the illness, “earlier than you have gathered sufficient irreversible injury to be inflicting signs.”

Detailed information from the research have been introduced on the Medical Trials on Alzheimer’s Illness assembly in San Francisco and revealed within the New England Journal of Medication.

PROOF OF AMYLOID THEORY

Eisai believes the trial outcomes show a longstanding concept that removing of sticky deposits of a protein known as amyloid beta from the brains of individuals with early Alzheimer’s can delay advance of the debilitating illness.

At 18 months, 68% of trial members handled with lecanemab had amyloid clearance, Eisai mentioned.

On Sunday, the journal Science reported the loss of life of a 65-year-old girl who was being handled with lecanemab. After struggling a stroke, the girl acquired a sort of drugs often called tissue plasminogen activator to clear blood clots and suffered a mind hemorrhage.

Earlier this yr, Stat reported that an 87-year-old man within the research, who was on the blood thinner Eliquis, additionally developed a mind hemorrhage and died.

Eisai mentioned it believes that the 2 deaths “can’t be attributed to lecanemab.”

Cheung mentioned Eisai has protocols in place for monitoring mind swelling and sees no want for restrictions on which sufferers could be eligible for lecanemab therapy.

Dr. Howard Fillit, chief science officer on the Alzheimer’s Drug Discovery (NASDAQ:) Basis, mentioned docs at all times steadiness the advantages and dangers of therapies. “Presently, I’d hesitate to present this drug to somebody on blood thinners,” he mentioned.

The U.S. Meals and Drug Administration is slated to resolve by Jan. 6 whether or not to approve lecanemab underneath its “accelerated” evaluate program, which requires proof {that a} drug can impression a biomarker related to a illness, reminiscent of discount of amyloid beta within the mind.

No matter that call, Cheung mentioned Eisai plans to quickly thereafter file for normal FDA approval of the drug, primarily based on its latest efficacy and security information. The corporate additionally plans to hunt approval in Europe and Japan.