Eli Lilly Says New Data Can Potentially Provide Path To Improved Donanemab Profile By Lower Risk Of Imaging Abnormalities In Patients With Early Alzheimer's

On Tuesday, Eli Lilly And Co LLY released results from the TRAILBLAZER-ALZ 6 Phase 3b study to investigate different dosing regimens of donanemab and their effect on amyloid-related imaging abnormalities with edema/effusion (ARIA-E) in adults with early symptomatic Alzheimer’s disease.

ARIA-E is a type of MRI finding that can occur in patients with Alzheimer’s disease who are taking anti-amyloid beta (Aβ) immunotherapies.

Also Read: Eli Lilly Alzheimer’s Drug Faces Tough Road In UK, Price Watchdog NICE Says Donanemab Is Not Cost-Effective

The data showed a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer’s disease.

Donanemab is approved under the brand name Kisunla in the United States, Japan, Great Britain, and other countries.

Pharmacokinetic (PK) analysis demonstrated equivalent cumulative exposure between modified titration and standard dosing regimen.

The study’s primary endpoint was the proportion of participants with any occurrence of ARIA-E by week 24.

The results showed that the incidence of ARIA-E was 14% in patients receiving the modified titration compared with 24% for those receiving the standard dosing regimen, which is a 41% lower relative risk.

The largest ARIA-E reduction with the modified titration was seen in apolipoprotein E (APOE4) homozygotes, carriers of a known genetic risk factor for developing Alzheimer’s.

In these patients, 19% had ARIA-E on the modified titration compared to 57% on the standard dosing regimen, resulting in a 67% lower relative risk.

Patients on the modified titration of donanemab saw a reduction of amyloid plaque and P-tau217 comparable to patients receiving the standard dosing regimen.

As observed using amyloid PET at 24 weeks, amyloid plaque levels in patients on the modified titration of donanemab in TRAILBLAZER-ALZ 6 were reduced on average 67% from baseline compared to 69% for patients on the standard dosing regimen.

Price Action: LLY stock is up 1.06% at $905.09 at the last check on Tuesday.

Read Next:

• Trump Goes After Taiwan Semiconductor On Joe Rogan Podcast

Photo by Jonathan Weiss via Shutterstock