LY3303560 is an antibody that Eli Lilly has developed to counter the harmful tau protein associated with Alzheimer’s disease.

How LY3303560 works

Alzheimer’s is a neurodegenerative disorder characterized by a slow worsening of memory and cognitive function. The symptoms are caused by the death of nerve cells in the brain. Tau is one of two proteins whose build-up in nerve cells drives the progression of Alzheimer’s.

LY3303560 is an antibody that Eli Lilly designed to bind to and neutralize tau clumps, slowing or stopping the worsening of Alzheimer’s.

LY3303560 in clinical trials

Eli Lilly conducted a study in rats and primates on whether the body is able to process LY3303560 favorably and whether the antibody could bind with tau. The study, published in July 2017 in The Journal of the Alzheimer’s Association, showed that both types of animals processed it favorably and that the antibody had an affinity for tau.

Based on these results, Eli Lilly started a Phase 1 clinical trial (NCT02754830) of LY3303560 in up to 110 Alzheimer’s patients and healthy volunteers. Some of the participants had mild cognitive impairment. Others had mild to moderate cases of Alzheimer’s.

The study’s main goals were to assess the therapy’s safety, and patients’ ability to tolerate it. Researchers administered it as a single dose, either by injection or IV.

The trial is continuing in California and Maryland but no longer recruiting participants.

Eli Lilly also continues to recruit up to 24 participants with mild cognitive impairment or Alzheimer’s for another Phase 1 trial (NCT03019536). The goal is to assess the safety of repeated doses of LY3303560 given by injection for 25 weeks.

A key measure will be the number of participants whose treatment leads to one or more serious adverse events. Secondary outcomes include evaluating how the body processes the therapy.

Researchers are enrolling patients in the U.S., Japan, and the U.K. The trial is expected to be completed by May 2019.

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