In short
BI 1584862 is an investigational chemical substance developed by Boehringer Ingelheim. It is being studied as a potential treatment for dry age-related macular degeneration, an eye disease. One completed Phase 1 trial in 14 healthy volunteers investigated how the drug behaves in the body when taken with itraconazole.
Key points
- BI 1584862 is an investigational medicine with no marketing authorisation.
- It is being developed for dry age-related macular degeneration, an eye disease.
- The substance is a phospholipid modulator taken as a film-coated tablet by mouth.
- A Phase 1 trial in 14 healthy volunteers has been completed.
- The trial measured how itraconazole affects the amount of BI 1584862 in the blood.
- BI 1584862 has reached Phase 2 development for dry age-related macular degeneration.
What is BI 1584862?
BI 1584862 is a chemically synthesised substance developed by Boehringer Ingelheim. It is an investigational medicine, meaning it has no marketing authorisation in the product records and is still being studied in clinical trials. The substance is also known by the alternative name BI-1584862. BI 1584862 is classified as a new molecular entity and belongs to the class of eye disorder therapies.
How does BI 1584862 work?
BI 1584862 is described as a phospholipid modulator. Phospholipids are fatty molecules that are important building blocks of cell membranes. Modulating phospholipids means the substance is designed to influence how these molecules behave in cells, which may be relevant to the disease process in the eye. The exact mechanism in dry age-related macular degeneration is still being investigated.
Which conditions is it studied for?
- Dry age-related macular degeneration — a common eye disease that affects the central part of the retina, called the macula, leading to gradual loss of central vision. BI 1584862 has reached Phase 2 development for this condition.
- Healthy volunteer trial — a Phase 1 study in healthy men was completed to investigate how the drug behaves in the body.
How is BI 1584862 given?
BI 1584862 is given as a film-coated tablet for oral use, meaning it is taken by mouth. In the completed Phase 1 trial, a 20 mg dose of BI 1584862 was used.
What do the clinical trials show?
The clinical trial registry contains one completed Phase 1 trial of BI 1584862. This trial enrolled 14 healthy men and investigated the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of BI 1584862. Pharmacokinetics describes how the body absorbs, distributes, breaks down and removes a drug.
The main measurements in this trial were AUC0-∞ and Cmax. AUC0-∞ is the area under the concentration-time curve, which shows the total exposure to the drug in the blood over time. Cmax is the maximum concentration of the drug reached in the blood. These measurements help researchers understand whether itraconazole changes how much BI 1584862 stays in the body.
Itraconazole, sold under the name Sempera Liquid, was given at a dose of 200 mg by mouth in this trial as the comparison medicine. The trial status is completed.