BI 1815368

What is BI 1815368?

BI 1815368 is a chemically synthesised substance being developed as an oral medicine. It is an investigational drug, meaning it has no marketing authorisation and is only available within clinical trials.^[2][1] The product records list Boehringer Ingelheim International as the supplier. The substance is registered in the CTIS under the therapeutic area of eye diseases (C11).^[2]

How does BI 1815368 work?

The available registry records do not describe the mechanism of action of BI 1815368. The Phase 2 trial in diabetic macular edema is designed to evaluate a dose-response relationship, which means researchers want to see how different doses affect vision outcomes.^[2] The Phase 1 trial measured how much of the drug stays in the blood over time (area under the concentration-time curve, AUC) and the maximum concentration reached (Cmax), which are standard measures of how a drug is absorbed and processed by the body.^[1]

Which conditions is BI 1815368 studied for?

• Centre-involved diabetic macular edema (CI-DME) — a complication of diabetes in which fluid builds up in the central part of the retina, the light-sensitive layer at the back of the eye, causing vision loss. The Phase 2 trial includes people with varying levels of vision impairment.^[2]
• Healthy volunteers — the Phase 1 trial was conducted in healthy men to study how the body handles the drug when given alone and together with another medicine.^[1]

How is BI 1815368 given?

BI 1815368 is given by mouth as a film-coated tablet.^[2][1] In the completed Phase 1 trial, a single oral dose of 25 mg was used to study drug interactions.^[1] The dose for the Phase 2 trial is not stated in the registry record.^[2]

What do the clinical trials show?

Two trials of BI 1815368 are registered. The Phase 2 trial in centre-involved diabetic macular edema is authorised but not yet reporting results. It plans to enrol 300 participants and will compare different doses of BI 1815368 against placebo.^[2] The Phase 1 trial in 14 healthy men has been completed. It investigated how itraconazole, an antifungal medicine, affects the amount of BI 1815368 in the blood.^[1]

What are the trials measuring?

The Phase 2 trial measures whether participants gain at least 10 letters on a standard eye chart test (ETDRS letters) in the study eye at Week 48 compared with the start of the trial.^[2] The Phase 1 trial measured the area under the concentration-time curve (AUC0-∞) and the maximum plasma concentration (Cmax) of BI 1815368.^[1]

Who can take part in these trials?

The Phase 2 trial enrols men and women with centre-involved diabetic macular edema and varying levels of vision impairment due to the condition.^[2] The Phase 1 trial enrolled healthy men only.^[1]

What side effects are known?

The registry records do not report side effects for BI 1815368. No supplementary safety information was provided.