In short
LB-208 is an investigational chemical substance being studied as an oral treatment for adults with relapsed or refractory acute myeloid leukaemia (AML) and higher-risk myelodysplastic syndrome (MDS). A Phase 1/2 trial authorised in the EU is currently testing its safety and tolerability in 60 participants. The study aims to find the maximum tolerated dose and a recommended Phase 2 dose.
Key points
- LB-208 is an investigational chemical substance with no marketing authorisation.
- It is being studied in relapsed or refractory AML and higher-risk MDS.
- The authorised trial is a Phase 1/2 study in 60 adults.
- LB-208 is given as a hard capsule taken orally.
- The main goal is to assess safety and tolerability, including dose-limiting toxicity.
- The trial also aims to determine the maximum tolerated dose and a recommended Phase 2 dose.
What is LB-208?
LB-208 is a chemically synthesised substance being developed as a potential medicine for blood cancers. It is classified in the registry under neoplasms, the disease area covering cancers and related conditions. LB-208 has no marketing authorisation in the product records, meaning it is still an investigational substance and not yet approved as a medicine. The product is supplied by Leukos Biotech, S.L.
How does LB-208 work?
The registry data provided does not describe the mechanism of action of LB-208. No information about its molecular target or how it affects cancer cells is available in the sources for this page.
Which conditions is LB-208 being studied for?
- Relapsed or refractory acute myeloid leukaemia (AML) — a blood cancer where the disease has come back after treatment or has not responded to previous therapy.
- Higher-risk myelodysplastic syndrome (MDS) — a group of bone marrow disorders with an increased risk of developing into AML, where the disease has returned or not responded to treatment.
How is LB-208 given?
LB-208 is given as a hard capsule taken by mouth (oral use). The trial administers the drug continuously as a single agent.
What do the clinical trials show?
One Phase 1/2 trial is authorised in the EU, testing LB-208 in 60 adults with relapsed or refractory AML or higher-risk MDS. The study is interventional and is currently authorised.
The primary outcome measures safety and toxicity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This includes the rate of dose-limiting toxicity (DLT), which is the highest dose at which side effects remain acceptable, as well as adverse events, serious adverse events, and adverse events leading to discontinuation.
The trial also aims to determine the maximum tolerated dose (MTD) — the highest dose that can be given without unacceptable side effects — and a recommended Phase 2 dose of LB-208.
What side effects are known?
No information about specific side effects of LB-208 is available in the sources for this page. The authorised trial is designed to measure safety and toxicity, including adverse events and serious adverse events, but results have not been reported in the registry data.