Hutchison China MediTech Limited, generally called Chi-Med, recently announced the initiation of its first-in-human Phase 1 clinical trial of HMPL-689, a drug the company aims to evaluate in B-cell malignancies.
The trial, planned to run for a year, will be held in Australia and managed by Hutchison MediPharma Limited (HMP) – Chi-Meds drug research and development subsidiary – will focus on drug development in oncology and autoimmune diseases. The study will evaluate the safety and tolerability of the drug in adult, healthy volunteers, and will not be tested in patients until future trials.
The study will also explore the pharmacokinetic properties – the specifics of how a drug is absorbed, distributed, metabolized, and excreted from the body. The drug will be administered in a randomized, double-blind, and placebo-controlled fashion, with seven escalating doses ranging from 1 to 30 mg of the drug, provided to maintain safety of the volunteers. For every three volunteers who receive the drug, one will be administered a placebo. The first drug dose was administered on April 7, 2016.
HMPL-689 is a small molecule blocker of the delta isoform of the phosphatidylinositol-3-kinase (PI3Kδ). The factor is a key constituent of a pathway involving signaling by B-cell receptors. Immune B-cells are an important part of the body’s immune system, but also are the target of numerous disease mechanisms. The drug, therefore, has the potential to be used in a wide array of diseases in addition to cancer, such as autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, and allergies – areas where immune therapy has already improved treatment results.
If the Phase 1 trial is successful, HMP will continue to evaluate the drug in B-cell malignancies such as lymphoma and leukemia. Treatments targeting B-cells, such as monoclonal antibodies and small molecules, have already proven successful in lymphoma. PI3Kδ is, however, a new target showing promise in improving treatment of both cancer and immune-related diseases.
The drug has shown promising results in preclinical studies, where it was found superior to other drugs in the same class, with better potency and selectivity against PI3Kδ. Preclinical research also supports the efficacy and safety of the compound in animal models.