HMPL-004, an extract of Andrographis paniculata, has an efficacy similar to mesalazine for the treatment of ulcerative colitis with a good safety profile, reports a new study from China.

“The herb has a well known history for treating various common inflammatory and infectious diseases in China and many other countries,” says Tom Tang, corresponding author of the study. “We believe it has great potential for the treatment of IBD.”

Prior to this study, the group performed cell-based anti-inflammatory screening assays and found that HMPL-004 targets NFκB activation, leading to the inhibition of production of many inflammatory cytokines, such as TNF, IL-1β and IL-6. Subsequent research in animal models of colitis showed that this herbal preparation was efficacious. Tang and colleagues, therefore, designed this proof-of-concept clinical trial of HMPL-004 for the treatment of active, mild-to-moderate ulcerative colitis; 125 patients at five centers were included.

Comparing HMPL-004 to the common first-line induction therapy mesalazine, no significant difference was found between the drugs with regard to efficacy of therapy (as determined by symptom scores), clinical efficacy and histology. The safety profile of HMPL-004 was good.

“We have accumulated a lot of valuable evidence from this study and it is the foundation of our succeeding clinical studies,” says Tang. “HPML-004 may become a new approach for the treatment of active IBD.” A phase III global trial will begin this year.