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Chi-Med Announces Positive Phase II Proof-of-Concept Data for,HMPL-004 in Ulcerative Colitis

f the Mesalazine group.

Chi-Med’s extensive preclinical work with HMPL-004 has shown that HMPL-004 acts on multiple cellular targets in the inflammatory signal transduction pathways resulting in suppressed inflammation cytokine expression including TNF-?, IL-1? and IL-6. HMPL-004 was demonstrated to inhibit TNF-? and IL-1? production in cell-based assays and is also able to inhibit NF-kB activation. The novel mechanism of action of HMPL-004, compared to current conventional therapies, including Mesalazine, allows it to access a unique patient population. Moreover, Mesalazine is well known to be effective in about 60% of the patients it is used in and patients’ resistance over long-term use is common. The Directors believe that today’s result is highly important because it shows that HMPL-004 has a similar margin of effect yet offers a different mechanism of action and therefore provides a direct alternative to the current best standard of care. If ultimately approved, HMPL-004 will provide significant commercial value to Chi-Med.

HMPL-004 is an orally active, proprietary botanical product that acts on multiple targets in the pathogenesis of inflammation. It is a compound extracted from a Chinese herb that has extensive history of use in China and South East Asia against respiratory infections and inflammation. This documentation enabled Chi-Med to accelerate the clinical process for HMPL-004 by by-passing Phase I trials, based on the FDA’s 2004 guidance on botanical drug products. HMPL-004 is currently also in Phase II trial in the US for the treatment of Crohn’s Disease.






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