Shilpa Medicare Ltd. announced the successful completion of early clinical development and ongoing Phase 3 clinical trial of its newly developed drug "SML-007", for the treatment of non-alcoholic fatty liver disease (NAFLD). The recruitment of NAFLD patients (Fibrosis stage F2 & F3) for Phase 3 trial has been completed across multiple centres. Phase 3 clinical study dosing is expected to be completed by end of first quarter and study is likely to be concluded by end of second quarter of current fiscal year.

SML 007 is an orally administered drug with significant benefits over the currently available bile acid family of drugs used for the treatment of liver diseases. These additional benefits are reshaping bile acid synthesis, thereby promoting the restoration of liver FXR signalling and also action through adiponectin receptor pathway. SML-007 has demonstrated superior anti-inflammatory and antifibrotic effect in pre-clinical studies.

SML-007 demonstrates improvement of fibrosis. Non-alcoholic fatty liver disease ("NAFLD") is the most common cause of chronic liver disease affecting about twenty five% of the global population. About fourteen% of persons with NAFLD have a more aggressive form known as non-alcoholic steatohepatitis (NASH), which can progress to advanced liver fibrosis, cirrhosis, or liver cancer.