Shilpa Medicare successfully completes Phase 3 studies of SMLNUD07 - NorUDCA

The trial resulted in significant, at least one stage, decrease in liver fibrosis. Additionally, there was a significant reduction in fat accumulation in liver. The decrease in fibrosis was measured using the “Fibroscan” technique which is the USFDA approved imaging technique for assessment of liver fibrosis. The decrease in fat accumulation was evaluated through the CAP scoring technique. Significant normalization of Alanine Aminotransferase (ALT) was conclusively demonstrated in this study. This approach provides a more holistic view of the treatment’s effect by capturing multiple relevant outcomes. These results indicate that NorUDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients.

Shilpa Medicare Ltd plans to submit these Phase 3 clinical trial findings at the earliest to the CDSCO, India for seeking marketing authorization in India. Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India and has significant advantages over UDCA like enhanced choleretic effect, resistance to amidation, anti-inflammatory properties and reduction in fibrosis, said the Company.

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