Shilpa Medicare successfully completes Phase 3 studies of SMLNUD07 - NorUDCA
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.
Karnataka: Shilpa Medicare has successfully completed phase-3 clinical studies of its novel product SMLNUD07 - Nor Ursodeoxycholic Acid (NorUDCA) tablets that is expected to revolutionise the treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD).
This trial was a multicentric, placebo controlled double blinded study conducted on total 165 Nonalcoholic fatty liver disease (NAFLD) patients across India – a significant statistically powered number of patients leading to better reliability of data and results. No serious adverse events were reported in this phase 3 study and the treatment was well tolerated at the dose of 1500 mg per day for the duration of 24 weeks.
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.
Read also: Shilpa Medicare successfully completes Phase 1 clinical trial for Recombinant Human Albumin 20%
