Shilpa Medicare has recently announced that it successfully completed phase-3 clinical studies on its novel productSMLNUD07 – Nor Ursodeoxycholic Acid (NorUDCA) tablets, which is likely to change the treatment of Nonalcoholic Fatty Liver Disease (NAFLD).
In the exchange filing, the company shared, “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 statement further reads, “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 suggest that NorUDCA might become the new standard of care for restoring liver function in NAFLD patients. Shilpa Medicare Ltd intends to submit the findings of the Phase 3 clinical trial to the CDSCO, India, as soon as possible to get marketing authorization in India.