Shares of Shilpa Medicare rose 6.40% on BSE on Monday, and were trading at Rs 741.90 at 12 noon, on company's announcement of successfully completion of phase-3 clinical studies of its novel product SMLNUD07 - Nor Ursodeoxycholic Acid ( NorUDCA ) tablets for treatment of patients suffering from Nonalcoholic Fatty Liver Disease ( NAFLD ).
The multicentric, placebo controlled double blinded study trial was conducted on a total 165 nonalcoholic fatty liver disease (NAFLD) patients across India. There were no serious adverse events 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 the liver. Also a significant normalization of Alanine Aminotransferase (ALT) was conclusively demonstrated in this study. "These results indicate that NorUDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients," Shilpa Medicare said in a statement to stock exchanges.
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. NorUDCA 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 pro.