Shilpa Medicare successfully completes Phase 3 studies of SMLNUD07 – NorUDCA
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.
said, “We are very pleased with the successful Phase III trials outcome for this unique product addressing
the unmet need of patients suffering from NAFLD with a potential first line of treatment. This development
exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical
products that help improve the healthcare requirements of a large patient pool.”
NAFLD is the most common liver disease and it is estimated to affect about 25% of the population in World
(approx. 1.2 billion) and about 188 million people suffer from NAFLD in India. If NAFLD is not treated in a
timely manner, it is likely to turn into nonalcoholic steatohepatitis (NASH) which could have fatal implications
for the patient.
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