Shilpa Medicare completes phase-3 trial of novel therapy against nonalcoholic fatty liver disease, shares gain, ET HealthWorld

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Shilpa Medicare completes phase-3 trial of novel therapy against nonalcoholic fatty liver ********, shares gain, ET HealthWorld

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New Delhi: Shares of Shilpa Medicare rose 6.40 per cent 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 ******** (NAFLD).

The multicentric, placebo controlled double blinded study trial was conducted on a total 165 nonalcoholic fatty liver ******** (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 **** 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 properties and reduction in fibrosis.

“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,” said Vishnukant Bhutada, managing director Shilpa Medicare.

NAFLD is the most common liver ******** and it is estimated to affect about 25% of the population in World 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.

• Published On Aug 26, 2024 at 04:10 PM IST

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