Shilpa Medicare hits fresh high on successful trial of liver fibrosis drug

Shares of Shilpa Medicare rallied more than 11 per cent in Monday's intra-day trading session to hit an all-time high of Rs 778.20, after the company announced the successful completion of the Phase 3 trials of its non-alcoholic fatty liver disease (NADLD) drug that it calls NorUDCA.

The company, in an exchange filing, said, "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)".

Around noon, shares of Shilpa Medicare were trading at Rs 733.15, up by nearly Rs 36, or 5.15 per cent on the BSE. In contrast, the 30-stock BSE Sensex was trading at 81,714 levels, up 0.77 per cent.

 

The company's stock had touched a fresh all-time high of Rs 778.20 earlier in the trading session, while its 52-week low stood at Rs 296.45.

Shilpa Medicare had conducted a multicentric, placebo controlled double blinded study on a total of 165 Nonalcoholic fatty liver disease (NAFLD) patients across India.

Shilpa Medicare disclosed that no serious adverse effects were reported during the phase 3 study and the treatment was well tolerated at the dose of 1,500 mg per day for the duration of 24 weeks.

The company said that the drug resulted in at least one stage decrease in liver fibrosis of patients enrolled in the trail. Additionally, there was a significant reduction in fat accumulation in the liver of patients.

Following the positive results from the trials, the company said that it "plans to submit these Phase 3 clinical trial findings at the earliest to the CDSCO, India for seeking marketing authorization in India."

The company claims that NorUDCA is likely to be a first-in-class treatment option for NAFLD in India, it provides significant advantages over UDCA like enhanced choleretic effect, resistance to amidation, anti-inflammatory properties and reduction in fibrosis.

Moreover, the company has gained nearly 233 per cent in the past three months, compared to a gain of 8.35 per cent for the BSE Sensex.

During the year-to-date period, the company's stock has appreciated by 412.50 per cent, compared to the 13.06 per cent gain in the BSE Sensex.