Shilpa Medicare jumped 6.40% to Rs 741.90 after the company informed that it has successfully completed phase-3 clinical studies of its product SMLNUD07 - Nor Ursodeoxycholic Acid (NorUDCA) tablets.
NorUDCA is expected to revolutionise the treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD). 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.
The company said that the trial was a multicentric, placebo controlled double blinded study conducted on total 165 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 1,500 mg per day for the duration of 24 weeks, it added.
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 treatments effect by capturing multiple relevant outcomes, the company stated in the press release.
Further, Shilpa Medicare plans to submit these Phase 3 clinical trial findings at the earliest to the Central Drugs Standard Control Organisation(CDSCO), India for seeking marketing authorization in India, said the company.
Vishnukant Bhutada, managing director, Shilpa Medicare said, This development exemplifies Shilpas constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.
The counter hit a 52-week high of Rs 778.20 in todays intraday session.
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