Shilpa Medicare completes phase 3 studies of Nor Ursodeoxycholic Acid (NorUDCA) tablets; stock up over 5%.

Shilpa Medicare reported that the trial was a multicentric, placebo-controlled, and double-blinded study conducted on a total of 165 NAFLD patients across India. Further, the company stated that the study found no serious adverse event—the phase 3 treatment comprised a 1500 milligram (mg) dose per day for 24 weeks.

At the end of the study, the treatment resulted in a decrease in liver fibrosis by at least one stage. Moreover, the treatment also resulted in the reduction of fat accumulation in the liver. The company made use of Fibroscan, a USFDA-approved imaging technique to measure the decrease in liver fibrosis. The study tracked the decline in fat accumulation through the CAP scoring technique. Additionally, the phase 3 trials saw normalisation of Alanine Aminotransferase (ALT).

The company stated that NorUDCA could become the new standard in restoring liver function in NAFLD patients. Shilpa Medicare added that NorUDCA has several advantages including better choleretic effect, resistance to amidation, anti-inflammatory properties, and a reduction in fibrosis.

Vishnukant Bhutada, managing director at Shilpa Medicare, said that the company’s product is expected to be a potential first line of treatment for patients and is in line with the company’s efforts towards introducing novel medical solutions.

“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,” he said.

The company stated that NAFLD is the most common liver disease and affects approximately 1.2 billion people with around 188 million patients in India.

Shares of the company have risen by nearly 130% since the beginning of the year. The stock has gained over 101% in the past year.