Shilpa Medicare stock surges 8% on Phase 3 clinical trial success for NAFLD drug

Shilpa Medicare stock has risen 132 percent so far this year, more than doubling investors' money.

Shilpa Medicare shares surged by 8 percent following the company’s announcement of a successful outcome in Phase 3 studies for SMLNUD07, a drug known as NorUDCA. This medication is designed to treat patients with Nonalcoholic Fatty Liver Disease (NAFLD).

The positive results from these advanced clinical trials boosted investor confidence, leading to a notable increase in the company's stock price.

NAFLD is the most common liver disease and it is estimated to affect about 25 percent of the global population (approximately 1.2 billion), with about 188 million people suffering from NAFLD in India, noted Shilpa Medicare.

If NAFLD is not treated in a timely manner, it is likely to progress to nonalcoholic steatohepatitis (NASH), which could have fatal implications for the patient, the company said while sharing drug trial results.

Follow our market blog to catch all the live action

The tablets are expected to "revolutionise the treatment of patients suffering from NAFLD," said Shilpa Medicare in a regulatory filing. The trial was a multicentric, placebo-controlled, double-blinded study conducted on 165 NAFLD patients across India.

"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," the company added.

The trial resulted in a significant, at least one-stage, decrease in liver fibrosis. Additionally, there was a reduction in fat accumulation in the liver, informed Shilpa Medicare. "The results indicate that NorUDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients," the company said.

Shilpa Medicare plans to submit these Phase 3 clinical trial findings at the earliest to the Central Drugs Standard Control Organisation(CDSCO), India to seek marketing authorization in India.

At 10:18 am, Shilpa Medicare shares were trading 6.7 percent higher at Rs 744.45 on the National Stock Exchange (NSE). The company's stock has risen 132 percent so far this year, more than doubling investors' money. In the past 12 months, the stock has risen 103 percent, beating Nifty's returns of 29 percent during this period.

Disclaimer: The views and investment tips expressed by investment experts on Moneycontrol.com are their own and not those of the website or its management. Moneycontrol.com advises users to check with certified experts before taking any investment decisions.