The shares of Shilpa Medicare Ltd skyrocketed 11% on 26 August following the company’s announcement of a positive result in Phase 3 trials for SMLNUD07, a medication known as NorUDCA. This drug is intended to treat those who suffer from nonalcoholic fatty liver disease (NAFLD).
According to Shilpa Medicare, nonalcoholic fatty liver disease (NAFLD) is the most prevalent liver illness and affects around 1.2 billion individuals worldwide or over 188 million people in India.
The business revealed the results of a medication trial and stated that if nonalcoholic steatohepatitis (NASH) is not treated promptly, it can lead to deadly consequences for the patient.
The tablets are expected to “revolutionise the treatment of patients suffering from NAFLD,” said Shilpa Medicare in a regulatory filing. A multicentric, double-blind, placebo-controlled trial with 165 NAFLD patients was carried out throughout India.
The company added, “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.”
Liver fibrosis significantly decreased as a result of the trial, at least one stage. Furthermore, Shilpa Medicare was informed that there was a decrease in the formation of fat in the liver.
“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.
In order to get marketing authorisation in India, Shilpa Medicare intends to submit the results of these Phase 3 clinical trials as soon as possible to the Central Drugs Standard Control Organization (CDSCO), India.
At 11:12 am, the shares of Shilpa Medicare were trading 6.21% higher at Rs 741.20 on NSE.
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