 |
|
Shilpa Medicare, an Indian pharmaceutical company, witnessed a significant surge in its share price on Monday following the successful completion of Phase 3 clinical trials for its novel drug, NorUDCA, intended to treat Nonalcoholic Fatty Liver Disease (NAFLD). The company's stock rallied over 11 percent, reaching an all-time high of Rs 778.20, driven by the positive results from the trials. This surge signifies investor confidence in the potential of NorUDCA to revolutionize the treatment of NAFLD, a growing health concern globally.
NorUDCA, also known as SMLNUD07, is a novel form of ursodeoxycholic acid (UDCA) that has been designed to offer enhanced benefits for NAFLD patients. The Phase 3 trials were conducted across India involving 165 patients with NAFLD. The trials were meticulously designed as multicentric, placebo-controlled, double-blinded studies, ensuring robust scientific rigor. The results demonstrated that NorUDCA was well-tolerated by patients at a dosage of 1,500 mg per day for a period of 24 weeks, with no serious adverse effects reported.
The most significant finding of the trial was the observed improvement in liver fibrosis among the patients. NorUDCA treatment resulted in at least one stage decrease in liver fibrosis, indicating its ability to effectively address the underlying pathology of NAFLD. Additionally, the drug demonstrated a significant reduction in fat accumulation within the liver, further underscoring its positive impact on liver health. These promising results have fueled optimism within the company and the investor community, suggesting a potential game-changer in the treatment of NAFLD.
Following the successful completion of the Phase 3 trials, Shilpa Medicare announced its plans to submit the findings to the Central Drugs Standard Control Organisation (CDSCO) in India for obtaining marketing authorization. This step marks a crucial milestone in bringing NorUDCA to market and making it available to patients in India. The company believes that NorUDCA, with its unique advantages over conventional UDCA, including enhanced choleretic effects, resistance to amidation, anti-inflammatory properties, and fibrosis reduction, is poised to become a first-in-class treatment option for NAFLD in the country.
The impressive stock performance of Shilpa Medicare, gaining nearly 233 percent in the past three months and an astounding 412.50 percent year-to-date, is a testament to the market's confidence in the company's future prospects. The successful NorUDCA trials have not only solidified Shilpa Medicare's position as a leader in the pharmaceutical sector but also ignited anticipation for its potential impact on the lives of countless individuals suffering from NAFLD.
The growing prevalence of NAFLD globally underscores the urgency for effective treatment options. As a chronic liver disease that can progress to cirrhosis, liver failure, and even liver cancer, NAFLD poses a significant public health concern. The emergence of NorUDCA with its promising results in clinical trials offers hope for patients and a potential solution for healthcare systems burdened by the rising incidence of NAFLD.
Source: Shilpa Medicare hits fresh high on successful trial of liver fibrosis drug