Daewoong "Ursa Shows Liver Function Improvement in Phase 4 Trial"
Presented at the Asia-Pacific Digestive Disease Week
Ursa has once again proven its liver function improvement effects through clinical trials.
Daewoong Pharmaceutical announced on the 26th that it presented the results of Ursa’s Phase 4 clinical trial for patients with chronic liver disease at the Asia-Pacific Digestive Disease Week, the largest international digestive conference in Asia, held in Bali, Indonesia from the 21st to the 24th.
This Phase 4 study was conducted to secure the latest clinical evidence for Ursa. A 2020 meta-analysis of foreign literature indirectly confirmed liver function improvement after taking Urso-deoxycholic acid (UDCA), the active ingredient of Ursa, but the latest clinical evidence was limited. This study directly reaffirmed Ursa's (100mg) consistent liver function improvement effects, which strengthened the latest clinical evidence, according to Daewoong Pharmaceutical.
According to the study, Ursa reduced both ALT (Alanine Aminotransferase) levels and serum fibrosis marker levels, key indicators for liver disease. Both liver function and liver fibrosis improvement effects were observed in patients with chronic liver disease. ALT is a liver-specific enzyme found mainly in liver cells, and when liver cells are damaged, ALT levels rise, making it an important marker for assessing liver cell-related diseases and liver conditions. Serum fibrosis markers are used to assess liver fibrosis.
The study, conducted at 20 hospitals, aimed to evaluate the efficacy and safety of Ursa. The target participants were patients whose ALT levels exceeded normal levels but were within 5 times the upper normal limit. A total of 262 patients were enrolled, and they were divided into two groups: the Ursa (100mg) group (132 patients) and the control group (130 patients), with both groups receiving either Ursa or a placebo three times a day for eight weeks.
The results showed that Ursa was superior to the placebo group in reducing and normalizing ALT levels and improving liver fibrosis. Comparing the mean change in ALT levels at 8 weeks, the control group showed a decrease of 5.51 U/L, while the Ursa group showed a decrease of 14.70 U/L, which is approximately 2.7 times greater than the control group. Safety assessments showed no statistically significant differences in adverse events (AEs) or adverse drug reactions (ADRs) between the Ursa and control groups, and no serious adverse events (SAEs) or serious drug adverse reactions (SADRs) were reported.
Professor Jae-Young Chang, the clinical trial coordinator and a gastroenterologist at Soonchunhyang University Hospital, stated, "Through this study, we were able to confirm not only the liver function improvement effects of Ursa for chronic liver disease patients but also the effects on liver fibrosis. Based on this latest clinical evidence, Ursa is expected to have a positive impact on the treatment of chronic liver disease patients and will be an innovative treatment option."
Daewoong Pharmaceutical CEO Chang-Jae Lee commented, "Ursa, which has a long history, has once again enhanced its reputation as the leading liver medication in Korea by securing the latest clinical evidence in chronic liver disease patients."