GC Wellbeing announced on June 16 that it has secured topline results demonstrating that its chronic liver disease treatment, Laennec Injection, successfully met the primary endpoint in a Phase 3 clinical trial evaluating a high-dose intravenous drip regimen.
Intravenous drip administration delivers a therapeutic agent slowly over a set period, similar to a standard IV fluid infusion. According to the company, the existing subcutaneous and intramuscular injection methods can be inconvenient because high-dose treatment requires multiple separate injections. If the intravenous regimen receives regulatory approval, Laennec Injection could be administered as a single IV infusion, greatly simplifying high-dose dosing protocols for patients and healthcare providers.
The Phase 3 trial, which commenced in April 2024 across 18 medical institutions in South Korea, enrolled 226 patients diagnosed with chronic liver disease. The study compared a high-dose intravenous drip group against a subcutaneous administration group to evaluate both efficacy in improving liver function and overall safety.
The clinical data revealed that the high-dose intravenous drip group achieved a statistically significant improvement compared to the subcutaneous group in the change of alanine aminotransferase (ALT) levels at six weeks, which served as the primary endpoint. ALT is a critical liver enzyme whose blood concentration spikes when liver cells suffer damage, making it a standard clinical indicator for assessing liver function recovery.
Company officials noted that Laennec Injection is projected to surpass cumulative sales of 100 million doses this year since its initial market launch in 2005. The addition of the expanded intravenous administration method is forecasted to generate more than 20 billion won in additional annual revenue moving forward.
Jung Si-young, head of R&D at GC Wellbeing, stated, "The success of this Phase 3 trial scientifically validates the clinical value of administering Laennec Injection via intravenous drip." Jung added, "Based on the robust data secured, we plan to swiftly proceed with an application for a product label change with the Ministry of Food and Drug Safety within the year."
