HK Inno.N's treatment for gastroesophageal reflux disease, K-Cab (ingredient name tegoprazan), has demonstrated effectiveness in improving symptoms for patients with non-erosive gastroesophageal reflux disease in a Phase 3 clinical trial in the United States. As the company prepares to enter the U.S. market, it has secured clinical evidence to support the expansion of its indications, raising expectations for approval from the U.S. Food and Drug Administration (FDA).
On October 12, HK Inno.N announced that its U.S. partner, Sebela Pharmaceuticals, will present the Phase 3 clinical trial results for K-Cab at the American College of Gastroenterology (ACG) Annual Scientific Meeting 2026, taking place from October 9 to 14 in Tennessee. The results will be presented on October 14 by Professor Roni Paz from Case Western Reserve University.
Non-erosive gastroesophageal reflux disease is characterized by heartburn or acid reflux symptoms without visible damage to the esophageal mucosa during endoscopic examination.
The trial involved 783 adult patients in the U.S., who received either 50 mg or 100 mg of tegoprazan or a placebo once daily for four weeks, followed by a 20-week extension period.
During the initial four weeks, the percentage of days without 24-hour heartburn was 17.3% in the placebo group, 26.2% in the 50 mg group, and 30.1% in the 100 mg group. The percentage of nights without heartburn was also higher in the treatment groups, with 36.1% for the 50 mg group and 39.9% for the 100 mg group compared to 27.0% in the placebo group. Both doses met primary and secondary endpoints, showing statistically significant differences compared to the placebo.
In a composite measure evaluating days without both heartburn and acid reflux, the 50 mg group showed a 60% improvement compared to placebo, while the 100 mg group showed a 76% improvement. The company noted that the symptom improvement effects continued throughout the 20-week extension period.
At the conference, a reanalysis of the Phase 3 data for K-Cab in erosive esophagitis will also be presented. According to results applying the international diagnostic criteria of the Lyon Consensus 2.0, the healing rate for esophagitis at two weeks of treatment was 75.4% in the tegoprazan group, compared to 60.7% in the lansoprazole group. This study received the President's Award from the American College of Gastroenterology.
A representative from HK Inno.N stated, "It is significant that we shared large-scale U.S. patient data at an international conference," adding, "We will work with our partner to establish K-Cab's presence in the world's largest pharmaceutical market."
Earlier this year, in January, Sebela submitted a new drug application for K-Cab to the FDA. They are proceeding with follow-up procedures aiming for a local launch in early next year, and if U.S. approval is granted, HK Inno.N will receive a milestone payment. Following the product launch, royalty revenue can also be anticipated based on sales performance.
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.