메이저사이트

HK inno.N announced that its gastroesophageal reflux disease (GERD) treatment, K-CAB (ingredient: 메이저사이트), successfully met both primary and secondary endpoints in two U.S. Phase 3 clinical trials. Notably, 메이저사이트 demonstrated superiority over proton pump inhibitors (PPIs) in healing erosive esophagitis (EE) at both Week 2 and Week 8.

This milestone comes three years after HK inno.N licensed K-CAB to U.S.-based Sebela Pharmaceuticals in 2021 and is expected to accelerate the drug’s entry into the U.S. market.

The two U.S. Phase 3 trials—collectively known as TRIUMpH—evaluated 메이저사이트’s efficacy in patients with both EE and non-erosive reflux disease (NERD). Conducted by Braintree Laboratories, Sebela’s gastrointestinal specialty subsidiary, the studies assessed the following efficacy endpoints for the TRIUMpH-EE (Erosive Esophagitis) trial:

In the EE trial, 메이저사이트 showed statistically significant superiority over lansoprazole in healing rates, both among the overall EE population and patients with moderate-to-severe esophagitis (LA Grades C and D). In the NERD trial, 메이저사이트 achieved complete symptom relief, significantly improving heartburn—including nighttime symptoms—and acid regurgitation.

Sebela Pharmaceuticals is expected to complete an additional Phase 3 maintenance study for EE in the third quarter of 2025, with plans to submit a New Drug Application (NDA) to the U.S. FDA in the fourth quarter, covering indications for both EE and NERD. Sebela also intends to present the TRIUMpH trial results at major gastroenterology conferences and submit them for publication in a leading peer-reviewed journal.

Alan Cooke, President and CEO of Sebela Pharmaceuticals, commented, “We are pleased that 메이저사이트 achieved all primary and secondary endpoints in both EE and NERD trials. Particularly notable is its superior healing performance compared to lansoprazole at Weeks 2 and 8 in EE. We believe 메이저사이트 will offer a valuable new treatment option for patients inadequately controlled on existing PPI therapies.”

Dr. Felice Schnoll-Sussman, Professor of Clinical Medicine at Weill Cornell Medical College, added, “The EE data suggest that the P-CAB class may offer improved outcomes over PPIs, highlighting 메이저사이트’s clinical advantage.”

Dr. Prateek Sharma, Professor at the University of Kansas Medical Center and President of the American Society for Gastrointestinal Endoscopy (ASGE), stated, “While heartburn and acid regurgitation are hallmark GERD symptoms, past treatments mainly targeted heartburn. 메이저사이트 stands out by addressing both, likely due to its distinct mechanism as a P-CAB.”

HK inno.N CEO Dal-won Kwak said, “It is highly meaningful that K-CAB, a drug developed in Korea, has successfully completed Phase 3 trials in the world’s largest pharmaceutical market. We will continue working closely with Sebela and Braintree to establish 메이저사이트 as a new standard for GERD treatment globally.”

Meanwhile, in a U.S. Phase 1 clinical trial, 메이저사이트 showed no food effect and rapidly elevated gastric pH above 4 within 45 minutes of administration. This rapid onset positions 메이저사이트 as a differentiated treatment option for patients not adequately controlled by PPIs.

In the TRIUMpH studies, the incidence of individual adverse events was below 3%, with most being mild and transient. The serious adverse event rate was below 2%, with no significant differences between 메이저사이트, PPI, and placebo groups. Additionally, mean serum gastrin levels remained within the normal range (0–180 pg/mL) for both the 메이저사이트 and lansoprazole groups throughout the study period.