[News Space=Reporter seungwon lee] HK inno.N's new gastroesophageal reflux disease drug K-Cab (ingredient name: tegoprazan) has successfully completed phase 3 clinical trials in the United States. K-Cab met the primary and secondary endpoints in both erosive esophagitis (EE) and non-erosive gastroesophageal reflux disease (NERD) clinical trials. In particular, it demonstrated superiority over PPI in the treatment of erosive esophagitis in the second and eighth weeks.

This is the first major achievement in three years since HK inno.N transferred its technology to Sebela Pharmaceuticals in the US in 2021, and K-Cap's entry into the US market is expected to gain momentum in the future.

HK inno.N reported that its US partner Sebella announced the main results (top line) of two US phase 3 clinical trials 'TRIUMpH' evaluating tegoprazan (domestic product name: K-Cap) in patients with gastroesophageal reflux disease (GERD) on the 23rd (local time).

The US Phase 3 clinical trial, which recently announced the topline, was conducted on patients with erosive esophagitis (EE) and non-erosive gastroesophageal reflux disease (NERD). The US clinical trial was conducted by Braintree Laboratories, Inc., a gastrointestinal pharmaceutical subsidiary of Sebella, a US partner that signed a licensing agreement with HK inno.N in 2021.

In clinical trials for erosive esophagitis and non-erosive gastroesophageal reflux disease, tegoprazan met both primary and secondary endpoints.

In particular, in clinical trials of erosive esophagitis, statistical superiority over PPI (lansoprazole) was demonstrated in the 2- and 8-week cure rates in both the overall erosive esophagitis patient group and the moderate to severe esophagitis (LA grade C, D) patient group.

In clinical trials of non-erosive gastroesophageal reflux disease, tegoprazan was shown to provide complete symptomatic relief for both heartburn (at night and on heartburn-free days) and acid reflux.

Meanwhile, US partner Sebella plans to complete the ongoing Phase 3 clinical trial for 'maintenance therapy for erosive esophagitis' in addition to this clinical trial in the third quarter of this year. In the fourth quarter of 2025, it plans to submit a New Drug Application (NDA) to the US FDA including indications for erosive esophagitis and non-erosive gastroesophageal reflux disease. Sebella plans to submit the results of this TRIUMpH study to an authoritative academic journal and present them at a major gastroenterology conference.

Alan Cooke, President and CEO of Sebella Pharmaceuticals, said: “We are pleased that tegoprazan achieved both its primary and secondary endpoints in the erosive esophagitis and non-erosive GERD trials. In particular, we are encouraged by the superior cure rate observed in erosive esophagitis compared to lansoprazole at both two- and eight-week treatment periods.”

He continued, “Sebella has been dedicated to the field of gastroenterology and patients affected by gastrointestinal diseases for over 40 years. Tegoprazan is expected to provide a new treatment option for patients who do not respond sufficiently to existing PPI treatment.”

“The tegoprazan erosive esophagitis data suggest that the P-CAB class may be superior to PPIs and that tegoprazan may offer an advantage over other agents,” said Felice Schnoll-Sussman, M.D., professor of clinical medicine and director of the Jay Monahan Gastroenterological Center at Weill Cornell Medicine.

“Heartburn and acid reflux are the main symptoms of GERD, but so far, only heartburn symptom improvement has been discussed. This may be because previous drug treatment studies, unlike tegoprazan in the P-CAB class, failed to show a reduction in acid reflux symptoms,” said Dr. Prateek Sharma, a professor of medicine at the University of Kansas School of Medicine and current president of the American Society of Gastrointestinal Endoscopy.

HK inno.N CEO Kwak Dal-won said, “I am very honored that the new drug K-CAB developed in Korea has successfully completed phase 3 clinical trials in the U.S., the world’s largest pharmaceutical market.” He added, “Through close collaboration with Sebella and Braintree, we will do our best to ensure that tegoprazan becomes the new standard for gastroesophageal reflux disease treatment in the global market, including the U.S..”