HK inno.N's new drug for gastroesophageal reflux disease, "K-CAB (ingredient name tegoprazan)," has begun the new drug approval process in the United States.
The company said on the 13th that Braintree Laboratories, a gastroenterology specialty firm under its U.S. partner Sebela Pharmaceuticals, submitted the new drug application (NDA) for K-CAB to the U.S. Food and Drug Administration (FDA) on the 9th (local time).
The application seeks simultaneous approval for three indications: non-erosive gastroesophageal reflux disease (NERD), treatment of erosive esophagitis (EE), and maintenance therapy after treatment of erosive esophagitis.
The basis for the filing is the phase 3 "TRIUMpH program" conducted in U.S. patients. More than 2,000 people participated, including 1,250 with erosive esophagitis and 800 with non-erosive gastroesophageal reflux disease. The trial was multicenter and double-blind.
In the erosive esophagitis study, tegoprazan was compared with the proton pump inhibitor lansoprazole to evaluate early healing effect and 24-week maintenance therapy. Tegoprazan showed efficacy at least equivalent to the existing therapy in the overall population for the week-8 healing rate and in maintenance, and demonstrated statistically significant superiority at both weeks 2 and 8 in the severe cohort (LA grades C and D).
In the non-erosive gastroesophageal reflux disease study, tegoprazan was compared with placebo for four weeks. Significant improvement over placebo was confirmed in key measures, including the proportion of days without 24-hour heartburn.
In both studies, the incidence of adverse events was under 3%, and most were mild and transient. The incidence of serious adverse events was similar to that of the control group.
Gastroesophageal reflux disease is a chronic condition in which stomach contents flow back into the esophagus, causing heartburn and acid regurgitation. The number of patients in the United States is estimated at about 65 million.
Unlike existing PPIs, K-CAB is a P-CAB class drug that directly blocks acid secretion without needing activation by gastric acid. It has signed technology transfer or finished drug export contracts with 56 countries worldwide, has approvals in 22 countries, and has launched in 19. Since its 2019 launch through last year, cumulative outpatient prescription sales in Korea have totaled 923.3 billion won.
Gwak Dal-won, CEO of HK inno.N, said, "As a global best-in-class product leading the world market, we will also actively pursue exports to Europe and development in Japan."