HK Innoen Submits New Drug Application for K-CAB to FDA

Aiming for Approval of Three Indications Including Erosive Esophagitis
"U.S. Approval Expected in January 2027"

HK Innoen announced on January 13 that Braintree, a subsidiary of its U.S. partner company Sebela Pharmaceuticals, submitted a New Drug Application (NDA) for "K-CAB" (active ingredient: tegoprazan) to the U.S. Food and Drug Administration (FDA) on January 9 (local time).

HK Innoen Esophageal Reflux Disease New Drug K-CAB. HK Innoen

This NDA aims for simultaneous approval for three indications: treatment of non-erosive reflux disease (NERD), treatment of erosive esophagitis (EE), and maintenance therapy after treatment of erosive esophagitis.

The NDA submission was based on clinical data from the Phase 3 "TRIUMpH program," which involved more than 2,000 patients in the United States. According to HK Innoen, tegoprazan, a potassium-competitive acid blocker (P-CAB), demonstrated clinical superiority over existing proton pump inhibitor (PPI) drugs across various evaluation criteria.

Patients with non-erosive reflux disease who took tegoprazan showed a significantly higher proportion of days without heartburn over 24 hours compared to the placebo group. The proportion of days without nighttime heartburn and acid reflux symptoms was also higher than in the placebo group.

Across all patient groups, from mild to severe, tegoprazan demonstrated superior therapeutic effects compared to the existing PPI drug "lansoprazole." Statistically significant results were observed at both the two-week and eight-week treatment points.

In the 24-week maintenance therapy following healing of erosive esophagitis, patients taking tegoprazan maintained a higher rate of healing compared to those taking PPI drugs. Sebela Pharmaceuticals plans to present the full results of the TRIUMpH program at relevant academic conferences in the future.

Kwark Dalwon, CEO of HK Innoen, stated, "We are pleased to be able to proceed with the new drug approval process in the United States based on excellent clinical trial results," adding, "We will also actively pursue exports to Europe and development in Japan." Alan Cook, CEO of Sebela Pharmaceuticals, commented, "We look forward to obtaining approval in the U.S. so that tegoprazan can become a treatment option for patients and healthcare professionals."

K-CAB, which was launched in Korea in March 2019, recorded a cumulative outpatient prescription sales of 923.3 billion won as of last year. The drug has been approved in 22 countries, including Korea, and launched in 19 countries.