HK Innoen announced on the 13th that its U.S. partner, Sevela Pharmaceuticals, a subsidiary and specialist in gastrointestinal medicines, submitted a New Drug Application (NDA) for the treatment of gastroesophageal reflux disease, 'K-Cab' (ingredient name Tegoprazan), to the U.S. Food and Drug Administration (FDA) on the 9th (local time).
This NDA aims for simultaneous approval for three indications: ▲ Non-erosive gastroesophageal reflux disease (NERD) ▲ Erosive esophagitis (EE) ▲ Maintenance therapy after treatment of erosive esophagitis.
According to HK Innoen, the submission of this NDA was based on superior clinical data obtained from a Phase 3 clinical trial (TRIUMpH program) involving over 2,000 U.S. patients. The clinical results showed that the K-Cab treatment group for patients with non-erosive gastroesophageal reflux disease demonstrated superiority over the placebo in the proportion of days without heartburn over 24 hours.
Additionally, statistically significant superiority was confirmed at both the 2-week and 8-week points compared to the competing drug 'Lansoprazole' in all grades (LA grades A-D) of erosive esophagitis patients. Furthermore, K-Cab showed superior effects compared to the competing drug during maintenance therapy after 24 weeks of healing from erosive esophagitis.
Gwak Dal-won, CEO of HK Innoen, stated, "We are pleased that K-Cab is progressing through the new drug approval process with excellent clinical trial results in the U.S.," and added, "As a global best-in-class product leading the world market, we will actively pursue exports to Europe and development in Japan."
Meanwhile, K-Cab is the 30th domestically produced new drug and belongs to the 'Potassium-competitive Acid Blocker (P-CAB)' class of drugs. K-Cab has emerged as a drug that can replace the existing market-leading drug, 'Proton Pump Inhibitors (PPI)', through its rapid and reliable acid suppression effect.
