HK Innoen 'K-CAB', Successful Long-Term Use Phase 3 Clinical Trial

HK Innoen 'K-CAB Tablet' (Photo by HK Innoen)

[Asia Economy Reporter Lee Chun-hee] The long-term efficacy and safety of HK inno.N's gastroesophageal reflux disease treatment 'K-CAB tablets' have been confirmed.

On the 20th, HK inno.N announced the results of a Phase 3 clinical trial evaluating the efficacy and safety of K-CAB tablets related to maintenance therapy after treatment of gastroesophageal reflux disease.

This clinical trial was conducted on 351 patients confirmed to have healed erosive gastroesophageal reflux disease through endoscopy at 33 medical institutions nationwide. After taking K-CAB tablets for up to six months, it was confirmed that the treatment effects on major symptoms of gastroesophageal reflux disease, such as not only erosions seen on endoscopy but also heartburn and acid reflux, were maintained.

In particular, K-CAB tablets showed superior effects compared to the control group receiving PPIs in maintenance therapy for patients with moderate or higher severity, and showed similar effects regardless of the ‘CYP2C19’ genotype. Existing PPI products are known to have limitations with significant differences in efficacy depending on the CYP2C19 genotype. In fact, in this clinical trial, the PPI control group showed differences in efficacy depending on the CYP2C19 genotype. However, K-CAB tablets, which belong to the P-CAB class, showed similar efficacy regardless of the CYP2C19 genotype.

In terms of safety, K-CAB tablets had a significantly lower incidence rate of adverse drug reactions compared to the control group. Furthermore, it was evaluated that long-term administration is safe without concerns about the increase of ‘gastrin’, a hormone that promotes gastric acid secretion, or nutritional deficiencies.

Song Geun-seok, Executive Vice President of Research and Development (R&D) at HK inno.N, stated, "This clinical trial not only secured the long-term safety and efficacy of the new P-CAB drug K-CAB tablets but also demonstrated its differentiation compared to PPIs," adding, "There is a high possibility that superiority over PPIs will be shown when conducting clinical trials in the United States, where there are many patients with specific genotypes that reduce PPI efficacy and patients with moderate or higher severity." Based on the results of this clinical trial, HK inno.N plans to initiate additional indication procedures for K-CAB tablets and accelerate its entry into the U.S. market.