At KDDW 2023, HK inno.N’s K-CAB has emerged as a trailblazer in strengthening its global position
November 20, 2023
At KDDW 2023, HK inno.N’s K-CAB has emerged as a trailblazer in strengthening its global position as a novel drug
HK inno.N took part in the nation’s largest international symposium on gastroenterology, “KDDW 2023,” hosted by eight associations specializing in gastroenterology
▲ Oral presentations on healing rates after short-term administration and ▲ maintenance rates during post-treatment maintenance
▲ Poster presentations on the incidence of depression and ▲ improvement of functional dyspepsia symptoms
Extraordinary healing rates confirmed regardless of the severity of esophagitis symptoms and CYP2C19 genotype
HK inno.N's recently developed drug, K-CAB, addressing gastroesophageal reflux disease, has confidently demonstrated its competitive edge as a domestically created novel drug. This was proved through the latest research findings presented at the nation’s largest symposium, attended by gastroenterological experts from both domestic and international realms.
On November 20th, the bio-pharmaceutical company HK inno.N (CEO: Kwak Dalwon), announced the company's participation in the 7th Korea Digestive Disease Week (referred to as “KDDW 2023”). This gastroenterology-centered symposium took place from November 16th to November 18th, during which the company shared significant clinical findings related to K-CAB, featuring the active ingredient tegoprazan. “KDDW 2023” is considered the nation’s largest international symposium, organized by the Korean Society of Gastroenterology and co-hosted by eight domestic associations specializing in gastroenterology.
The recent research presentation encompassed four studies: 1) a multicenter phase 4 trial validating the healing rates at 2 weeks and 4 weeks following K-CAB administration in patients with erosive reflux disease (ERD); 2) a phase 3 trial assessing the safety and efficacy of K-CAB in patients with healed ERD, confirmed through endoscopy under maintenance treatment; 3) a data analysis for actual use confirming the incidence of depression during K-CAB administration compared to proton pump inhibitors (PPI); 4) a study affirming the effects of K-CAB in patients with functional dyspepsia (FD).
Initially, concerning the investigation into the healing rates following short-term administration of K-CAB in patients with ERD, it was led by Dr. Choi Seokchae from the Department of Gastroenterology at Wonkwang University Hospital. The oral presentation was conducted by Dr. Shin Cheolmin from the Department of Gastroenterology at Seoul National University Bundang Hospital.
The trial results revealed the superiority of 50mg K-CAB administration in terms of healing rates at both the 2-week and 4-week marks compared to the control group receiving proton pump inhibitors (PPI).
Confirmed were variations in healing rates depending on symptom severity or genotype. Proton pump inhibitors (PPI) exhibited differences in healing rates relative to the severity of esophagitis symptoms or CYP2C19 genotype. In contrast, K-CAB, categorized as a P-CAB class medication, demonstrated notable healing rates irrespective of the severity of moderate to severe esophagitis (LA grade C/D) or CYP2C19 genotype. Moreover, it showed a rapid reaction and effectiveness in alleviating symptoms of chest discomfort.
Likewise, the findings from a study validating the safety and efficacy of K-CAB in the maintenance treatment of patients with confirmed healing of ERD through endoscopy were reported. The study, focusing on administration of 25 mg K-CAB for a duration of up to 6 months, affirmed the sustained therapeutic effects and the safety of prolonged usage. In particular, in the maintenance treatment of moderate to severe cases, it exhibited superior effectiveness when compared to the proton pump inhibitors (PPI) group and proved to be effective irrespective of CYP2C19 genotype.
Two poster presentations were additionally delivered. Dr. Kim Joonseong from the Department of Gastroenterology at Incheon St. Mary's Hospital and Dr. Kim Seonghwan from the Department of Psychiatry at Yeouido St. Mary's Hospital presented research on “the relationship between K-CAB and the risk of depression” using data sourced from the Health Insurance Review and Assessment Service.
This study focused on comparing the incidence of depression between users of 50mg K-CAB and PPI class medications. The outcomes established the safety of K-CAB in relation to depression, both in short-term and long-term usage of the drug. The study revealed that the risk of developing depression was 2.18 times higher in the PPI user group compared to K-CAB users. Furthermore, individuals who use PPI for an extended period, surpassing 180 days, faced a 2.11 times higher risk.
Dr. Heo Cheolwoong from the Department of Gastroenterology at Yongin Severance Hospital presented a poster discussing the research on “the impact of K-CAB in patients with functional dyspepsia (FD),” which was spearheaded by Dr. Yoon Younghun from the Department of Gastroenterology at Gangnam Severance Hospital.
The study aimed to assess the general amelioration in individuals experiencing symptoms of functional dyspepsia (FD) following administration of 50 mg K-CAB. The study revealed prominent rates of symptom improvement, with 86.7% in the 8-week treatment cohort and 74.6% in the 4-week treatment cohort. Additionally, the research affirmed that the noticeable effects of symptom improvement were observed in patients diagnosed with both functional dyspepsia (FD) and gastroesophageal reflux disease (GERD).
HK inno.N's CEO, Kwak Dalwon, emphasized that K-CAB stands out as a leading product that drives a paradigm shift in treatment. He states, “we have been actively engaging in significant symposiums both domestically and internationally to disseminate the latest research discoveries. We are determined to consistently enhance our unique competitive edge as a domestically developed novel drug, through unceasing research and development efforts.”
K-CAB, designated as Korea’s 30th Novel Drug, represents a novel P-CAB class drug designed for gastroesophageal reflux disease (GERD). Since its introduction in 2019, K-CAB has maintained a commanding presence in the domestic market, securing its position as a market leader for the fourth consecutive year. As of October this year, it has achieved remarkable sales figures, totaling KRW 478.8 billion.
[References]
- Research titles
▶ Oral presentation 1: COMPARISON OF TEGOPRAZAN AND LANSOPRAZOLE IN PATIENTS WITH EROSIVE ESOPHAGITIS: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-COMPARATOR PHASE 4 TRIAL
▶ Oral presentation 2: RANDOMISED CLINICAL TRIAL: COMPARISON OF TEGOPRAZAN AND LANSOPRAZOLE AS MAINTENANCE THERAPY FOR HEALED MILD EROSIVE OESOPHAGITIS
▶ Poster presentation 1: USE OF POTASSIUM-COMPETITIVE ACID BLOCKERS AND RISK OF DEPRESSION: A NATIONWIDE POPULATION-BASED STUDY
▶ Poster presentation 2 - EFFICACY OF TEGOPRAZAN IN PATIENTS WITH FUNCTIONAL DYSPEPSIA: A PROSPECTIVE, MULTICENTER, SINGLE-ARM STUDY
- Terminology
▶PPI (Proton Pump Inhibitor)
▶P-CAB (Potassium-Competitive Acid Blocker)
▶ERD (Erosive Reflux Disease)