inno.N

K-CAB (A P-CAB class new drug for GERD) Demonstrates Superior Efficacy Over PPIs-Paving the Way for Global Market Expansion

HK inno.N Announces Positive Topline Results from US Phase 3 Trials of K-CAB (tegoprazan)

- Sebela Pharmaceuticals, exclusive US licensee, announces key results from US Phase 3 studies

- Met all primary and secondary endpoints in erosive esophagitis (EE) and non-erosive reflux disease (NERD)

- Demonstrated superior healing efficacy of all EE grades at weeks 2 and 8 compared to PPI (lansoprazole)

- Achieved significant symptom relief (24-hour and overnight heartburn, acid regurgitation) versus placebo in NERD

- Serum gastrin levels remained within normal range; safety and tolerability similar to PPI and placebo

HK inno.N announced the successful completion of US Phase 3 clinical trials for K-CAB (tegoprazan), its novel treatment for gastroesophageal reflux disease (GERD). K-CAB achieved all primary and secondary endpoints in trials for both erosive esophagitis (EE) and non-erosive reflux disease (NERD). Notably, K-CAB demonstrated superior efficacy compared to PPI (lansoprazole) in healing EE at weeks 2 and 8.

This is an impressive feat of HK inno.N made three years after the technology licensing to Sebela Pharmaceuticals, a US pharmaceutical company, in 2021, and going forward, K-CAB's US market entry is expected to gain the full momentum.

On April 23 (local time), HK inno.N confirmed that Sebela Pharmaceuticals, its exclusive US partner, presented the topline results of the TRIUMpH program — a set of two Phase 3 studies evaluating tegoprazan (marketed as K-CAB in South Korea) in US GERD patients.

The trials, conducted by Braintree Laboratories, Inc. (a subsidiary of Sebela Pharmaceuticals specializing in gastroenterology), evaluated K-CAB in both EE and NERD patient populations. Tegoprazan successfully met all primary and secondary endpoints in both studies.

Specifically, in the EE trial, tegoprazan demonstrated statistically significant superiority over lansoprazole in achieving esophageal healing at weeks 2 and 8 across all EE grades, including moderate to severe esophagitis (LA Grade C or D).

In the NERD trial, tegoprazan provided complete symptom relief for both heartburn (daytime and overnight) and acid regurgitation.

In addition, Sebela Pharmaceuticals plans to complete a Phase 3 study for EE maintenance therapy in Q3 2025 and submit a New Drug Application (NDA) covering both EE and NERD indications to the FDA in Q4 2025. The company also plans to publish the TRIUMpH results in a leading peer-reviewed journal and present them at a major gastroenterology conference.

Alan Cooke, President and CEO of Sebela Pharmaceuticals, stated:

“We are delighted with tegoprazan’s Phase 3 results, achieving all primary and secondary endpoints in both EE and NERD trials. The superior efficacy in EE healing at weeks 2 and 8, compared to lansoprazole, is particularly compelling. For over 40 years, Sebela Pharmaceuticals has been dedicated to advancing gastroenterology treatments. We are excited by the prospect of offering tegoprazan as a new option for GERD patients whose symptoms are not adequately controlled by conventional PPIs.”

Felice Schnoll-Sussman, MD, Professor of Clinical Medicine at Weill Cornell Medical College and Director of the Jay Monahan Center for Gastrointestinal Health, commented:

“The data on tegoprazan for erosive esophagitis confirm that the P-CAB class can outperform PPIs and suggest tegoprazan offers clear advantages over existing agents.”

Prateek Sharma, MD, Professor at the University of Kansas School of Medicine and President of the American Society of Gastrointestinal Endoscopy, noted:

“Heartburn and acid regurgitation are the hallmark symptoms of GERD, yet clinical trials have traditionally focused only on heartburn relief. Tegoprazan is notable for demonstrating clear efficacy in reducing both symptoms, including acid regurgitation, which PPIs have struggled to address.”

Dalwon Kwak, CEO of HK inno.N, remarked:

“Successfully completing US Phase 3 trials of K-CAB-a South Korea-developed drug-is a meaningful achievement. Through our close collaboration with Sebela Pharmaceuticals and Braintree Laboratories, we are committed to establishing tegoprazan as a new standard GERD therapy in global markets, including the United States.”

In a separate US-based Phase 1 study, tegoprazan demonstrated rapid acid control (pH>4) within 45 minutes of administration, with no food effect-evidence supporting its differentiated profile as a rapid-onset therapy.

In the TRIUMpH studies, treatment-emergent adverse events occurred in fewer than 3% of patients and were generally mild and transient. The incidence of serious adverse events was below 2% across all groups, with no significant difference between tegoprazan, PPI, and placebo arms. Mean serum gastrin levels for both tegoprazan and lansoprazole remained within normal range (0–180 pg/mL) throughout the trials.

Tegoprazan, the active ingredient in K-CAB, is South Korea’s 30th novel drug, developed by HK inno.N. As a potassium-competitive acid blocker (P-CAB) for GERD treatment, K-CAB was first launched in South Korea in 2019 and has achieved cumulative outpatient prescription sales of KRW 705.4 billion as of 2024. Its key features include rapid onset of action and proven safety for long-term use (up to six months). K-CAB continues to lead the Korean outpatient prescription market for peptic ulcer medications. HK inno.N has licensed or distributed K-CAB in 48 countries, with official launches in 15 markets to date.

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(Reference information)

About TRIUMpH
The TRIUMpH program comprises two phase 3 studies of tegoprazan in US patients with gastroesophageal reflux disease (GERD), including △ erosive esophagitis (EE) and △ non-erosive reflux disease (NERD). Both studies were multicenter, double-blind trials, conducted among the US patient population representative of the demographically diverse US population.

The phase 3 EE study was designed as a large, multi-center, double-blind study (n=1,250, including 463 patients with esophagitis of LA Grade C/D) evaluating the safety and efficacy of tegoprazan versus lansoprazole for indications including the healing of all grades of EE, maintenance of EE healing and relief of heartburn.

The primary and secondary efficacy endpoints in the EE healing phase were hierarchically structured, with secondary endpoint testing commencing for continued evaluation only if the preceding endpoints were statistically significant. All pre-specified efficacy endpoints ^{(Table 1)} were tested and achieved statistical significance.

Table 1. TRIUMpH-EE(EE) efficacy endpoints

The phase 3 NERD study was designed as a large, multicenter, double-blind study (n=800) for comparative evaluation on the safety and efficacy of tegoprazan versus placebo. The primary endpoint was the percentage of 24-hour heartburn-free days. Additional key endpoints included percentage of days without overnight heartburn and percentage of days without acid regurgitation.

lPrimary endpoint: Percentage (%) 24-hour heartburn-free days in 4 weeks

lSecondary Endpoints: Percentage (%) of patients with complete resolution of presenting symptoms (heartburn and acid regurgitation) at week 4

* Days with no reports of heartburn symptoms in the morning or afternoon log were defined as the ‘24-hour heartburn-free days'.

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Gastroesophageal reflux disease (GERD)

- GERD: Chronic reflux of stomach contents into the esophagus causing heartburn, acid regurgitation, or complications. Patients are classified as EE or NERD based on endoscopy findings.

- Erosive Esophagitis (EE): GERD symptoms with visible mucosal injury.

- Non-Erosive Reflux Disease (NERD): GERD symptoms without mucosal injury.

LA Grade (The Los Angeles Classification)

- It is a classification system for diagnosis of erosive esophagitis, first presented at the Los Angeles World Congress of Gastroenterology , and the grades range from A to D, depending on the length of the mucosal breaks and their size in the direction of the esophageal circumference.

P-CAB (Potassium Competitive Acid Blocker/HK inno.N K-CAB (tegoprazan))

- The mechanism is to block the secretion of gastric acid through competitive binding directly to the potassium ions (K⁺) of the proton pump without the need for activation by gastric acid, i.e. by disrupting with the binding of potassium ions to the proton pump.

- Therefore, P-CABs can be administered regardless of food intake, exhibiting a fast and strong effect of inhibiting gastric acid secretion from the first day of administration, and its efficacy lasts longer than that of PPIs, demonstrating superior prevention of overnight acid secretion.

PPI (Proton Pump Inhibitor/e.g., lansoprazole)

- PPIs block gastric acid secretion by irreversibly inhibiting the gastric proton pump (Hydrogen/Potassium Adenosine Triphosphatase; H+/K+-ATPase), which is involved in the final step of gastric acid secretion.

- A PPI is a prodrug, activated by gastric acid and then binds to the proton pump to inhibit gastric acid secretion. Due to this mechanism, PPIs must be administered before meals and they achieve the maximum efficacy after repeated administration (3-5 days).

HK inno.N Corp.

HK inno.N Corp was established in 1984 as the department of pharmaceutical business within CJ Cheil Jedang, grown to a new business entity under the name of CJ HealthCare in 2014. The company became a subsidiary of Kolmar Group in 2018 and changed its name to HK inno.N Corp. in 2020 to begin a new chapter. Under the company’s mission of ‘Creating a healthier world where customers can enjoy a better life,’ HK inno.N Corp. has distinctive, technology-driven business competitiveness in the prescription drugs and health and beauty sectors. In the prescription drugs sector, the company has been strategically focusing its capabilities on developing innovative, high value-added pharmaceutical products, drawing on its know-hows in the development of‘K-CAB,’ the 30th new drug of South Korea, and leading its path of growth into a new blockbuster drug. In the health and beauty sector, starting from the remarkable success of the hangover relief product ‘CONDITION,’ the future value of HK inno.N Corp. continues to grow through expansion into the beverage, health food, and cosmetics sectors. www.inno-n.com

Sebela Pharmaceuticals^® 

Sebela Pharmaceuticals^® is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been the market leader in colonoscopy screening preparations for over 40 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has a pipeline of gastroenterology late-stage clinical development programs. www.sebelapharma.com