HK Innoen's New Drug 'K-CAB' Announces Successful Top-Line Results in US Phase 3 Trial

HK Innoen esophageal reflux disease new drug 'K-CAB (active ingredient Tegoprazan)'. Photo by HK Innoen

HK Innoen's new drug for esophageal reflux disease, 'K-CAB' (active ingredient: Tegoprazan), has successfully completed Phase 3 clinical trials in the United States. This achievement comes three years after HK Innoen licensed the technology to the US company 'Sebela' in 2021, and is expected to accelerate K-CAB's entry into the US market.

HK Innoen announced on the 24th that its US partner Sebela had released the top-line results of two US Phase 3 clinical trials, named 'TRIUMpH', evaluating Tegoprazan (marketed in Korea as K-CAB) in patients with gastroesophageal reflux disease (GERD), on the 23rd (local time).

The US Phase 3 clinical trials, for which top-line results were announced, targeted patients with erosive esophagitis (EE) and non-erosive gastroesophageal reflux disease (NERD). The US trials were conducted by Braintree, a gastrointestinal medicine specialist subsidiary of Sebela, HK Innoen's US partner with whom a license agreement was signed in 2021.

In the clinical trials for erosive esophagitis and non-erosive gastroesophageal reflux disease, Tegoprazan met both the primary and secondary endpoints. Notably, in the clinical trial for erosive esophagitis, Tegoprazan demonstrated statistical superiority over the existing acid suppressant PPI (lansoprazole) in the healing rates at both 2 weeks and 8 weeks, for the entire patient group with erosive esophagitis as well as for those with moderate or higher grade esophagitis (LA grades C and D).

In the non-erosive gastroesophageal reflux disease clinical trial, Tegoprazan showed complete symptom improvement in both heartburn (including nighttime and heartburn-free days) and acid reflux.

Meanwhile, Sebela, the US partner, is also conducting an additional Phase 3 clinical trial for the 'maintenance therapy of erosive esophagitis', which is expected to be completed in the third quarter of this year. In the fourth quarter of this year, the company plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA), including indications for both erosive esophagitis and non-erosive gastroesophageal reflux disease. Sebela intends to submit the results of the TRIUMpH study to a leading academic journal and present them at major gastroenterology conferences.

Alan Cook, President and CEO of Sebela Pharmaceuticals, stated, "We are pleased that Tegoprazan achieved both primary and secondary endpoints in clinical trials for erosive esophagitis and non-erosive gastroesophageal reflux disease. In particular, it is encouraging that Tegoprazan demonstrated superior healing effects compared to lansoprazole at both 2-week and 8-week treatments in erosive esophagitis." He added, "Sebela has been dedicated to the field of gastroenterology and to patients affected by gastrointestinal diseases for over 40 years. We expect that Tegoprazan will provide a new treatment option for patients who do not respond adequately to existing PPI therapies."

Kwark Dalwon, CEO of HK Innoen, commented, "It is very meaningful that K-CAB, a new drug developed in Korea, has successfully completed Phase 3 clinical trials in the United States, the world's largest pharmaceutical market." He continued, "Through close collaboration with Sebela and Braintree, we will do our utmost to ensure that Tegoprazan establishes itself as the new standard of care for esophageal reflux disease in the US and global markets."

Tegoprazan is the active ingredient of K-CAB, the 30th new drug developed in Korea by HK Innoen. K-CAB is a P-CAB class new drug for esophageal reflux disease. Launched in Korea in 2019, it has recorded cumulative prescription sales of 705.4 billion KRW through last year. With features such as rapid onset of action and proven safety for long-term use over six months, it ranks first in outpatient prescriptions for peptic ulcer medications in Korea. HK Innoen has signed technology transfer or finished product export agreements with 48 countries including Korea, and the drug has been launched in 15 of these countries.