The domestically produced gastroesophageal reflux disease treatment 'Kecap (ingredient name: teguprazan)' has moved one step closer to the U.S. market. HK inno.N announced that the clinical phase 3 trial of Kecap in the United States has successfully ended, and it plans to knock on the door of the U.S. Food and Drug Administration (FDA) by the end of this year.
HK inno.N noted on the 24th that Kecap met both primary and secondary endpoints in the clinical phase 3 trial in the U.S., which included erosive esophagitis (EE) and non-erosive gastroesophageal reflux disease (NERD). This is the clinical trial result that has come three years after HK inno.N transferred Kecap to its U.S. partner, Sebela Pharmaceuticals, in 2021.
Kecap is a domestically produced potassium-competitive acid blocker (P-CAB). Gastroesophageal reflux disease treatments have evolved from first-generation histamine2 receptor antagonists (H2RA) to second-generation proton pump inhibitors (PPI) and to third-generation P-CABs. While PPIs are still in use, they have the drawback of being vulnerable to gastric acid and taking 4 to 5 days to show effects. In contrast, P-CAB formulations can be taken regardless of gastric acid levels and show immediate efficacy.
Kecap has demonstrated superiority over existing treatments (PPI) in the field of erosive esophagitis treatment. Prateek Sharma, a professor at the University of Kansas and president of the American Society for Gastrointestinal Endoscopy, said, “Heartburn and acid reflux are major symptoms of gastroesophageal reflux disease, but up until now, we have only talked about the improvement of heartburn symptoms,” adding, “Previous drug treatment studies did not show a reduction in acid reflux symptoms, unlike the P-CAB class, teguprazan.” This implies that the advantages of Kecap over existing treatments are clear.
Sebela, HK inno.N's U.S. partner, plans to submit a New Drug Application (NDA) for erosive esophagitis and non-erosive gastroesophageal reflux disease to the U.S. FDA in the fourth quarter, after completing the ongoing maintenance therapy clinical phase 3 trial for erosive esophagitis in the third quarter of this year.
HK inno.N developed Kecap after transferring technology from Japan's Raqualia in 2010. The company has signed technology and finished product export contracts with 48 countries so far and has launched Kecap in 15 countries. If Kecap receives FDA approval, it will be the first domestic P-CAB treatment to enter the U.S. market.
Kecap is expected to face off against the only competing drug in the U.S. market, Takeda Pharmaceutical's 'Boeqezna (bonoprazan).' Boeqezna recorded 122,000 prescriptions in just three quarters after its U.S. launch last year, effectively monopolizing the U.S. P-CAB market.
Industry sources view Kecap's relatively low price and its partner's position in the U.S. gastrointestinal pharmaceutical market as its competitive advantages.
According to a recent report by Korea Investment & Securities, the price of Boeqezna is $22 (30,148 won), while Kecap's price in the U.S. is estimated to be $17 (24,325 won). Additionally, Sebela, which is responsible for sales and marketing of Kecap in the U.S., is a specialized corporation in gastrointestinal pharmaceuticals and has a strong presence in the local market.
Kwak Dal-won, CEO of HK inno.N, said, “Domestic No. 30 new drug Kecap has successfully completed phase 3 clinical trials in the world's largest pharmaceutical market, the United States,” and added, “We will do our best to ensure that Kecap, in collaboration with Sebela, can establish a new standard for gastroesophageal reflux disease treatment in the global market, including the U.S.”
In addition to Kecap from HK inno.N, various domestic P-CAB formulations, such as 'Fexuclu (fexuprazan)' from Daewoong Pharmaceutical and 'Zacubo (zastaprazan)' from Jeil Pharmaceutical's subsidiary Onconic Therapeutics, have also entered overseas markets.
Fexuclu was launched in a total of 30 countries, including India, earlier this month. Zacubo has already signed technology export contracts with 21 countries.