HK inno.N’s P-CAB drug ‘K-CAB’ succeeds in U.S. Phase 3 바카라사이트 비타임 trial for GERD

[by Kang, In Hyo] HK inno.N's P-CAB-class drug, 'K-CAB’ (tegoprazan), developed for the treatment of gastroesophageal reflux disease (GERD), has successfully completed Phase 3 clinical trials in the United States. K-CAB achieved primary and secondary endpoints in both erosive esophagitis (EE) and non-erosive gastroesophageal reflux disease (NERD). Notably, the drug demonstrated superior efficacy compared to proton pump inhibitors (PPIs) in the treatment of erosive esophagitis during the second and eighth weeks of administration.

This 바카라사이트 비타임 success marks a significant milestone, achieved three years after HK inno.N licensed the K-CAB technology to Sebela Pharmaceuticals (hereinafter referred to as Sebela) in the U.S. in 2021. Building on these positive 바카라사이트 비타임 trial results, K-CAB’s entry into the U.S. market is expected to gain momentum in the future.

HK inno.N announced that its U.S. partner, Sebela, released the topline results of two U.S. Phase 3 바카라사이트 비타임 trials (TRIUMpH) on April 23 (local time), evaluating the efficacy of ‘tegoprazan (marketed in Korea as K-CAB)’ in patients with gastroesophageal reflux disease (GERD).

The recently announced U.S. Phase 3 바카라사이트 비타임 trials topline results were conducted on patients with erosive esophagitis and non-erosive GERD. These trials were carried out by ‘Braintree Laboratories, Inc.,’ a Sebela subsidiary specializing in gastrointestinal pharmaceuticals, HK inno.N’ U.S. partner under the licensing agreement established in 2021.

In the 바카라사이트 비타임 trials targeting erosive esophagitis and non-erosive GERD, tegoprazan met both primary and secondary endpoints. In particular, in the erosive esophagitis study, tegoprazan demonstrated statistically significant superiority over the PPI drug ‘lansoprazole’ in cure rates at the second and eight weeks, across the entire erosive esophagitis patient population as well as the subgroup with moderate to severe esophagitis (LA grades C and D). In the non-erosive GERD trial, tegoprazan showed a complete symptom improvement effect in both nighttime heartburn and heartburn-free days, as well as acid reflux symptoms.

In addition to the recently completed 바카라사이트 비타임 trials, the U.S. partner Sebela plans to finalize the ongoing Phase 3 바카라사이트 비타임 trial evaluating tegoprazan for ‘maintenance therapy in erosive esophagitis treatment’ in Q3. In the fourth quarter, the company intends to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), covering indications for erosive esophagitis and non-erosive esophageal reflux disease. Sebela also plans to submit the results of the TRIUMpH study to a leading peer-reviewed academic journal and present them at a major gastroenterology conference.

“We are pleased that tegoprazan achieved both primary and secondary endpoints in the 바카라사이트 비타임 trials for erosive esophagitis and non-erosive GERD. Particularly noteworthy is its superior therapeutic efficacy in erosive esophagitis compared to lansoprazole at both the two- and eight-week treatment intervals,” explained Alan Cooke, CEO of Sebela. “Sebela has maintained a strong commitment to the field of gastroenterology and to patients suffering from gastrointestinal conditions for over 40 years. Tegoprazan is anticipated to offer a new treatment option for patients who exhibit inadequate response to existing PPI treatments.”

“The 바카라사이트 비타임 data for tegoprazan in erosive esophagitis suggest that P-CABs may offer therapeutic superiority over PPIs,” said Dr. Felice Schnoll-Sussman, professor of 바카라사이트 비타임 medicine at Weill Cornell Medicine College and director of the Jay Monahan Center for Gastrointestinal Health. “It suggests that tegoprazan may offer an advantage over current treatment options.”

“Heartburn and acid reflux are the primary symptoms of GERD, yet most discussions have focused solely on the improvement of heartburn,” noted Dr. Prateek Sharma, a professor of medicine at the University of Kansas School of Medicine and current president of the American Society for Gastrointestinal Endoscopy (ASGE). “This may be due to the fact that previous 바카라사이트 비타임 trials have not demonstrated significant reductions in acid reflux symptoms, unlike the P-CAB tegoprazan.”

“It is very meaningful that K-CAB, a novel drug developed in Korea, has successfully completed Phase 3 바카라사이트 비타임 trials in the United States, the world’s largest pharmaceutical market,” said Kwak Dal-won, CEO of HK inno.N. “We will make every effort to establish tegoprazan as a new standard in the treatment of gastroesophageal reflux disease in the global market, including the United States, through close collaboration with Sebela and Braintree Laboratories.”

Meanwhile, in the U.S. Phase 1 바카라사이트 비타임 trial, tegoprazan was found to be unaffected by food intake and rapidly adjusted to gastric acidity to pH 4 within 45 minutes of administration. This suggests that tegoprazan could offer a differentiated treatment option for patients not controlled by PPIs, with the advantage of ‘rapid onset of efficacy.’

In the TRIUMpH study, individual adverse reactions occurred at a rate of less than 3%, with most cases being mild and temporary. The incidence of serious adverse events was also below 2%, showing no significant difference among 바카라사이트 비타임, PPI, and placebo groups. Additionally, the average serum gastrin levels in patients treated with either 바카라사이트 비타임 or lansoprazole remained within the normal range (0-180 pg/ml) throughout the study period.

Tegoprazan, the active ingredient of K-CAB, is the 30th novel 바카라사이트 비타임 developed in Korea by HK inno.N. As a P-CAB class therapeutic for GERD, K-CAB was launched in Korea in 2019 and achieved a cumulative prescription volume of KRW 705.4 billion (approximately USD 493 million) as of last year. It currently holds thetop position in outpatient prescription performance for peptic ulcer treatment in Korea, attributed to its rapid onset of action and proven safety in long-term administration over six months. The product has been licensed for technology or finished product exports in 48 countries, including Korea, with commercial launches already completed in 15 of those markets.