HK inno.N's gastroesophageal reflux disease new drug 'K-CAB (ingredient name Tegoprazan)' has successfully passed the final hurdle for local new drug approval applications as it achieved success in Phase 3 clinical trials in the United States. U.S. partner company Sebela Pharmaceuticals plans to apply for new drug approval from the U.S. Food and Drug Administration (FDA) within this year.
HK inno.N announced on the 8th that Sebela had released the key results of Phase 3 clinical trials conducted in the U.S. evaluating the maintenance therapy after treatment of erosive esophagitis (EE) with K-CAB on the 7th (local time). K-CAB is the 30th new drug developed by HK inno.N, launched domestically in 2019 as a new drug for gastroesophageal reflux disease in the potassium competitive acid secretion inhibitor (P-CAB) class.
This clinical trial was conducted by Braintree Laboratories, a specialized subsidiary of Sebela for gastrointestinal pharmaceuticals. After a maximum of 8 weeks of initial treatment, patients with treated erosive esophagitis (EE) were randomly assigned to receive either 100 mg or 50 mg of K-CAB, or 15 mg of another esophagitis medication (lansoprazole), for 24 weeks of maintenance therapy.
In the evaluation of the treatment effect maintenance rate over 24 weeks, the overall patient group demonstrated that the efficacy was not inferior in all dosage groups of K-CAB compared to the lansoprazole treatment group. Notably, in patients with moderate or severe esophagitis, K-CAB showed higher efficacy than lansoprazole. Statistical superiority was confirmed in the 100 mg treatment group.
Earlier, the company announced in April through Braintree that K-CAB had met all evaluation criteria in the U.S. Phase 3 clinical trial for non-erosive gastroesophageal reflux disease. Subsequently, they were able to validate another target disease in this trial.
Based on these clinical results, Sebela plans to apply for new drug approval from the FDA in the fourth quarter of this year for erosive esophagitis and non-erosive gastroesophageal reflux disease indications. The Phase 3 study results are expected to be published in an international academic journal.
Alan Cooke, CEO of Sebela, noted that 'Tegoprazan demonstrated excellent maintenance efficacy across the entire patient population, including those with moderate to severe erosive esophagitis, and showed the ability to control persistent symptoms of heartburn.' He added, 'With a safety profile similar to existing treatments, it has the potential to become an innovative treatment option that can meet the unmet needs of U.S. patients.'
Kwak Dal-won, CEO of HK inno.N, expressed, 'I am delighted that K-CAB has successfully completed the Phase 3 trials for the treatment of erosive esophagitis and non-erosive gastroesophageal reflux disease, as well as this maintenance therapy trial.' He added, 'The entry into the U.S., the world's largest pharmaceutical market, is within sight. We will do our utmost to ensure that the new drug approval application to the FDA proceeds smoothly in collaboration with our partner company.'