HK Innoen 'K-Cab' Starts Phase 3 Clinical Trial in US... Targeting $4 Trillion US Market

[Asia Economy Reporter Chunhee Lee] HK Innoen's gastroesophageal reflux disease (GERD) new drug 'K-CAB' (active ingredient Tegoprazan) has entered Phase 3 clinical trials in the United States.

HK Innoen announced on the 20th that Braintree Laboratories, a subsidiary of Sebela US, a US gastrointestinal pharmaceutical specialist company and local partner, recently received approval from the US Food and Drug Administration (FDA) for the Phase 3 clinical trial plan of Tegoprazan and has started the final clinical trial. Actual patient dosing has already begun.

This Phase 3 trial will be conducted as two clinical studies comparing the efficacy and safety of Tegoprazan and proton pump inhibitors (PPIs) for erosive GERD treatment and maintenance of therapeutic effect, as well as for non-erosive GERD.

K-CAB is a new drug developed by HK Innoen belonging to the potassium-competitive acid blocker (P-CAB) class. Unlike PPI drugs, which must be taken 30 minutes before meals and cause discomfort due to increased acid secretion at night, with concerns over side effects such as osteoporosis and stroke, P-CAB drugs can be taken regardless of meal times and also improve nighttime heartburn.

Previously, HK Innoen signed a technology export contract for K-CAB to the US and Canada in December last year and announced the results of the US Phase 1 clinical trial in April. An HK Innoen official explained, "From the design stage of Phase 1, we practically prepared to conduct Phase 2 simultaneously," adding, "After consultations with the FDA, we were able to skip Phase 2 and proceed directly to Phase 3."

The US market size for GERD treatments was about 4 trillion KRW last year, making it the largest market worldwide. However, there is only one P-CAB drug approved by the US FDA so far. Phathom Pharmaceuticals, jointly established by Japan's Takeda and US Fraser Healthcare, received FDA approval for 'Voquezna' (active ingredient Vonoprazan) for use in combination antibiotic therapy for Helicobacter pylori eradication.

Dalwon Kwak, CEO of HK Innoen, said, "Following recent launches in China and Mongolia and subsequent US clinical trials, the global expansion speed of K-CAB is accelerating," adding, "This US clinical trial is expected to positively impact achieving our goal of entering 100 global countries, including the European market."

Alan Cooke, CEO of Sebela, also stated, "We are very pleased to expand our GERD-related pipeline through K-CAB," adding, "K-CAB has already proven safety and efficacy in many clinical studies and will provide a new treatment option for patients worldwide."

This content was produced with the assistance of AI translation services.