Phase 3 Trials Initiated with Tegoprazan for the Treatment of Erosive Esophagitis and Non-erosive Reflux Disease

BRAINTREE, Mass., Oct. 28, 2022 /PRNewswire/ -- Sebela Pharmaceuticals^® has entered an exclusive partnership with HK inno.N Corporation to license tegoprazan in the United States and Canada. Under the agreement, Braintree Laboratories, a leader in gastroenterology and an affiliate of Sebela Pharmaceuticals, will be responsible for clinical development, registration, marketing, and sales in the United States and Canada. Tegoprazan, a novel potassium-competitive acid-blocker (P-CAB), is currently approved and marketed in several territories, including South Korea and China. 

Under the agreement, Braintree Laboratories, a leader in gastroenterology and an affiliate of Sebela Pharmaceuticals, will be responsible for clinical development, registration, marketing, and sales in the United States and Canada.

"We are delighted to add tegoprazan to our product pipeline," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "For over 35 years we have been committed to the gastroenterology space and to those affected by GI diseases. Tegoprazan expands our gastroenterology portfolio into an exciting new therapeutic class. Tegoprazan already has an established track record of safety and efficacy in multiple clinical studies and represents a potential new treatment option for people living with GERD."

"We are delighted to partner with Sebela Pharmaceuticals," Dal-Won Kwak, CEO, HK inno.N said in a statement. "Sebela has vast development, regulatory and commercial experience and expertise in the US, having obtained FDA approval and successfully launched multiple gastroenterology products over more than three decades. We believe Sebela Pharmaceuticals is the ideal partner to develop and commercialize tegoprazan in the United States and Canada." 

Following successful discussions with the US Food and Drug Administration, Sebela Pharmaceuticals has initiated Phase 3 studies of tegoprazan in patients with gastroesophageal reflux disease (GERD). The Phase 3 GERD program, known as the TRIUMpH program, includes a large, multi-center, double-blind study evaluating the safety and efficacy of tegoprazan versus a PPI control for the indications of healing of all grades of erosive esophagitis (EE) and the maintenance of EE healing and relief of heartburn. The TRIUMpH program also includes a large, multicenter, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of tegoprazan in patients with non-erosive reflux disease (NERD).  

About Tegoprazan

Tegoprazan is a novel agent in development for the treatment of acid-related gastrointestinal diseases. It is a member of a class of oral medications known as P-CABs, or potassium-competitive acid blockers, which have been shown to have rapid onset of action and the ability to control gastric pH for longer periods of time than proton pump inhibitors (PPIs). Tegoprazan has already received marketing authorization in multiple territories, including South Korea and China.

About GERD

GERD is a chronic and highly prevalent disorder caused by repeated backflow (or reflux) of gastric contents into the esophagus. GERD is characterized by a wide variety of symptoms, including heartburn and acid regurgitation. The main phenotypic presentations of GERD include non-erosive reflux disease (NERD) and erosive esophagitis (EE). EE is usually clinically differentiated from NERD by the presence of mucosal inflammation and lesions in the distal esophagus. Poorly treated EE can lead to Barrett's esophagus which increases the risk of esophageal cancer. It is estimated that GERD affects approximately 65 million people in the US with 60% to 70% suffering from NERD. While proton pump inhibitors are the mainstay of therapy for both EE and NERD, 35% to 54% of patients fail to achieve complete relief of symptoms. This represents a large unmet and underappreciated patient need. 

About Sebela Pharmaceuticals^® 

Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development. In addition, Sebela Women's Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth.

Please visit sebelapharma.com for more information or call 800-874-6756. 

HK inno.N is a public South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both the domestic and international markets. HK inno.N's key businesses are in the areas of prescription drugs, health supplements and beauty products. Since its establishment in 1984, through exports and global alliances, the company is growing into an international pharmaceutical firm. Drawing on the company's experience and knowhow in developing novel drugs, HK inno.N succeeded in launching new GERD treatment 'K-CAB®" (Tegoprazan), the 30th novel drug to be developed and registered in Korea, to great acclaim. For more information, visit https://www.innon.com/eng.