-  New investigational data evaluating Fexuprazan in a Korean clinical trial program for healing erosive esophagitis (EE) regardless of food intake, and in a Chinese pivotal clinical trial program for the treatment of EE

SEOUL, South Korea and CHICAGO, May 19, 2023 /PRNewswire/ -- Daewoong Pharmaceutical (CEO Lee Chang-jae and Jeon Sengho) announced on the 19th that they set up a booth at the Digestive Disease Week^® 2023 (DDW 2023) held in Chicago, USA and revealed new clinical data through two poster sessions demonstrating the efficacy and safety of Fexuclue^® (active ingredient name: Fexuprazan) on patients with gastroesophageal reflux disease (GERD).

‌DDW is the world's largest conference where over 10,000 doctors, researchers, and gastroenterology experts are gathered from all around the world and share their recent studies and clinical practices. Throughout the conference, in addition to two poster sessions, Daewoong have a physical presence located at booth #4729, where the representatives of the company presented on-site to provide medical information regarding Daewoong's Fexuprazan and were able to make active scientific and academic exchanges with gastroenterologist from all over the world based on clinical trial results.

On May 7th local time, Daewoong Pharmaceutical had two poster sessions, which were an investigator initiated trial (IIT) conducted in South Korea to compare the healing rates of a mucosal breaks by Fexuprazan before and after food intake, and a pivotal phase 3 clinical trial conducted in China to assess the efficacy and safety of Fexuprazan in treating the EE.

The IIT led by Sung In-Kyung, a professor of gastroenterology at Konkuk University, assessed the efficacy and safety of Fexuprazan in patients with erosive esophagitis. The study compared the outcomes of patients who took the investigational product once a day before and after food intake. The study found no significant difference in healing rates between the group that took the investigational product before and after food intake. The ability to administer Fexuprazan irrespective of food intake provides potential differentiation from most PPIs.

Professor Sung In-Kyung who oversaw the clinical trial said, "In this study, Fexuprazan is the first P-CAB agent to demonstrate equal effectiveness regardless of food intake, enabling convenient administration. At two and four weeks, Fexuprazan has shown the potential to provide a faster and stronger in suppressing the production of gastric acid than PPIs. We anticipate that the investigational use of Fexuprazan will exhibit excellent efficacy in other conditions resulting from excessive gastric acid secretion."

Additionally, the randomized controlled phase 3 clinical trial that was conducted in China focusing on erosive esophagitis compared the healing rates of mucosal breaks observed through upper endoscopy over an eight-week period, which served as the effectiveness evaluation index. The study revealed that the percentage of mucosal healing rate by 8 weeks in the Fexuprazan group was 97.3% (145 out of 149 people) and that in the Esomeprazole group was 97.9% (143 out of 146 people). It demonstrates that Fexuprazan is non-inferior to Esomeprazole, which serves as an active comparator drug. Furthermore, a safety evaluation was carried out to assess adverse drug reactions, and the results were similar between Fexuprazan: (19.4%) and the active comparator drug, Esomeprazole (19.6%). No unexpected serious adverse reactions were observed, indicating its safety profile.

Dr. Xiao Yinglian, the presenter of the phase 3 clinical trial in China, and a professor at Sun Yat-sen University, said, "Fexuprazan has several advantages over PPIs. It starts working within just one day and shows equal effectiveness regardless of food intake. P-CAB drugs will gradually take the place of PPIs, and Fexuprazan has the potential to lead the transition".

Aside from the poster presentations at DDW 2023, Daewoong successfully held a special event outside of the traditional DDW session, "Fexuclue Reception Night" held in Chicago, USA on May 8th (local time). At Fexuclue Reception Night, about 70 key opinion leaders from around the world, including executives from Korean and overseas digestive societies, actively discussed the features of P-CAB including Fexuprazan as well as the treatment guideline for GERD using P-CAB.

Lee Chang-jae, CEO of Daewoong Pharmaceutical said, "We had the opportunity to showcase the potential effectiveness of Fexuprazan to doctors and researchers specializing in gastrointestinal diseases at the world's largest conference, DDW 2023 during the presentation of study results related to the erosive reflux disease that can be treated by Fexuprazan", adding "We have plans and ongoing clinical trials in and out of the country, aiming to expand the range of diseases that can be treated by Fexuprazan. We will concentrate our resources on gathering data that can demonstrate the efficacy of Fexuprazan and developing various formulations to enhance the value of Fexuprazan."

About Fexuprazan

Fexuprazan is investigational new drug in the United States of America. Outside the United States of America, Fexuprazan is known with a brand name of Fexuclue for GERD treatment. Fexuclue is an approved prescription drug for the treatment of GERD in South Korea, Chile, Ecuador and the Philippines. Fexuclue is registered trademarks of Daewoong Pharmaceutical. Any other trademarks referred to in this press release are the property of their respective owners. 

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. These statements are subject to various risks, uncertainties, and assumptions that could cause actual results to differ materially from those anticipated in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.