XZenith Biopharm, a Chinese company with minority ownership by Sihuan Pharma, has completed patient enrollment in a Phase II clinical study for its in-house developed proton pump inhibitor (PPI). The study focuses on the treatment of adult reflux esophagitis (RE) and the control of related symptoms, such as acid reflux, heartburn, sternal pain or discomfort, and belching reflux. The company is planning to initiate a Phase III study with the same indication before the end of this year.
Drug Metabolism and Clinical Differentiation Advantage
The drug, which filed for marketing approval in 2021 for the treatment of duodenal ulcers, undergoes multi-enzyme and non-enzyme metabolism. This unique metabolic pathway results in a low risk of drug interaction, providing a significant clinical differentiation advantage. This advantage is crucial in the competitive landscape of gastroesophageal reflux disease (GERD) treatments, where minimizing drug interactions can lead to improved patient outcomes and safety.
Plans for Phase III Study and Market Potential
With the successful completion of patient enrollment in the Phase II study, XZenith Biopharm is poised to advance its PPI into Phase III trials, aiming to further validate the drug’s efficacy and safety in treating RE and controlling associated symptoms. The company’s progress in developing this PPI highlights its commitment to addressing unmet medical needs in the field of gastroenterology.-Fineline Info & Tech
