Cinclus Pharma includes the last patient in its phase II eGERD study
Prenumeration
Cinclus Pharma Holding AB (publ), a biopharmaceutical company focused on the development of a novel treatment for gastroesophageal reflux disease (“GERD”), today announces that the last patient has been included in the company's phase II study of the company's leading drug candidate linaprazan glurate.
The study includes a total of 248 patients with severe erosive GERD (eGERD). The goal is to find the optimal dose for future phase III studies, based on healing of erosive esophagitis after four weeks.
"Patient recruitment in our phase II clinical trial conducted in the United States and Eastern Europe has recovered well after the pandemic, despite the crisis caused by the invasion of Ukraine. Thanks to hard work from the entire organization, we have now included the last patient. Thus, we have taken another important step towards driving a paradigm shift in the treatment of gastric acid related diseases," said Christer Ahlberg, CEO of Cinclus Pharma.
Now follows about two months of treatment of the last patient before the study closes. Validation and analysis are expected during the month and topline results of expected studies in October. The study results will form the basis for the study design of the upcoming registration-based phase III studies that are expected to begin in 2023.
Linaprazan glurate is a prodrug and belongs to the class P-CAB and is being developed for the treatment of severe GERD. Effective P-CAB is the new treatment regimen that is expected to replace the proton pump inhibitors (PPIs), and Cinclus Pharma's goal is to make linaprazan glurate best in class and to achieve a paradigm shift in the care of gastric acid related diseases. Thanks to the unique properties of linaprazan glurate, Cinclus Pharma has the chance to develop a drug that is clearly differentiated and well positioned in relation to other P-CABs and PPIs.