Cinclus Pharma has announced the completion of Investigational Medicinal Product (IMP) manufacturing for its Phase III study of linaprazan glurate, a novel Potassium-Competitive Acid Blocker (P-CAB), for the treatment of erosive gastroesophageal reflux disease (eGERD). The company anticipates beginning patient recruitment in 2025.
The manufacturing milestone marks a significant step in advancing linaprazan glurate towards potential market approval. The IMP was produced by Lonza, a global contract development and manufacturing organization (CDMO), at its facility in Florida. According to Cinclus Pharma, the batch size is representative of commercial-scale production, securing future commercial manufacturing capabilities.
Development of Linaprazan Glurate
Linaprazan glurate is a prodrug of linaprazan, a P-CAB originally developed by AstraZeneca. It is designed to offer rapid and sustained control of intragastric pH, potentially providing more effective relief from GERD symptoms and improved healing of esophageal erosions compared to proton pump inhibitors (PPIs). Over 3,000 individuals have been exposed to linaprazan or linaprazan glurate in more than 30 Phase I and two Phase II studies.
The Need for New GERD Treatments
Gastroesophageal reflux disease (GERD) affects approximately 133 million adults in the US and EU-30, resulting in symptoms such as acid reflux and heartburn. While proton pump inhibitors (PPIs) dominate the market, a significant portion of patients with severe erosive GERD (eGERD), estimated at 10 million in the EU and US, do not achieve adequate relief with current standard treatments. Linaprazan glurate is being developed to address this unmet need by providing more effective acid control.
Clinical Development Plan
Cinclus Pharma is advancing its Phase III program for linaprazan glurate, with the study start expected in 2025. The company aims to demonstrate the drug's ability to heal esophageal erosions and alleviate GERD symptoms more effectively than existing therapies.
"This is the first time we are manufacturing our new formulation on a large scale, which is an important milestone to be able to start our phase III studies, especially given that it is a new formulation that has not been manufactured on a large scale before. Today's announcement bodes well for the future as the batch size is representative of a commercial batch and secures the coming commercial manufacturing. This also means that we are on track to be able to recruit the first patient in 2025," said Christer Ahlberg, CEO of Cinclus Pharma.
