Cinclus Pharma has announced an agreement with the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) regarding its Pediatric Investigation Plan (PIP) for linaprazan glurate. This agreement marks a crucial step in the regulatory pathway for the drug, intended for treating acid-related diseases, and is a prerequisite for securing marketing authorization in the EU.
The agreed PIP outlines a clinical efficacy and safety trial involving approximately 100 pediatric patients. These patients will receive linaprazan glurate following the same treatment schedule as employed in the company’s ongoing Phase III trials for adult patients with erosive gastroesophageal reflux disease (eGERD).
Significance of the PIP Agreement
Securing agreement on a PIP with the EMA is mandatory for any company seeking to commercialize a new medicine for adult patients within the European Union. The PIP ensures that the potential benefits and risks of the new medicine are appropriately investigated for use in children. Christer Ahlberg, CEO of Cinclus Pharma, emphasized the importance of this milestone, stating, "It is incredibly satisfying that our pediatric study plan has been agreed. It is a prerequisite for market approval in the EU, so it’s really a milestone. In addition, an approved pediatric indication would of course also significantly increase our target population."
The agreed PIP includes a deferral, meaning that the pediatric efficacy and safety trial is anticipated to commence after the submission of a Marketing Authorization Application (MAA).
About Linaprazan Glurate
Linaprazan glurate is a prodrug of P-CAB linaprazan, initially developed by AstraZeneca. It is designed to heal erosions in the esophageal mucosa and alleviate symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments, such as proton pump inhibitors (PPIs). Clinical data from over 30 Phase I and two Phase II studies, involving more than 3,000 participants, support the safety and efficacy of linaprazan and linaprazan glurate. Phase III studies are planned to commence in 2025.
Market Opportunity
GERD affects approximately 133 million adults in the US and EU, with a significant portion of these patients, around 10 million, experiencing the most severe forms of the disease. Cinclus Pharma aims to address the unmet need for more effective treatments in this patient population with linaprazan glurate.
