Cinclus Pharma, a pharmaceutical company focused on acid-related disease treatments, 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 significant advancement in the drug's development pathway, potentially paving the way for its approval and use in both adult and pediatric populations.
The PIP outlines the strategy for studying linaprazan glurate in children, a necessary step for securing marketing authorization in the European Union for new medicines intended for adult use. 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."
Clinical Trial Details
The agreed PIP primarily involves a clinical efficacy and safety trial. This trial will enroll approximately 100 pediatric patients who will receive linaprazan glurate following the same treatment schedule as employed in the company's Phase III trials involving adult patients with erosive gastroesophageal reflux disease (eGERD). The study aims to evaluate the drug's effectiveness and safety profile in this younger population.
Regulatory Implications
According to regulatory guidelines, any new medicine developed for adult patients must also be evaluated for potential pediatric applications. This involves creating a comprehensive plan to determine the specific disease stage or form to be treated, adjusting the dosage and administration methods to suit pediatric physiology, and assessing the medicine's safety and efficacy in pediatric patients.
Next Steps
Cinclus Pharma submitted its proposed PIP to the EMA in December 2023 and has since been undergoing regulatory review. The agreed PIP includes a deferral, meaning that the pediatric efficacy and safety trial is expected to begin after the Marketing Authorization Application has been submitted. An approved pediatric indication would significantly expand the potential patient population for linaprazan glurate.
