Cinclus Pharma has announced an agreement with the U.S. Food and Drug Administration (FDA) regarding its initial Pediatric Study Plan (iPSP) for linaprazan glurate. This agreement is a regulatory prerequisite for market approval of linaprazan glurate, a drug aimed at treating acid-related diseases, in adult patients. Furthermore, it opens the possibility of expanding the drug's approval for use in children.
Christer Ahlberg, CEO of Cinclus Pharma, stated, "The agreement on our pediatric study plan with the FDA is a prerequisite for market approval in the US, so it’s really a milestone... Furthermore, an approved pediatric indication would significantly increase the target population for linaprazan glurate."
Pediatric Study Plan Details
The agreed iPSP primarily involves a clinical efficacy and safety trial. This trial will include approximately 100 pediatric patients who will receive linaprazan glurate following the same treatment schedule as used in the company's Phase III trials for adult patients with erosive gastroesophageal reflux disease (eGERD). The study plan closely mirrors the agreement recently reached with the European Medicines Agency (EMA) Pediatric Committee (PDCO).
Regulatory Context
A regulatory agreement on a pediatric study plan is mandatory before a sponsor can submit a Marketing Authorization Application for commercializing a new medicine for adult patients. Cinclus Pharma submitted its proposed iPSP to the FDA in December 2023 and has since been navigating the regulatory review process. The agreed iPSP includes a deferral, allowing the pediatric efficacy and safety trial to be conducted after the Marketing Authorization Application has been submitted.
About Linaprazan Glurate
Linaprazan glurate, a prodrug of P-CAB linaprazan initially developed by AstraZeneca, is Cinclus Pharma's leading drug candidate. It is designed for treating acid-related diseases and disorders of the upper gastrointestinal tract. Linaprazan glurate aims to more effectively heal erosions in the esophageal mucosa and alleviate symptoms of gastroesophageal reflux disease (GERD) compared to existing treatments like 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. GERD affects approximately 133 million adults in the US and EU, with about 10 million patients suffering from the most severe forms, highlighting the need for new and improved treatments.
