Cinclus Pharma Reaches Agreement with EMA on Pediatric Investigation Plan for Linaprazan Glurate
Key Insights
Cinclus Pharma (search) has reached an agreement with the EMA on a Pediatric Investigation Plan (PIP) for linaprazan glurate, a key step for potential marketing approval in the EU.
The PIP includes a clinical efficacy and safety trial involving approximately 100 pediatric patients, mirroring the treatment schedule used in adult Phase III trials.
Agreement on the PIP is a prerequisite for submitting a Marketing Authorization Application for linaprazan glurate for adult patients in the EU.
Cinclus Pharma (search) has announced an agreement with the European Medicines Agency's (EMA) Paediatric Committee (PDCO) regarding the company's Pediatric Investigation Plan (PIP) for linaprazan glurate. This regulatory milestone is a prerequisite for the marketing approval of linaprazan glurate in the European Union for adult patients and opens the door for potential expanded approval for pediatric use.
Significance of the PIP Agreement
The agreement on a PIP with the EMA is a crucial step in the drug development process. It ensures that new medicines are also evaluated for their potential use in children. According to Cinclus Pharma (search), the agreed PIP primarily involves a clinical efficacy and safety trial with approximately 100 pediatric patients. These patients 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).
"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," said Christer Ahlberg, CEO of Cinclus Pharma (search).
Details of the Pediatric Investigation Plan
The PIP outlines the studies required to assess the safety, efficacy, and appropriate dosage of linaprazan glurate in pediatric patients. This includes adapting the drug's formulation and administration for pediatric physiology and evaluating its effects on specific stages or forms of acid-related diseases relevant to children. Cinclus Pharma (search) submitted its proposed PIP to the EMA in December 2023, and the plan includes a deferral, allowing the pediatric efficacy and safety trial to be conducted after the submission of the Marketing Authorization Application (MAA) for adult patients.
About Linaprazan Glurate
Linaprazan glurate is a prodrug of P-CAB linaprazan, initially developed by AstraZeneca. It is being developed by Cinclus Pharma (search) as a potential treatment for acid-related diseases and upper gastrointestinal disorders. The drug has shown potential in healing esophageal erosions and alleviating GERD (search) symptoms more effectively than current treatments like proton pump inhibitors (search) (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. Cinclus Pharma is planning to initiate Phase III studies in 2025.
Market Opportunity
GERD (search) affects approximately 133 million adults in the US and EU, with a significant portion experiencing severe cases that require more effective treatments. Cinclus Pharma (search) aims to address this unmet need with linaprazan glurate, offering a potential improvement over existing therapies.