Cinclus Pharma announces positive FDA interaction
Cinclus Pharma today announces that the company has completed a successful so-called end-of-phase-II meeting with the US Food and Drug Administration (FDA) for the indication of erosive gastroesophageal reflux disease (eGERD). The FDA broadly accepted Cinclus Pharma's proposal for the phase III program, including study design and the primary endpoint for the studies. The positive outcome allows Cinclus Pharma to proceed with its Phase III program.
"We are very pleased with the outcome of the meeting, which provided us with a clear and feasible regulatory roadmap to approval in the US. We now know what is required of us going forward, which allows us to continue to work on starting up our phase III program and other associated activities as soon as possible. There is a large need for more effective treatment for acid-related gastrointestinal diseases, and we notice that our P-CAB linaprazan glurate is very interesting for gastroenterologists", said Christer Ahlberg, CEO of Cinclus Pharma.