Last Patient Out (LPO) from the Phase II study of linaprazan glurate

Cinclus Last Patient

We are working hard to get the top-line data in place as soon as possible to be presented during the fall. We are already looking forward to it!

The Phase II study was initiated in H2 2021 within a de-risked clinical development program. The scope of the test is: to select the optimal dose for the phase III studies, based on dose dependent healing rates of erosive esophagitis.

The program is based on precedent trials on the active metabolite of linaprazan glurate and includes ~2,500 subjects, showing that linaprazan glurate is an excellent biomarker with linear correlation between plasma concentration and acid control.

 

The primary objective of the Phase II study is to support dose selection of linaprazan glurate for Phase III studies based on four weeks healing of esophagitis. The secondary objective is to evaluate the safety and tolerability of linaprazan glurate compared to standard PPI, to compare the symptom response after four weeks with three dose levels of linaprazan glurate compared to standard PPI and to model the optimal dose of linaprazan glurate using healing rates and PK data in patients treated with linaprazan glurate.The study is a multi-center, randomized, double-blind, active comparator-controlled, parallel group design study with four arms conducted in patients with reflux esophagitis grade C and D and patients still unhealed after four weeks standard treatment healing course with PPI.


Endpoints

  • The primary endpoint is the healing rates of eGERD after four weeks treatment
  • Evaluate the safety and tolerability of linaprazan glurate
  • Symptom response during and after four weeks
  • Model the optimal dose of linaprazan glurate for phase 


Number of patients

  • At least 200 evaluable patients
  • Approximately 60 sites
  • Approximately 10 countries in Europe and US

 

Learn more about our science