Kajsa Larsson, CMO, on the upcoming Phase III studies of linaprazan glurate
Highlights from the 2024 Annual Report: Interview with Kajsa Larsson.
Cinclus Pharma is preparing to conduct Phase III studies to treat erosive GERD (gastroesophageal reflux disease with erosive changes) in Europe and the United States. In Europe, the study will be made public after approval, while in the US the information will be available through a public study database once the study starts enrolling patients.
”In collaboration with our CRO (Contract Research Organization), we have developed a detailed protocol outlining the study design. The protocol must be approved by regulatory authorities in each participating country and may be adjusted during the process. Additionally, patient information and other documentation have been prepared for translation and review by the ethics authorities or committees in each country.”
For the study, we have identified investigators, clinical sites, and research personnel at various centers where patient visits will take place. These sites will also be able to disseminate information about the study to nearby healthcare facilities, enabling direct contact with patients suffering from erosive GERD.”
The first Phase III study focuses on treating erosive esophagitis, a form of GERD that causes bleeding and painful changes in the esophagus. The objective is to confirm results from the Phase II study, in which linaprazan glurate showed rapid and effective healing of even the most severe forms of erosive GERD.
The study will involve approximately 500 patients from eight countries in Europe and North America, with up to 100 hospitals and clinics participating. About one-third of the patients are expected to have more severe grades of erosive GERD (grades C and D according to the Los Angeles classification).
The study includes a one-month screening period, an eight-week treatment period, and a four-week follow-up to evaluate safety and efficacy.
Two pivotal Phase III studies will be conducted to meet regulatory requirements. These do not have to be identical but must be able to support and confirm each other’s findings. The aim is to demonstrate that linaprazan glurate offers superior healing and symptom relief compared to current standard treatments.
”We are already looking forward to starting the roll-out of the study and, of course, the first read-out. It will be very exciting.”, Kajsa concludes.