Cinclus Pharma Holding AB ((SE:CINPHA)) announced an update on their ongoing clinical study.
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Study Overview: Cinclus Pharma Holding AB is conducting a Phase 3 clinical trial titled A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Study to Evaluate the Efficacy and Safety of 2 Doses of Linaprazan Glurate Compared to Lansoprazole in 4 or 8 Weeks Healing in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) of Los Angeles (LA) Grades A to D. The study aims to assess the effectiveness and safety of linaprazan glurate in healing erosive esophagitis caused by GERD, compared to the widely used lansoprazole. This research is significant as it could offer a new treatment option for GERD patients.
Intervention/Treatment: The trial tests two doses of linaprazan glurate (50 mg twice daily and 50 mg once daily) against lansoprazole (30 mg once daily). Linaprazan glurate is being evaluated for its potential to heal erosive esophagitis and reduce heartburn symptoms more effectively than lansoprazole.
Study Design: This is a randomized, double-blind, active comparator-controlled study with a parallel intervention model. The primary purpose is treatment, and the study employs quadruple masking to ensure unbiased results. Participants are randomly assigned to one of three groups to receive either linaprazan glurate or lansoprazole.
Study Timeline: The study is not yet recruiting, with an estimated start date in September 2025. The primary completion date is yet to be determined, and the last update was submitted on June 30, 2025. These dates are crucial for tracking the study’s progress and potential market entry of the drug.
Market Implications: The successful outcome of this study could positively impact Cinclus Pharma’s stock performance by introducing a new treatment option in the GERD market, potentially increasing investor interest. Competitors in the GERD treatment space may need to adjust strategies if linaprazan glurate proves more effective than existing options.
The study is ongoing, and further details are available on the ClinicalTrials portal.