Cinclus Pharma: New scientific article highlights rapid and sustained acid control with linaprazan glurate
Cinclus Pharma Holding AB (publ), a clinical-stage pharmaceutical company developing next-generation treatments for acid-related diseases, announces the publication of results from two Phase 1-studies of linaprazan glurate in Alimentary Pharmacology & Therapeutics. The data in these studies demonstrates rapid and sustained acid control with close to 100% pH control at the highest dose levels.
“These Phase 1-results show rapid and sustained acid control with linaprazan glurate. The dose-response in pH-control and good tolerability observed in these studies support its continued clinical development for patients with erosive GERD,” says Kajsa Larsson, Chief Medical Officer of Cinclus Pharma.
About the studies
The publication describes two open-label Phase 1 studies in Slovenia. In one study, 73 healthy adults received 25 mg, 50 mg or 75 mg of linaprazan glurate once or twice daily for 14 days. Stomach pH and blood levels of linaprazan glurate and its active metabolite, linaprazan, were measured after the first dose and after repeated doses.
In the second study, 67 healthy adults received a single dose of each tablet formulation in a randomized crossover design. The study compared the bioavailability of the new tablet formulation with that of the tablet formulation used in previous studies and assessed the effect of a high-fat meal on the new formulation. The results showed that the new formulation that was used in the Phase III study provided approximately twice the bioavailability of the previously used formulation.
Both studies are registered on ClinicalTrials.gov as NCT05627518 and NCT05742984.
Article information
Authors: Kajsa Larsson, Kjell Andersson, Gunilla Huledal, Jouni Junnila, Kristofer Katkits Nilsson, Elham Yektaei, Matjaž Fležar and Peter Unge
Journal: Alimentary Pharmacology & Therapeutics
To access the article, please click the following link: http://doi.org/10.1111/apt.70980
For additional information, please contact:
Christer Ahlberg, CEO
Phone: +46 70 675 33 30
e-mail: christer.ahlberg@cincluspharma.com
Henrik Vikström, IR
Phone: +46 70 952 80 06
e-mail: henrik.vikström@cincluspharma.com
About Cinclus Pharma
Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. The first Phase III study commenced in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com.