Press release

Cinclus Pharmas presents positive data on linaprazan glurate at international scientific conference

Cinclus Pharma AB (publ), which develops drugs for the treatment of gastric acid-related diseases, today announced that the company on May 5 presented positive data at the scientific conference Digestive Disease Week in San Diego. The presentations included data on linaprazan glurate's good capacity to inhibit acid production as well as positive data on the optimized tablet formulation developed for the Phase III studies and an upcoming commercialization.

The presentations, titled Pharmacokinetics and Pharmacodynamics of Linaprazan Glurate after Multiple Oral Doses up to 14 Days in Healthy Subjects and Optimized Biopharmaceutical and Pharmacokinetic Properties of a Linaprazan Glurate Tablet Formulation to Be Used in Phase 3, held at the international conference Digestive Disease Week in San Diego were held by Dr Kajsa Larsson, Chief Medical Officer at Cinclus Pharma.

The first presentation showed data on linaprazan glurate's capacity to inhibit hydrochloric acid production in the stomach and keep the degree of acid under very good control. Six different dose levels were studied in healthy subjects during 14 days of treatment. Already after the first dose, a good effect was seen and within 90 minutes, the two highest doses gave continuous acid control with a pH>4.0 in the stomach >90% of the time. At full effect, the two highest doses led to acid control with pH>5.0 more than 80% of the time.

The second presentation showed data on the optimized tablet formulation for linaprazan glurate that has been developed for the Phase III studies and an upcoming commercialization. The new formulation leads to an approximate doubling of the bioavailability compared to the formulation used in previous studies.

"The data we present show that the new linaprazan glurate formulation has very good pharmacokinetic properties and provides both a very rapid and powerful acid inhibition in the stomach. The results are promising for the first Phase III study planned later this year," said Kajsa Larsson, Chief Medical Officer at Cinclus Pharma.

“It is gratifying to present further positive data on linaprazan glurate's ability to inhibit acid production ahead of our Phase III studies and an upcoming commercialization. We see great market potential for the next generation drugs for acid-related diseases that have a unique ability to improve the quality of life for patients with the more severe forms of eGERD," said Christer Ahlberg, CEO of Cinclus Pharma.

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. Planning for phase III studies is currently underway, with an expected start 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.

About DDW
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.