Cinclus Pharma Holding AB (publ), a clinical pharmaceutical company developing next-generation treatments for acid-related diseases, announces today that the last patient in the Phase III HEEALING1 study will complete the eight-week treatment period today, marking a significant step toward the Q4 2026 topline readout.
Following completion of the treatment period, all patients will undergo a four-week safety follow-up visit, after which the dataset will be prepared for the Q4 2026 readout.
"Completing the treatment period in HEEALING1 is a meaningful clinical milestone. All patients have now gone through the full eight-week treatment course, and we have strong confidence in the quality and integrity of the data we will be reporting in the fourth quarter," said Kajsa Larsson, Chief Medical Officer of Cinclus Pharma.
Linaprazan glurate is a next-generation potassium-competitive acid blocker (PCAB) that demonstrated strong efficacy in the Phase II LEED study. In LEED, patients with moderate to severe erosive GERD achieved with linaprazan glurate four-week healing rates of up to 93% compared to 38% for lansoprazole.
Standard proton pump inhibitor (PPI) therapy fails to heal a significant proportion of the most severe patients, representing a substantial unmet medical need across an estimated 19 million patients worldwide.
Positive topline results would represent a key step toward regulatory submission, supporting commercialization in Europe through the licensing agreement with Zentiva and in the US, where Cinclus Pharma currently retains full commercial rights. The company's second Phase III study, HEEALING2, which will evaluate maintenance therapy as required by both the FDA and EMA, is planned to commence in both the US and Europe following the HEEALING1 topline readout.
"With the treatment period now complete, we are on a clear and defined path to our topline readout. HEEALING1 has executed on schedule throughout, and we remain fully on track for Q4 2026. The unmet need in severe erosive GERD is well-documented, and we believe linaprazan glurate has the potential to change the standard of care for patients who have not been well served by current options," said Christer Ahlberg, CEO of Cinclus Pharma.
About the HEEALING1 Study
The pivotal HEEALING1 study is designed to confirm the efficacy of linaprazan glurate in patients with erosive GERD. The randomized, double-blind trial compares linaprazan glurate to the current standard of care, a proton pump inhibitor (PPI), with primary focus on superior healing rates, faster healing time, and improved symptom control. The trial includes 523 patients in eight European countries. The primary endpoint is superiority to the proton pump inhibitor lansoprazole in healing of patients with moderate to severe erosive GERD (LA grade C/D) after 4 weeks. Secondary endpoints will include healing and symptom relief for up to 8 weeks.
About Linaprazan Glurate
Linaprazan glurate is a next generation of potassium competitive acid blockers (PCAB) with a unique acid control inhibiting profile that enables enhanced healing and symptom relief in patients with severe forms of acid-related diseases. It is a prodrug of linaprazan, designed to optimize pharmacokinetics by providing sustained acid suppression with lower peak plasma concentrations.
Phase II data for linaprazan glurate has demonstrated robust healing efficacy, particularly in patients with severe erosive GERD. In the randomized, double-blind LEED study, linaprazan glurate achieved healing rates of up to 93% at four weeks in patients with LA grade C/D disease, compared to just 38% for lansoprazole. In patients with only partial response after 8 weeks of PPI treatment linaprazan glurate showed 100% healing after 4 weeks of treatment in the best dosing group.
About Erosive GERD
Erosive GERD is a severe form of GERD characterized by visible erosions or ulcerations in the esophageal lining, typically confirmed via endoscopy. Severity is graded from A to D using the Los Angeles Classification system, with grades C and D representing the most extensive mucosal injury.
Patients with severe erosive GERD often experience more persistent symptoms, slower healing, and a reduced response to conventional PPI therapy, with a substantial proportion failing to achieve complete healing. This population represents a significant unmet medical need, with an estimated 19 million patients affected globally, including over 10 million in Europe and the US. In patients with LA grade C/D disease, healing rates with PPIs at four weeks can be as low as 30-40%, underscoring the need for more effective treatment options.
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.
