The company reached the milestone when the last patient completed the final safety follow-up visit, four weeks after the end of the treatment period. The eight-week treatment period was completed in September, and the dataset will now be prepared for the topline readout.

Linaprazan glurate is a next-generation potassium-competitive acid blocker (PCAB). In the Phase II LEED study, patients with moderate to severe erosive GERD reached four-week healing rates of up to 93% with linaprazan glurate, compared with 38% for lansoprazole.

Standard proton pump inhibitor (PPI) therapy fails to heal a significant proportion of patients with the most severe forms of erosive GERD, a substantial unmet medical need among an estimated 19 million patients worldwide.

Positive topline results would be a key step toward regulatory submission and commercialization in Europe, through the licensing agreement with Zentiva, and in the US, where Cinclus Pharma retains full commercial rights. A second Phase III study, HEEALING2, will evaluate maintenance therapy as required by both the FDA and the EMA. It is planned to start in the US and Europe after the HEEALING1 readout.

“Many patients with severe erosive GERD do not achieve complete healing with current treatments. We believe linaprazan glurate has the potential to offer a better option for these patients,” says Christer Ahlberg, CEO, Cinclus Pharma. “With all planned patient visits in HEEALING1 now complete, we remain on track to report topline results in Q4 2026.”