Patients will now undergo a four-week safety follow-up before the dataset is prepared for the Q4 readout. HEEALING1 enrolled 523 patients across eight European countries, testing whether linaprazan glurate is superior to the proton pump inhibitor lansoprazole in healing rates among patients with moderate to severe erosive GERD (LA grade C or D) after four weeks. The disease affects an estimated 19 million people worldwide, including more than 10 million in Europe and the US, and standard PPI therapy leaves a significant share of the most severe cases unhealed.

“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,” says Christer Ahlberg, CEO, Cinclus.

Linaprazan glurate

Linaprazan glurate is a next-generation potassium-competitive acid blocker and a prodrug of linaprazan, a compound originally developed by AstraZeneca. In the earlier Phase II LEED study, it achieved four-week healing rates of up to 93 percent in patients with severe erosive GERD, compared with 38 percent for lansoprazole. Cinclus has licensed European commercial rights to Zentiva but has retained the US market itself. A positive HEEALING1 readout would support regulatory filings on both sides of the Atlantic and clear the way for a second pivotal trial, HEEALING2, testing maintenance treatment as required by the FDA and EMA.