Kvartalsrapport Q4 2026

Fulltext

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PRESS RELEASE
02 July 2026 08:00:00 CEST
    Cinclus Pharma Holding AB (publ) Kungsbron 1 111 22 Stockholm• •
CINCLUS PHARMA HAS REACHED ENROLLMENT 
TARGET IN PHASE III HEEALING1 STUDY – TOPLINE 
RESULTS EXPECTED Q4 2026
Cinclus Pharma Holding AB (publ), a clinical pharmaceutical company 
developing next-generation treatments for acid-related diseases, today 
announced that the randomization target has been reached in HEEALING1, the 
company's pivotal Phase III study evaluating linaprazan glurate for the 
treatment of erosive gastroesophageal reflux disease (GERD).
HEEALING1 is a randomized, double-blind study that has, as of today, randomized 521 
patients, exceeding the protocol-specified target of 501 patients. A few additional patients 
are currently in screening and are expected to be randomized over the coming days. The 
primary endpoint is superiority to lansoprazole in healing of moderate to severe erosive 
GERD (LA grade C/D) after four weeks, with secondary endpoints assessing healing and 
symptom relief at up to eight weeks of treatment.
Linaprazan glurate is a next-generation potassium-competitive acid blocker (PCAB) that 
demonstrated strong efficacy in the Phase II LEED study. In patients with moderate to severe 
erosive GERD, linaprazan glurate achieved 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.
"Reaching the enrollment target in HEEALING1 is an important step for our program and for 
the more severe GERD-patients who currently have few effective treatment options. The 
study is designed to confirm in a large, well-powered population what our Phase II data have 
already shown, and we look forward to reporting those results later this year," said Kajsa 
Larsson, Chief Medical Officer of Cinclus Pharma.
"The completion of enrollment in HEEALING1 represents an important operational 
achievement for Cinclus Pharma and keeps us on track to report topline results in Q4 2026. 
Severe erosive GERD remains an area of significant unmet medical need, and we believe 
linaprazan glurate has the potential to meaningfully improve treatment outcomes. As we 
now turn our focus to study completion and data readout, we look forward to the next stage 
in the program's development," said Christer Ahlberg, Chief Executive Officer of Cinclus 
Pharma.
The company's second and final Phase III study for the main indication erosive GERD, 
HEEALING2, will also evaluate maintenance therapy and is planned to commence in both the 
US and Europe following the HEEALING1 topline readout.

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PRESS RELEASE
02 July 2026 08:00:00 CEST
    Cinclus Pharma Holding AB (publ) Kungsbron 1 111 22 Stockholm• •
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 has 
randomized 521 patients in eight European countries. Participants undergo an eight-week 
treatment period. 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.
 
Top-line results from the HEEALING1 study are expected in Q4 2026. The second healing 
study, HEEALING2, that will also evaluate maintenance therapy is planned to commence in 
both the US and Europe following the topline results of HEEALING1.
 
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 have 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. 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.

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PRESS RELEASE
02 July 2026 08:00:00 CEST
    Cinclus Pharma Holding AB (publ) Kungsbron 1 111 22 Stockholm• •
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
Attachments
Cinclus Pharma has Reached Enrollment Target in Phase III HEEALING1 Study – Topline 
Results Expected Q4 2026