Clinical Trial: Dose-Finding Study of Linaprazan Glurate, A Novel Potassium-Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis

IF 6.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Prateek Sharma, Michael Vaezi, Peter Unge, Kjell Andersson, Kajsa Larsson, Ivan Popadiyn, Maria Rosenholm, Andras Rosztóczy, Elham Yektaei, David Armstrong
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引用次数: 0

Abstract

Background

Linaprazan glurate, a potassium-competitive acid blocker, is in development for the treatment of erosive oesophagitis and other acid-related diseases.

Aim

To evaluate the 4-week healing rate and safety of four linaprazan glurate dosing regimens in patients with erosive oesophagitis.

Methods

This double-blind, dose-finding study compared linaprazan glurate to lansoprazole. We included patients with endoscopically confirmed erosive oesophagitis (validated by a central review board) if they had Los Angeles (LA) grade C/D or LA grade A/B with partial response to at least 8 weeks of proton pump inhibitor therapy. Patients were randomised to 4 weeks of linaprazan glurate (25, 50, 75 or 100 mg twice daily) or lansoprazole (30 mg once daily), followed by 4 weeks of open-label lansoprazole.

Results

Of 248 patients randomised, central review confirmed erosive oesophagitis in 182 at screening endoscopy. Across all doses, linaprazan glurate achieved a 4-week healing rate of 71.1% in intention-to-treat (ITT) analysis and 80.9% in per protocol (PP) analysis. In comparison, lansoprazole achieved healing rates of 60.6% (ITT) and 59.1% (PPS). The best performing linaprazan glurate dosing group outperformed lansoprazole by 28% in patients with LA grade A/B with partial PPI response and by more than 50% in patients with LA grade C/D.

Conclusions

Linaprazan glurate demonstrated high 4-week healing rates compared to lansoprazole, with a good safety profile, supporting its further development.

Trial Registration

ClinicalTrials.gov: NCT05055128; EudraCT: 2020-003319-91

Abstract Image

Abstract Image

临床试验:一种新型的钾竞争性酸阻滞剂——谷氨酸利纳帕赞与兰索拉唑治疗糜烂性食管炎的剂量对比研究
glurate Linaprazan是一种钾竞争性酸阻滞剂,正在开发用于治疗糜烂性食管炎和其他酸相关疾病。
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来源期刊
CiteScore
15.60
自引率
7.90%
发文量
527
审稿时长
3-6 weeks
期刊介绍: Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.
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