Linaprazan glurate in the treatment of erosive oesophagitis

A recent study demonstrates the potential of linaprazan glurate, a potassium-competitive acid blocker, in treating moderate to severe erosive oesophagitis. Linaprazan glurate outperformed lansoprazole showing higher healing rates of erosive oesophagitis and demonstrating superior acid control.

A double-blind, randomised, dose-finding study aimed at determining the optimum dose of linaprazan glurate [1]. A total of 248 patients with either moderate (Los Angeles (LA) grade A or B) or severe (LA grade C or D) oesophagitis were randomised to linaprazan glurate (25 mg, 50 mg, 75 mg, or 100 mg twice a day) or lansoprazole (30 mg once a day) for a 4-week double-blind treatment period. After the initial 4 weeks, an endoscopy was performed to assess healing. Subsequently, all patients entered a 4-week open-label treatment period with lansoprazole 30 mg daily, ensuring that each patient received a full 8-week course of therapy.

The primary outcome was the healing rate of erosive oesophagitis. The results indicated a 4-week healing rates of 73.7% (linaprazan glurate 25 mg) up to a maximum of 78.0% (linaprazan glurate 75 mg), which surpassed the healing rates seen with lansoprazole (60.6%). When looking at the per-protocol analysis, the healing rates at 4 weeks peaked at 90.5% for the 75 mg dose compared with 59.1% for lansoprazole.

In the subgroup of patients with severe oesophagitis, a healing rate gradient from 58.3% (linaprazan glurate 25 mg) to 85.0% (linaprazan glurate 75 mg) was seen, dropping to 50.0% for the 100 mg dose. All these percentages were higher than the healing rate of 33.3% with lansoprazole.

Secondary objectives included patient-reported outcomes, particularly the number of heartburn-free days. Across the various doses, the number of heartburn-free days was comparable, although slightly higher for the 100 mg dose. From a safety perspective, no deaths or adverse events of special interest were reported. Overall, the safety profile was comparable to that of lansoprazole.

In conclusion, the healing, symptom control, and safety data support dose selection and further development of linaprazan glurate in phase 3 studies. The drug showed high erosive oesophagitis healing rates and a low symptom burden. Linaprazan glurate was well-tolerated with no dose-related increase in adverse events. The safety profile was on par with lansoprazole.

1. Armstrong D, et al. Linaprazan glurate is highly effective in treating moderate to severe erosive esophagitis: a double-blind, randomized, dose finding study. Lecture 940, DDW 2023, 6–9 May, Chicago, IL, USA.

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Posted on 24 May, 2023