HK inno.N’s K-Cab (tegoprazan), a treatment for gastroesophageal reflux disease (GERD), is more effective in reducing night-time gastric acid than not only an existing proton pump inhibitor (PPI) but another potassium-competitive acid blocker (P-CAB), a study said.

The company plans to use the study results to expand K-Cab’s indications and enhance the drug’s market position.

On Feb. 10, the British Journal of Clinical Pharmacology published the study titled, “Night-time gastric acid suppression by tegoprazan compared to vonoprazan or esomeprazole.”

The study, conducted at the Seoul National University Hospital, evaluated the night-time gastric acid suppression of three drugs -- HK inno.N’s K-Cab, AstraZeneca’s PPI Nexium, and Takeda Pharmaceutical’s world’s first P-CAB Takecab.

The research team recruited 16 healthy adult men (6 CYP2C19 extensive metabolizers (EM), five intermediate metabolizers (IM), five poor metabolizers(PM)). They defined the hours between 10 p.m. and 10 a.m. as nighttime and measured intragastric pH for 12 hours. Reaching intragastric pH 4 was deemed as gastric acid suppression.

The results showed that tegoprazan 50mg suppressed gastric acid more rapidly than vonoprazan 20mg and esomeprazole 40mg.

The increased intragastric pH was maintained stably during the nighttime.

Also, night-time acid suppression by tegoprazan 50mg and vonoprazan 20mg was not dependent on CYP2C19 phenotypes. While the suppression by esomeprazole tended to be influenced by CYP2C19 phenotypes, it was not statistically significant. In this order, Esomeprazole 40mg’s night-time pharmacodynamics increased in EM, IM, and PM groups.

In terms of safety, serum gastrin levels increased after dosing all three drugs, but they were not clinically significant and recovered to their baselines.

The research team said the findings demonstrated that the night-time acid inhibition effect was higher in P-CAB drugs tegoprazan 50mg and vonoprazan 20mg than esomeprazole 40mg, and single dosing was sufficient.

Citing the time to reaching intragastric pH 4, the faster effect of tegoprazan can be a favorable feature in GERD therapy, the research team added.

HK inno.N said the study outcome was encouraging.

“The monitoring of pH levels to compare night-time acid suppression has not been conducted in PPI studies so far. This is because if you compare same class drugs, you have no choice but to see a negative result,” said Song Geun-seok, head of R&D at HK Inno.N, emphasizing the superiority of P-CAB agents.

This study supports that K-Cab can induce an immediate therapeutic effect, regardless of day or night time, he added.

Song went on to say that the company conducted a comparative phase 4 study comparing K-Cab with Nexium, and the study results will be released in the second quarter.

According to Song, the company has applied for K-Cab’s additional indication for maintenance therapy after announcing the phase 3 results late last year. “With this progress, K-Cab will be able to establish its leading position not only in Korea but overseas,” he said.