Onconic presents latest Phase III Jaqbo data in erosive esophagitis

2024-05-29

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临床结果临床3期上市批准

Onconic Therapeutics announced on Wednesday that Jaqbo (zastaprazan citrate) demonstrated efficacy and safety in a Phase III study of patients with erosive esophagitis. The results on the next-generation potassium competitive blocker (P-CAB) were presented at Digestive Disease Week (DDW).

"We are hopeful that Jaqbo can improve patient care globally by providing rapid and sustained relief from symptoms, and we are committed to pursuing its development for broader international markets," said CEO John Kim. Jaqbo was approved for the treatment of erosive esophagitis by the Ministry of Food and Drug Safety (MFDS) of Korea in April.

The ZERO-1 trial compared the efficacy and safety of Jaqbo to AstraZeneca's Nexium (esomeprazole) in 300 patients with erosive esophagitis. Participants received either Jaqbo or Nexium daily for up to eight weeks.

Non-inferior to Nexium

At week eight, the cumulative healing rate was 97.9% in the Jaqbo group and 94.9% in the Nexium group. By week four, the respective healing rates were 95.1% and 87.7%, representing a statistically significant difference. The results confirm that Jaqbo is non-inferior to Nexium.

Additionally, Jaqbo showed a "rapid onset of action within one hour and maintained a gastric pH above four for 85% of the 24-hour period, highlighting its potential to effectively alleviate nighttime acid reflux symptoms with its long-lasting efficacy," the company said.

In 2023, Jaqbo was licensed to China's Livzon Pharmaceutical Group Livzon Pharmaceutical Group for development and commercialisation in the Greater China market.

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