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Daewoong Pharmaceutical’s press release

Daewoong Pharmaceutical Announces Publication of Novel P-CAB Fexuprazan Phase 1 Bridging Study

No.: 346
Views: 391

2020-1106

Daewoong Pharmaceutical Announces Publication of Novel P-CAB Fexuprazan Phase 1 Bridging Study

- Bridging study results, published in the SCI journal, AP&T, demostrate no racial differences exist in pharmacokinetic and pharmacodynamic properties of fexuprazan
- Fexuprazan aims to be the best-in-class drug for gastroesophageal reflux disease with outstanding Phase 3 study results

On October 27, the bridging study results on Fexuprazan, developed by the Korean pharmaceutical company, Daewoong Pharmaceutical (Daewoong; CEO Sengho Jeon), was published in the SCI medical journal Alimentary Pharmacology and Therapeutics (AP&T). Fexuprazan is a potassium-competitive acid blocker (P-CAB), which reversibly blocks the proton pump that secretes gastric acids from the stomach wall. It is a novel drug investigated for gastroesophageal reflux disease.

The bridging study assessed pharmacokinetic and pharmacodynamic profiles of Fexuprazan in healthy Korean, Caucasian, and Japanese adults at the Seoul National University Hospital. In this study, Daewoong examined the drug blood concentrations and inhibitory effect on gastric acid secretion after single and repeated dosing, which showed no pharmacokinetic and pharmacodynamic differences exist between the races. The International Conference on Harmonisation (ICH) guideline recommends evaluation of pharmacokinetics and pharmacodynamics in order to extrapolate the data obtained in one region to another.

CEO Sengho Jeon at Daewoong said, “We are seeking to diversify dosage forms and conduct clinical studies for additional indications to establish Fexuprazan as a best-in-class drug among other gastroesophageal reflux disease treatments based on our differentiated and outstanding symptom data. These study results are expected to accelerate our partnership efforts to quickly commercialize Fexuprazan in global markets, including the US and Europe.”

Meanwhile, Daewoong’s Fexuprazan Phase 3 study results in Korean patients with erosive gastroesophageal reflux disease, has also been selected and published as a top 10% poster in 2020 Digestive Disease Week (DDW). The study results showed that Fexuprazan has 99% cure rate after 8 weeks of treatment and confirmed it is well-tolerate. Additionally, Fexuprazan provided effective and immediate relief of heartburn symptoms that occur both day and nighttime. When administered to patients with modrate to severe symptoms, the symptom improvement was three times greater than those administered with a proton pump inhibitor.

Furthermore, Daewoong recently obtained Investigational New Drug (IND) approval from the Korean Ministry of Food and Drug Safety (MFDS) to conduct investigation of Fexuprazan as an injection formulation, which is intended for patients who have difficulties in taking drug orally or require quick inhibition of gastric acid secretion.

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