Daewoong tees up phase 3 to expand Fexuclue into erosive GERD maintenance

(Courtesy of Daewoong Pharmaceutical)

Daewoong Pharmaceutical has filed a phase 3 clinical trial application with Korea’s drug regulator to expand the label for its potassium-competitive acid blocker (P-CAB) Fexuclue into maintenance therapy for erosive gastroesophageal reflux disease (GERD), signaling a push to extend the drug’s use beyond acute treatment into relapse prevention.

In a regulatory filing dated last Friday, Daewoong said it submitted an investigational new drug application to the Ministry of Food and Drug Safety for a phase 3 study of Fexuclue 20 mg (fexuprazan hydrochloride) as “maintenance therapy after treatment of erosive GERD.”

The trial will enroll 420 patients with erosive GERD whose healing has been confirmed by upper gastrointestinal endoscopy after drug treatment, and will evaluate efficacy and safety during the maintenance phase.

The multicenter study will use a double-blind, randomized, active-controlled, parallel-group design, followed by an open-label extension. Daewoong said the planned study duration is about 48 months from the date of institutional review board approval.

The primary endpoint is the proportion of patients who maintain endoscopic remission through 24 weeks after receiving the investigational product.

Daewoong said it will first aim to demonstrate non-inferiority versus the comparator on maintenance efficacy and confirm safety, then assess longer-term efficacy and safety in the open-label extension.

Daewoong framed the study as a bid to secure long-term safety data in Korean patients, saying it expects to obtain “long-term safety data in Koreans” for the first time among domestic P-CAB drugs through this program.

The company also pointed to current labeling limits for the 20 mg strength. Daewoong said Fexuclue 20 mg -- unlike the 10 mg and 40 mg doses -- currently carries only an indication for prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers, including gastric and duodenal ulcers.

Daewoong said it plans to pursue a marketing application after completing the study and, if approved, move forward with a launch tied to the expanded indication.