Daewon Pharmaceutical Prepares to Enter Phase 3 Trials for P-CAB New Drug 'DW4421'

"Plans to Accelerate Research and Development
for Indication Acquisition"

Daewon Pharmaceutical announced on May 12 that it has submitted an application to the Ministry of Food and Drug Safety (MFDS) for approval of a clinical trial plan (IND) to initiate Phase 3 clinical trials for 'DW4421', a treatment currently under development for gastroesophageal reflux disease.

'DW4421' is a treatment that Daewon Pharmaceutical is developing as the fourth domestically produced P-CAB (potassium-competitive acid blocker) new drug. The P-CAB class is attracting significant attention compared to existing PPIs (proton pump inhibitors) because it acts rapidly and can be taken regardless of food intake.

In February, Daewon Pharmaceutical completed a domestic Phase 2 clinical trial for this treatment. The Phase 2 trial was conducted on 147 patients with erosive (mucosal defect) gastroesophageal reflux disease. The subjects were randomly assigned to three groups: 'DW4421 high dose', 'DW4421 low dose', and 'active control drug'. They received oral administration once daily for up to 8 weeks, followed by a 2-week safety follow-up period.

The study results showed that all dosage groups of DW4421 demonstrated higher treatment rates than the active control group in both 'the proportion of subjects with complete healing of mucosal defects', which was the efficacy evaluation criterion, and 'improvement in subjective symptoms (degree of symptom improvement as perceived by the patient)'. Additionally, DW4421 was confirmed to be superior in terms of safety and tolerability.

Accordingly, on April 30, Daewon Pharmaceutical applied to the MFDS for a Phase 3 clinical trial plan. The application includes two studies: 'Evaluation of the efficacy and safety of DW4421 in patients with erosive gastroesophageal reflux disease' and 'Evaluation of the efficacy and safety of DW4421 in patients with non-erosive gastroesophageal reflux disease'.

A Daewon Pharmaceutical official stated, "In this Phase 2 trial, both doses of DW4421 demonstrated higher treatment rates and superior safety and tolerability compared to the control group. With the initiation of Phase 3, we plan to accelerate research and development to obtain indications."

In May last year, Daewon Pharmaceutical signed a contract with Yunovia, a new drug research and development company of the Il-Dong Pharmaceutical Group, for joint development and licensing of P-CAB new drugs. Based on this, Daewon Pharmaceutical has been conducting follow-up clinical trials on the candidate substance (DW4421) identified by Yunovia.

This content was produced with the assistance of AI translation services.