Groundbreaking Phase-3 Results for New Heartburn Medication Unveiled

Introduction to JAQBO and the ZERO-1 Study

Onconic Therapeutics, a leading biopharmaceutical company, announced the promising results of its Phase-3 study of JAQBO (Zastaprazan-Citrate) during the Digestive Disease Week (DDW) 2024 in Washington D.C. The study, named ZERO-1, focused on treating erosive esophagitis, a condition caused by chronic acid reflux.

Study Design and Methodology

The ZERO-1 study was a randomized, double-blind, active-controlled trial involving 300 patients diagnosed with erosive esophagitis. The participants were divided into two groups: one receiving 20 mg of Zastaprazan daily and the other receiving 40 mg of Esomeprazol daily for up to eight weeks.

This study aimed to compare the effectiveness and safety of Zastaprazan with Esomeprazol, a commonly prescribed medication for the condition. Measurements included the healing rate of esophageal lesions and the onset of action in relieving symptoms.

Study Results and Key Findings

The results were significant. By week 8, 97.9% of patients treated with Zastaprazan showed healed esophageal tissues, compared to 94.9% of those treated with Esomeprazol. By week 4, the healing rates were 95.1% for Zastaprazan versus 87.7% for Esomeprazol, a statistically significant difference.

Furthermore, Zastaprazan demonstrated a rapid onset of action, providing relief within one hour and maintaining the stomach's pH level above 4 for 85% of the 24-hour period. This suggests its potential to offer sustained relief from acid reflux symptoms, particularly during nighttime.

Implications for Patient Care

John Kim, Ph.D., CEO of Onconic Therapeutics, expressed enthusiasm for the study's results. He emphasized that the effectiveness and safety of JAQBO could significantly improve patient care by offering quick and long-lasting symptom relief.

Dr. Jung-hwan Oh, the lead study author and gastroenterologist at Eunpyeong St. Mary's Hospital in Korea, highlighted that Zastaprazan's rapid action and sustained efficacy make it a promising treatment option for patients with erosive esophagitis, potentially reducing the burden of chronic acid reflux.

Future Prospects and Market Expansion

Following the successful study results, JAQBO received approval from the Korean Ministry of Food and Drug Safety (MFDS) for treating erosive esophagitis. This milestone marks an essential step in bringing this innovative treatment to patients in Korea and beyond.

Looking ahead, Onconic Therapeutics aims to expand JAQBO's availability worldwide. In March 2023, they partnered with Livzon Pharmaceutical Group to develop and market the drug in China. This collaboration is expected to pave the way for wider international distribution and access.

Conclusion

The ZERO-1 study underscores Zastaprazan's potential as an effective treatment for erosive esophagitis, offering superior healing rates and quicker onset of relief compared to existing therapies. With regulatory approvals and strategic partnerships, Onconic Therapeutics is poised to make a significant impact on patient outcomes globally.