Onconic Therapeutics Files Phase 3 IND for H. pylori Eradication Indication of Jakubozin (JP-1366) – Expansion of Approved Drug's Label, Limited Short-Term Impact but Positive Long-Term Value
Onconic Therapeutics has submitted a Phase 3 clinical trial plan amendment (IND) to the Ministry of Food and Drug Safety (MFDS) to add an H. pylori eradication indication for its Jakubozin (JP-1366, zastaflazancitrate)-based triple therapy.
This trial aims to expand the label of the already approved domestic new drug No. 37 Jakubozin (20mg), evaluating non-inferiority versus lansoprazole in 414 patients across 22 institutions, including Catholic University of Korea Incheon St. Mary's Hospital, in a multicenter, randomized, double-blind, active-controlled, non-inferiority design.
The study involves 2 weeks of treatment followed by a 13C-UBT test at least 4 weeks post-treatment to confirm eradication. If approved, the trial duration is approximately 24 months.
While the IND application marks entry into Phase 3, the statistical probability of final drug approval is around 10%, so investors should consider clinical failure risk. However, Jakubozin is already approved; gaining this additional indication could extend product life cycle and boost revenue.
[AI Summary]This disclosure is a Phase 3 IND application for label expansion of an already approved drug. Short-term stock price impact is limited, but successful addition of the H. pylori indication would open a new market, enhancing long-term enterprise value. However, investors must account for the ~10% likelihood of final approval.
KOSDAQ Filing Information
Filing: Major Management Matters Related to Investment Decision (Application for Approval of Change in Clinical Trial Plan) (Application for Approval (Change Approval) of Phase 3 Clinical Trial Plan for Evaluating Efficacy and Safety of Triple Therapy Based on Jacuvo (JP-1366) (Zastaprazan Citrate) in Helicobacter pylori Positive Patients)