Oncthetic Therapeutics announced on the 14th through a regulatory filing that its investigational new drug candidate JP-1366 showed no clinically significant drug interactions with major concomitant medications, according to Phase 1 clinical trial results.

This trial was conducted at Bundang CHA Medical Center of CHA University with approval from the Ministry of Food and Drug Safety (MFDS). In healthy adults, the study evaluated the pharmacokinetic and pharmacodynamic interactions and safety when JP-1366 was co-administered separately with clopidogrel, aspirin, atorvastatin, and apixaban. The initial target enrollment was 96 subjects, but 101 were recruited. Excluding five subjects who dropped out prior to dosing, 96 subjects were included in the final analysis.

According to the trial results, no clinically significant pharmacokinetic or pharmacodynamic interactions were observed when JP-1366 was co-administered separately with clopidogrel, aspirin, and atorvastatin. In the case of co-administration with apixaban, the anticoagulant activity (Anti-Factor Xa activity) marker showed a numerical decrease compared to single administration. However, after comprehensively reviewing other pharmacodynamic evaluation results such as PT, PT(INR), and aPTT, it was ultimately assessed that there was no clinically significant interaction.

Through these results, Oncthetic Therapeutics has secured safety and drug interaction data for major concomitant medications. The company plans to actively utilize this data in future patient-targeted clinical trials and the establishment of its regulatory approval strategy. Additionally, the company explained that since the purpose of this trial was not to evaluate therapeutic efficacy but to determine whether interactions occur with other drugs, the absence of significant interactions is a result consistent with the trial's objective.

[Investment Caution] The company urged investors to exercise caution regarding the uncertainties of new drug development. The probability of an investigational clinical drug ultimately receiving regulatory approval as a pharmaceutical product is statistically known to be approximately 10%, and results during the approval process may fall short of expectations. Accordingly, there is a possibility that commercialization plans may be altered or abandoned, and therefore investors should invest prudently by comprehensively considering the investment risks disclosed through regular and ad hoc disclosures and business reports.