Onconic Therapeutics: "No Significant Drug-Drug Interactions Found Between Jakubo and Four Cardiovascular Agents"
Clinical Study of Combination Therapy with Clopidogrel, Aspirin, Atorvastatin, and Apixaban
Establishing Evidence Reflecting Real-World Prescription Practices
The 37th domestically developed new drug, Jakubo, has established clinical evidence for combination therapy with cardiovascular agents.
On July 14, Onconic Therapeutics announced through a regulatory filing that it evaluated drug-drug interactions (DDI) by administering Jakubo repeatedly alongside clopidogrel, aspirin, atorvastatin, and apixaban and found no clinically significant interactions.
This clinical trial was conducted in healthy adults to assess the drug-drug interactions between Jakubo and commonly co-prescribed cardiovascular medications in real-world prescribing scenarios. The clinical trial was led by Professor Shin Wonseok of the Clinical Pharmacology Department at Bundang CHA Hospital. Patients with gastroesophageal reflux disease often have chronic conditions such as cardiovascular disease or dyslipidemia and thus take multiple medications concurrently. Therefore, clinical evidence regarding combination therapy is a crucial criterion in real-world prescription decisions.
The study showed that when Jakubo was co-administered with clopidogrel, the antiplatelet pharmacodynamic response was similar to clopidogrel alone, confirming that no clinically significant interaction occurred. Similarly, pharmacokinetic and pharmacodynamic evaluations in combination studies with aspirin, atorvastatin, and apixaban demonstrated that there were no meaningful interactions. The safety assessment also reported no serious adverse events or significant drug-related adverse reactions.
As a result, Jakubo now has clinical data confirming that there are no drug-drug interactions with the four cardiovascular agents commonly co-prescribed in actual practice, providing clinicians with clinical evidence to support combination therapy.
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A representative from Onconic Therapeutics stated, "It is significant that we have established clinical evidence confirming that there are no drug-drug interactions between Jakubo and cardiovascular medications for patients with both gastroesophageal reflux disease and cardiovascular conditions, thereby offering new treatment options for healthcare providers. We will continue to accumulate evidence that enhances Jakubo’s clinical utility, thereby expanding therapeutic options for patients."
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