Ascendia Pharmaceuticals awarded new patent on its ASD-002 program for acute coronary syndrome

A ready-to-use, stable and soluble, parenteral form of clopidogrel is feasible using the company's nanoemulsion platform technology.

Clopidogrel, a popular blood thinner medicine, has never been successfully developed in an injectable dosage form due to its inherent chemical instability and poor solubility. “There is a significant unmet medical need for a parenteral clopidogrel dosage form for the treatment of Acute Coronary Syndrome under life-threatening situations,” said Jingjun “Jim” Huang, CEO of Ascendia. “With our nanoemulsion platform technology, Ascendia has demonstrated that a ready-to-use, stable and soluble, parenteral form of clopidogrel is both technically and commercially feasible.” When a patient presents with a suspected coronary event, a high oral dose of clopidogrel is frequently administered as the only available forms of clopidogrel are tablets - not ideal in an emergency setting. Also, when delivered orally, there is a significant delay in the time required for the medicine to become fully absorbed and effective.

ASD-002 can be administered as a single high-dose injection of clopidogrel, capable of overcoming CYP2C19 resistance in a percutaneous coronary intervention (PCI) setting (which 30% of patients experience). Thus ASD-002 will address the unmet need for rapid platelet inhibition, while reducing bleeding risk, associated with newer P2Y12 agents, and has the potential to expand the $2 billion PCI market in peripheral artery disease. ASD-002 for injection also has the potential to provide an advantage compared with the recently approved IV anti-thrombotic drug cangrelor, as ASD-002 should not have an indication exclusion for patients currently on a P2Y12 inhibitor.