"CureGene Pharmaceutical has received approval from China's National Medical Products Administration (NMPA) for its Clinical Trial Application (CTA) for CG-0255 Benzenesulfonate for Injection.
CG-0255 is the first thiol prodrug of its kind, metabolised by widely expressed carboxylesterases, bypassing the liver enzyme system.
This mechanism helps overcome common challenges such as drug resistance, reduced bioavailability, and adverse interactions. The drug achieves peak efficacy in under 15 minutes and is available in both injectable and oral forms, offering flexibility for various clinical needs.
This investigational antiplatelet drug, classified as a section 1.1 novel drug, marks a significant step forward in the development of CG-0255 in China following notable clinical advancements reported in the United States earlier this year.
Coronary artery disease (CAD), a leading cause of death worldwide, accounts for nearly 10 million fatalities annually. The increasing prevalence of CAD underscores the need for effective treatments to mitigate associated risks, such as heart attacks and strokes.
Antiplatelet therapies play a vital role in reducing these complications by preventing blood clot formation.
CG-0255, developed by CureGene, represents the next generation of antiplatelet therapies as a P2Y12 receptor antagonist. This novel drug, which has both intravenous and oral formulations, features a unique metabolic pathway designed to enhance its efficacy and safety profile.
Phase I clinical trials conducted in the United States demonstrated promising outcomes, with findings presented at major cardiology events, including the 2023 American Heart Association (AHA) and 2024 European Society of Cardiology (ESC) annual meetings.
The approved CTA focuses on the injectable formulation of CG-0255 for patients with acute coronary syndrome (ACS) undergoing procedures like angioplasty. Compared to existing oral therapies, the injectable version offers faster action, improved bioavailability, and greater efficacy.
Moreover, it addresses genetic variations in the cytochrome P450 (CYP) 2C19 enzyme system, a limitation of current antiplatelet treatments, making it an ideal option for emergency care and patients resistant to other therapies.
This latest development positions CG-0255 as a promising option for improving treatment outcomes in cardiovascular care, with potential to address significant gaps in current therapy options.