CureGene Pharmaceutical has received approval from China's National Medical Products Administration (NMPA) for its Clinical Trial Application (CTA) for CG-0255 for Injection, a novel antiplatelet drug. This approval allows CureGene to advance the development of CG-0255 in China as a potential new therapeutic option for patients with coronary artery disease (CAD).
CG-0255 is designed as a next-generation P2Y12 receptor antagonist. It has completed Phase I clinical trials in the United States for both intravenous and oral formulations, with positive results presented at the 2023 American Heart Association (AHA) and the 2024 European Society of Cardiology (ESC) annual meetings.
Addressing Coronary Artery Disease
Coronary artery disease is a leading cause of cardiovascular-related mortality, accounting for approximately 10 million deaths worldwide annually. Antiplatelet medications are essential for preventing blood clot formation, reducing the risk of heart attacks and strokes associated with CAD.
The approved CTA for CG-0255 Injection targets patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), including angioplasty. The injectable formulation offers a faster onset of action, enhanced efficacy, and increased bioavailability compared to oral antiplatelet therapies. CG-0255's unique metabolic pathway circumvents challenges related to individual genetic variations in the cytochrome P450 (CYP) 2C19 enzyme system, which can affect the effectiveness of current antiplatelet medications.
CG-0255: A Novel Antiplatelet Therapy
CG-0255 is the world's first thiol prodrug, metabolized by carboxylesterases, bypassing the liver enzyme system for activation. This addresses clinical challenges such as drug resistance, low bioavailability, and the risk of adverse drug interactions. Achieving peak efficacy within 15 minutes, CG-0255 is available in both injectable and oral formulations, providing healthcare professionals with a flexible method for preventing blood clots in various clinical settings.
CureGene's Vision
"This clinical approval represents a remarkable milestone for CG-0255 and validates the dedication and hard work of our team," said Dr. Gongxin He, Founder and CEO of CureGene. "We are eager to progress CG-0255 through its clinical development stages in China and look forward to collaborating with global partners to bring innovative treatments to patients with cardiovascular diseases."
