Zydus advances PCSK9 inhibitor with Phase I clinical study approval

Zydus, a global pharmaceutical company, has secured permission from CDSCO, India, to kickstart the Phase I clinical study of its groundbreaking PCSK9 inhibitor. This Phase I study, characterized by its prospective, randomized, double-blind, and placebo-controlled design, is poised to explore the safety and tolerability of the subcutaneously administered anti-PCSK9 product in healthy human volunteers.

Cardiovascular diseases (CVDs) remain the leading global cause of mortality, with approximately 17.9 million individuals succumbing to CVD-related conditions annually, according to the World Health Organization (WHO). Dyslipidemia patients with elevated LDL-C levels face a heightened risk of atherosclerotic cardiovascular disease (ASCVD) events, such as heart attacks and strokes. A PCSK9 inhibitor holds the potential to regulate LDL receptors, responsible for the uptake and clearance of cholesterol from the bloodstream.

Zydus advances PCSK9 inhibitor with Phase I clinical study approval. Photo courtesy of Zydus Cadila.

Pankaj R. Patel, Chairman of Zydus Lifesciences Ltd., shared the company’s vision, stating, “Our aim is to treat Dyslipidemia by inhibiting PCSK9 with a novel entity, which will enhance the removal of LDL-C from the bloodstream and provide patients with a potential for once-in-6-month dosing regimen. We at Zydus are committed to developing novel therapies to address unmet medical needs and are looking forward to the clinical development of our novel anti-PCSK9 product.”

Zydus boasts a dedicated team of 1400 scientists deeply engaged in research and development across five distinct verticals. These verticals focus on the discovery of New Chemical Entities (NCEs), Biologics, Vaccines, Novel Formulations, and Novel API Processes. The innovative Anti-PCSK9 product emerged from the collaborative efforts of the Zydus Innovation Forum, an initiative uniting five different R&D centers of excellence within the company.