Cenyx Biotech has announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for CX213, a novel nanozyme-based therapeutic, paving the way for a Phase 1 clinical trial. This marks a significant step forward in the development of an emergency treatment for subarachnoid hemorrhage (SAH). The trial is scheduled to commence in the first quarter of next year.
CX213 is the first anti-inflammatory emergency treatment based on nanozymes to receive FDA IND approval. It is specifically designed to address severe acute inflammatory conditions, with a primary focus on SAH. The Phase 1 study will evaluate the safety and tolerability of CX213 in healthy adult participants.
Addressing Unmet Needs in SAH Treatment
SAH affects approximately 30,000 individuals in the U.S. and Europe each year, resulting in substantial healthcare costs, estimated at $2.4 billion in the U.S. and $1.77 billion in Europe. Currently, there are no approved emergency treatments for SAH, leaving a significant gap in patient care. Cenyx Biotech believes that CX213, with its innovative mechanism of scavenging excess free radicals, has the potential to offer a new treatment option.
CX213: A Novel Nanozyme-Based Therapeutic
CX213 comprises four key components, including Ceria nanoparticles and biocompatible polymers, and is based on Cenyx Biotech's proprietary InnoSurface platform technology. The drug's design targets the acute inflammatory response associated with SAH, aiming to mitigate the damaging effects of excessive free radicals.
Leadership Perspective
"This FDA phase 1 approval is the first step in our global expansion. We will continue our R&D efforts to position CX213 as a first-in-class treatment," said Cenyx Biotech CEO Lee Seung-hoon. Professor Lee, a Neurology professor at Seoul National University Hospital (SNUH), founded Cenyx Biotech in 2016.
