– Conducted under U.S. FDA-cleared IND
– Plans for Phase 2 initiation in Q3 2025 and expansion into Peyronie’s disease
SEOUL, South Korea, May 7, 2025 /PRNewswire/ — Connext, a clinical stage biotechnology company, announced the successful completion of the dose escalation (Phase 1) part of its Phase 1/2 clinical trial for CNT201, its recombinant collagenase therapeutic for Dupuytren’s contracture. The trial was conducted in an open-label format and confirmed both the safety and efficacy of CNT201: no dose-limiting toxicities were observed, and clear therapeutic benefits were demonstrated.
Key Clinical Results and Future Plans
- The study was conducted under a U.S. FDA-approved IND, using an open-label design to evaluate safety, tolerability, efficacy, pharmacokinetics, and immunogenicity.
- The dose expansion (Phase 2) part is scheduled to begin in Q3 2025 as a double-blind study, aiming to demonstrate statistically significant efficacy.
- Top-line data for the entire Phase 1/2 trial are expected in the first half of 2026, with plans to initiate global Phase 3 development in 2027.
- The latest clinical development of CNT201 will be officially presented at the “International Conference on Dupuytren Disease and Related Diseases” in Brussels in May 2025.
Differentiation Through Innovative Recombinant Collagenase
Currently, Endo’s Xiaflex is the only commercially available collagenase injection for Dupuytren’s contracture. CNT201 is being developed as an alternative to Xiaflex and is expected to significantly improve patient access to non-surgical treatment. Collagenase is originally produced by fermentation of the pathogenic microorganism Clostridium histolyticum, which carries inherent risks of contamination with various toxins. In contrast, CNT201 is the world’s first recombinant collagenase therapeutic developed using genetic engineering technology, eliminating the risk of contamination from toxins or animal-derived substances. This ensures superior quality, consistent efficacy, and differentiated safety profiles.
Expanding Indications and Accelerating Global Drug Development
Connext is also pursuing a Phase 2 IND for Peyronie’s disease, based on the same mechanism of action, and aims to obtain U.S. FDA IND clearance in 2025. Additional development for aesthetic indications such as cellulite is also underway.
Statement from Woo Jong Lee, CEO of Connext
“By confirming both safety and efficacy in the dose escalation part of Phase 1/2 study, CNT201 offers a new non-surgical treatment option for patients with Dupuytren’s contracture. We aim to complete global new drug development with Phase 3 entry in 2027 and demonstrate the unique advantages of our innovative recombinant therapeutic,” said Woo Jong Lee, CEO of Connext.
Contact:
Sangho Lee, Head of Innovation
[email protected]
