World’s First Genetically Recombinant Collagenase Therapeutics (CNT201) Begins Clinical Trials in Australia
SEOUL, South Korea, July 30, 2024 /PRNewswire/ — Connext has announced the successful first administration of CNT201, its therapeutic treatment for Dupuytren’s contracture, in patients.
Dupuytren’s contracture is a debilitating condition characterized by the fibrosis of the fascia between the skin and tendons of the palm due to collagen buildup, causing fingers to become permanently bent and significantly impairing patients’ quality of life. Currently, there is no fundamental cure for this condition. Treatments primarily involve surgical interventions like fasciectomy to alleviate symptoms, although non-surgical methods, such as localized injections of collagenase, have shown high patient satisfaction.
It has received IND approval for Phase 1/2 clinical trials from the U.S. FDA and recently completed the Clinical Trial Notification (CTN) process in Australia. The ongoing clinical trial in Australia represents the Phase 1 part of the Phase 1/2 trial, conducted across three hospitals. The trial involves single administrations of four escalating dose levels in patients with Dupuytren’s contracture, followed by a four-week evaluation period to assess safety, tolerability, efficacy, pharmacokinetics, and immunogenicity. Connext plans to secure proof-of-concept (PoC) data by mid-next year and determine the optimal dose for Phase 2, with the aim to commence the Phase 2 trial in the latter half of the year.
Connext CEO Woojong Lee remarked, “This first administration marks a significant milestone, offering new hope to patients suffering from Dupuytren’s contracture. We are dedicated to developing a safer and more effective treatment to improve their quality of life.”
Connext successfully raised a Series B investment at the end of last year and was selected for the Scale-Up TIPS program, enabling the initiation of global clinical trials for Dupuytren’s contracture. The company is simultaneously advancing the development of additional indications, including Peyronie’s disease and cellulite.
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