Connext Completes Enrollment in Phase 2 Trial of CNT201 for Dupuytren's Contracture
核心洞察
Connext (搜索) completed enrollment of all 56 planned participants in the Phase 2 portion of its Phase 1/2 trial of CNT201 for Dupuytren's contracture (搜索), roughly five months after first patient dosing.
The randomized, double-blind, placebo-controlled Phase 2 study enrolled 24 participants in each of two dose groups and eight in the placebo group, with topline data expected in late 2026.
Positive results could support expansion of CNT201 into Peyronie's disease (搜索) and cellulite (搜索), with separate Phase 2a IND submissions planned for 2026.
Connext (搜索), a specialty therapeutics company focused on developing innovative therapies for significant unmet medical needs, has completed enrollment in the Phase 2 portion of its ongoing Phase 1/2 clinical trial evaluating CNT201 for the treatment of Dupuytren's contracture (搜索). All 56 planned participants have been enrolled approximately five months after the first patient was dosed, and the study has now advanced into the patient follow-up and data analysis phase. Based on the current trial timeline, Connext expects to report topline Phase 2 data in late 2026.
Connext (搜索) initiated the Phase 1/2 clinical trial of CNT201 in 2024 following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). The Phase 1 portion of the trial confirmed the safety and tolerability of CNT201, supporting advancement into Phase 2 in February 2026.
Phase 2 Study Design
The Phase 2 portion is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of CNT201 and support dose selection. The study enrolled 56 participants, including 24 participants in each of two selected dose groups and eight participants in the placebo group. Participants receive treatment at four-week intervals and may receive up to three doses based on treatment response. Follow-up assessments are designed to evaluate both durability of response and safety.
Potential Expansion into Follow-on Indications
Dupuytren's contracture (搜索) is the lead indication for CNT201. If the ongoing study demonstrates efficacy and safety, Connext (搜索) plans to use the findings to support further development of CNT201 in Peyronie's disease (搜索) and cellulite (搜索), two additional indications in which collagenase-based treatment may have therapeutic or aesthetic potential. Positive results in the lead indication could help reduce development risk for these follow-on programs and further support the broader value of CNT201.
Peyronie's disease (搜索) is characterized by the formation of fibrotic plaques in the penis, which can cause abnormal curvature, while cellulite (搜索) is associated with fibrous connective bands beneath the skin and the protrusion of underlying fat, resulting in a dimpled skin appearance. Treatment options remain limited in both areas, creating potential opportunities for differentiated injectable therapies.
Subject to the results of the Dupuytren's contracture (搜索) trial, Connext (搜索) plans to submit separate Phase 2a investigational new drug applications to the FDA in 2026 for Peyronie's disease (搜索) and cellulite (搜索). The company is also evaluating global co-development and licensing opportunities for CNT201.
"Completing enrollment in the Phase 2 portion of the CNT201 trial within approximately five months of first patient dosing marks an important clinical milestone for Connext (搜索)," said Woo Jong Lee, Chief Executive Officer of Connext. "With topline data expected in late 2026, we believe CNT201 has the potential to become a meaningful treatment option for patients with Dupuytren's contracture (搜索) and to serve as a platform for additional collagenase-based development opportunities in Peyronie's disease (搜索) and cellulite (搜索)."
Company Pipeline
Connext (搜索) is advancing CNT201 across a range of musculoskeletal and aesthetic indications and is also developing additional pipeline programs, including CNT101 for the treatment of radiation-induced toxicity and CNT202 for chronic wounds.