Connext Completes Phase 2 Enrollment for CNT201 in Dupuytren's Contracture

All 56 Participants Enrolled in Approximately Five Months

Connext, a specialty therapeutics company developing treatments for significant unmet medical needs, has completed enrollment in the Phase 2 portion of its ongoing Phase 1/2 clinical trial evaluating CNT201 for Dupuytren's contracture.

The company enrolled all 56 participants planned for the Phase 2 study, reaching the milestone approximately five months after the first participant received a dose.

The trial has now moved into the follow-up and data analysis stage. Connext currently expects to report topline Phase 2 results in late 2026.

CNT201 Moves Into the Next Stage of Clinical Evaluation

Connext began its Phase 1/2 clinical trial of CNT201 in 2024 after the U.S. Food and Drug Administration cleared the company's investigational new drug application.

The Phase 1 portion of the study was designed to assess the safety and tolerability of CNT201.

The company reported that the Phase 1 results supported the continued development of CNT201 and allowed the program to move into Phase 2 in February 2026.

The latest enrollment milestone means Connext can now focus on evaluating how well the treatment works and how long any treatment response lasts.

What Is the Phase 2 Study Evaluating?

The Phase 2 portion is a randomized, double-blind and placebo-controlled study.

The main goals are to evaluate the efficacy of CNT201 and help determine the appropriate dose for future development.

A total of 56 participants were enrolled in the study.

Twenty-four participants were assigned to each of two selected CNT201 dose groups, while eight participants were assigned to the placebo group.

Participants receive treatment at four-week intervals. Depending on how they respond, they can receive up to three doses.

After treatment, participants are followed to assess both the durability of the response and the safety of CNT201.

Why Dupuytren's Contracture Is the Lead Indication

Dupuytren's contracture is a condition in which abnormal tissue in the hand becomes thickened and tight.

This can gradually pull one or more fingers toward the palm, making it difficult for patients to fully straighten their fingers or perform everyday activities.

Treatment options depend on the severity of the condition and can include injections, procedures or surgery.

Connext is developing CNT201 as a collagenase-based treatment for the condition.

The company is studying whether the therapy can provide an effective injectable treatment option while maintaining an acceptable safety profile.

Phase 2 Data Expected in Late 2026

With enrollment complete, Connext is now collecting follow-up information and analyzing the clinical data.

The company expects to report topline Phase 2 results in late 2026 based on the current development timeline.

The data will be important for determining whether CNT201 can move forward into later-stage development for Dupuytren's contracture.

The results will also help Connext decide how to design future studies and select the dose for continued development.

Connext Sees Potential Beyond Dupuytren's Contracture

Dupuytren's contracture is currently the lead indication for CNT201, but Connext is also looking at other possible uses for the same treatment.

The company plans to explore CNT201 in Peyronie's disease and cellulite if the Dupuytren's contracture program produces positive efficacy and safety results.

Both conditions involve fibrous connective tissue, which is relevant to the collagenase-based approach being developed by Connext.

CNT201 Could Be Studied in Peyronie's Disease

Peyronie's disease occurs when fibrotic plaques develop in the penis.

These plaques can cause abnormal curvature and may lead to pain or difficulties with sexual function.

Treatment options are available, but there is still a need for additional approaches that can provide meaningful benefits for patients.

Connext believes CNT201 could potentially be evaluated as an injectable treatment for this condition.

Subject to the results from the Dupuytren's contracture study, the company plans to submit a separate Phase 2a investigational new drug application to the FDA for Peyronie's disease in 2026.

Cellulite Is Another Potential Application

Connext is also considering CNT201 for cellulite.

Cellulite is associated with fibrous connective bands beneath the skin. These bands can pull the skin downward while underlying fat pushes upward, creating the familiar dimpled appearance.

Although cellulite is common, treatment options remain limited and results can vary.

Connext sees an opportunity to investigate whether its collagenase-based approach could be used to address the fibrous structures involved in cellulite.

A Phase 2a IND application for this indication is also planned for 2026, subject to the results of the ongoing Dupuytren's contracture program.

One Program Could Support Multiple Development Opportunities

The company believes that positive data from the Dupuytren's contracture trial could help reduce some of the development risk associated with the follow-on programs.

Instead of starting from the beginning with an entirely separate drug candidate, Connext could use clinical and development information generated from CNT201 in Dupuytren's contracture to inform future studies in Peyronie's disease and cellulite.

The company is also evaluating potential global co-development and licensing opportunities for CNT201.

Connext Highlights the Clinical Milestone

Woo Jong Lee, chief executive officer of Connext, said completing Phase 2 enrollment approximately five months after the first patient was dosed represents an important clinical milestone for the company.

He also said the company believes CNT201 could become a treatment option for patients with Dupuytren's contracture while supporting additional collagenase-based development programs.

The next major event for the program will be the release of the Phase 2 topline data, which is currently expected in late 2026.

Connext's Broader Pipeline

CNT201 is part of a broader pipeline being developed by Connext across musculoskeletal, aesthetic and other specialty indications.

The company is also developing CNT101 for radiation-induced toxicity and CNT202 for chronic wounds.

For CNT201, the immediate focus remains the ongoing Phase 2 evaluation in Dupuytren's contracture and the upcoming analysis of safety, efficacy and durability data.

The company will use these results to determine the next development steps for CNT201 and assess its potential in Peyronie's disease and cellulite.