Curacle presented positive results from its Phase 2a clinical trial of CU06, an oral medication for diabetic macular edema (DME), at the 4th Asia Retina Congress held in conjunction with the 2024 Annual Meeting of the Korean Retina Society in Seoul. The study, conducted in the US, involved 67 patients and demonstrated improvements in visual acuity across all tested dosages.
Phase 2a Trial Results
The Phase 2a trial evaluated CU06 in DME patients over a three-month period. Participants were divided into three dosing groups receiving 100 mg, 200 mg, or 300 mg of the oral medication. The most significant improvement was observed in the 300 mg group, where patients with relatively low vision experienced a maximum gain of 5.8 letters in best corrected visual acuity. The study also indicated that higher doses and longer administration periods correlated with greater improvements in visual outcomes.
Central subfield thickness remained stable throughout the trial. Post-hoc analysis revealed dose-dependent improvements in anatomical markers, including reductions in retinal fluid and photoreceptor damage. Importantly, no serious adverse events related to CU06 were reported, confirming the drug's safety profile.
Expert Commentary
Professor Woo Se-jun of the Department of Ophthalmology at Seoul National University Bundang Hospital, who presented the trial results, commented on the potential mechanisms of action of CU06. "CU06 likely improved vision by targeting both exudate (edema) and non-exudate mechanisms," he stated. He also noted that the improved vision observed with higher doses and longer treatment durations supports the planning of a Phase 2b trial.
Future Development Plans
Curacle is moving forward with plans to finalize its development strategy for CU06, including the design of Phase 2b and Phase 3 trials. To this end, the company anticipates a Type C meeting with the US FDA in February 2025. Curacle expects that this meeting will provide clarity on the optimal development path for CU06, potentially accelerating licensing discussions with potential partners and marking a significant milestone for the drug's commercial prospects.
